Knee Osteoarthritis, Kidney Yin Deficiency, Kidney Yang Deficiency
Conditions
Keywords
Needling, Techniques, Randomized, Reinforcing, Reducing, Acupuncture
Brief summary
The thirty-nine-week open-label clinical study investigates the efficacy of acupuncture for Knee Osteoarthritis (KOA) as adjunctive therapy to analgesics compared to analgesics only and assesses the effects after 9 and 24 weeks, with safety assessment provided. The study seeks to find possible additional benefits of acupuncture on Kidney Deficiency (KD) while treating KOA with an acupuncture protocol designed to treat KOA following Traditional Chinese Medicine (TCM) theory, which connects KOA with KD as its root cause. The points prescription uses local and Kidney-related points to treat KOA. The chronic conditions require a higher number of acupuncture treatments. This study will provide acupuncture treatments in three cycles, each three weeks long, with frequency three times weekly. Twenty-seven acupuncture treatments of KOA during fifteen weeks tend to improve KOA and KDS; symptoms are assessed in 10 successive time points, and treatment effects and effect persistence are analysed. 64 patients with symptomatic KOA are randomly allocated into the Acupuncture (A) or Control (C) group according to their permanent, unique, and coincidental Personal Identification Number, which is randomly given to all citizens in Croatia. Before the experiment starts, demographics and disease parameters of all participants are compared. To objectify acupuncture effects, the enrolled physiatrist's measures included knee measures at 3 time points: baseline, at the end of acupuncture (Week 15), and nine weeks later (Week 24). Subjective evaluations of symptoms are assessed by Western Ontario and McMaster University Arthritis Index (WOMAC) total and subscales scores, Numeric Rating Scale (NRS), and Kidney Deficiency Syndrome Questionnaire (KDSQ) every 3 weeks till the 24th week (9 assessments). Analgesics taken by participants (DRUG) in the last three days before the assessments are recorded. Acupuncture treatment was promised to all participants. Therefore, at Week 25, the between-group analysis ended, and the C group crossed over to receive the identical acupuncture protocol. The 10th assessment in Week 39 was used to estimate, by within-group analysis, the immediate effects of the acupuncture in group C and the effect persistence in group A. The Lequesne index was introduced additionally at Week 24 as another measure of the knee's functional state.
Detailed description
KOA's high prevalence assures the trial's participation motivation of patients regarding associated pain and functional impairment. Besides pain and stiffness, patients experience muscle weakness, poor balance, and joint distortion in an advanced stage. KOA attacks the diseased ones at the age of 50. Pain worsens with joint loading and becomes relieved by rest. KOA supposes bones remodelling, cartilage thinning, synovial thickening, and joint space narrowing. The advanced stage is presented by joint instability, squaring, and even subluxation. KOA involves both knees and the contributing symptoms of old age from the scope of Kidney deficiency syndromes, such as weakness, insomnia, depression, tinnitus, forgetfulness, feeling cold, hot, low back pain, thirst at night, and disturbed urination could be manifested. The acupuncture treatment of KOA follows syndrome differentiation. The treatment principle distinguishes the deficient root (primary Kidney deficiency and secondary Blood deficiency) as the cause, and the excessive branch (knee bone Bi syndrome) when in empty Cou Li spaces, the external factor becomes entraped, consequently. An aspiration with treatment is to tonify the Kidney, nourish Qi, tonify and invigorate Blood, remove Damp and Cold by transferring them toward the deficiency rather than expelling, and relieve the channels and collaterals from the obstruction. Moreover, knee meridians should be dredged to improve knee symptoms by a simultaneous reinforcing-reducing technique on local points and reinforcing on KD-related points. Eventually, the improvements of KD indicate better life quality. The study's design involves two groups: an acupuncture (A) group that receives acupuncture treatment adjunctive to analgesics, and a control (C) group that receives only analgesics. Participants were recruited from the target population of patients over 50 from 2 Family Medicine practices with confirmed KOA. The study sample was formed with inclusion and exclusion criteria. 64 patients were recruited. All medical data of the participants were available to the investigator. After fulfilling the SOAP form (Subjective, Objective, Assessment, Plan) and getting informed written consent, the study sample was randomly allocated into two groups by size of their permanent, unique eleven-digit long Personal Identification Numbers (OIB), which is assigned to all Croatian citizens. Its first ten digits are accidentally chosen, and the last is a control number. Every second participant ordered by the size of OIB belongs to the same group; odd ones belong to the A group, and even ones to the C group. Demographic and disease parameters are compared at baseline to determine if the groups are comparable. All study participants received analgesics and could modify dosages according to their needs. Analgesics were nonsteroidal anti-inflammatory drugs (NSAIDs) and/or tramadol. Taken analgesics were recorded at Weeks 0, 3, 6, 9, 12, 15, 18, 21, 24, and 39. The dose represents an average daily dose of analgesics from the last three days. The dose was recorded after conversion to the comparable dose of the selected representative (ibuprofen), the most prescribed one. The given data will be statistically processed and analyzed. Patients in the A group started with acupuncture treatment in September 2021, with the first treatment cycle. Each of the 3 treatment cycles, in total, is three weeks long, each consists of 9 treatments, patients will receive acupuncture three times per week and the two adjacent acupuncture cycles are separated by three weeks without acupuncture. Acupuncture treatment protocol includes local treatment points Dubi (ST-35), Neixiyan (EX-LE-4) and Heding (EX-LE-2), Xuehai (SP-10), Yanglingquan (GB-34), Yinlingquan (SP-9), Zusanli (ST-36), Sanyinjiao (SP-6), and points targeting Kidney deficiency syndrome Taixi (KI-3), Guanyuan (CV 4), and Shenshu (BL-23). Disposable sterile acupuncture needles 0.30 × 40 mm are used. The depth and angle procedure predicted straight needling on 1-1.5 inches deep, with a mild reinforcing-reducing method for local points, further straight and 0.5-1 inch deep with the reinforcing method for points based on KD syndromes. Complete treatment lasts 30 minutes, and the manipulations are provided every 10 minutes, three times in total. The sample size was calculated based on the Berman et al. (1999) study. The sample size was calculated by envisioning a two-sided test with unequal variances: type I error 0,05, power 0,95. Group sample sizes of 16 and 16 (i.e. complete study population of 32 subjects) achieve 95,78% power to reject the null hypothesis of equal means and with a significance level (alpha) of 0,050 using a two-sided two-sample unequal-variance t-test. From a longer treatment period of this study and higher participants' drop-off expected, the population was doubled to 64 subjects in total. Research methods were determined upon the clinical question Could the prolonged design of acupuncture treatments on patients with knee osteoarthritis (KOA) decrease pain and improve the function of the knee joints and additionally achieve positive effects on the debilitating symptoms of a Kidney deficiency as a root cause of KOA, measured by recognized questionnaires?. Evaluation of the therapeutic effects of acupuncture on KOA included WOMAC, VAS, KDSQ scores, and DRUG at Weeks 0, 3, 6, 9, 12, 15, 18, 21, 24, and 39. WOMAC is a renowned questionnaire for KOA evaluation. It measures 5 items for pain, 2 for stiffness, and 17 for functional limitation. VAS is a continuous numeric rating scale of 100 mm in length that is widely used for pain intensity assessment. The KDSQ questionnaire is a valid and reliable measure constructed in 2012 to evaluate Kidney Yin and Yang deficiency syndromes of Hong Kong Chinese middle-aged women by Chen et al. KDSQ represents a valid questionnaire for KD assessment in this study population. From a total of 10 assessments, the first 9 compared scores between groups A and C. Participants were promised to receive equal acupuncture treatment if they were randomised into the C group. So, group C crossed over to receive the identical protocol from Week 25 to 39, and the 10th assessment was added to both groups of participants to estimate the immediate effects of the acupuncture treatment in the C group and estimate treatment effect persistence in the A group over 24 weeks, in a within-group manner. The physiatrist's assessments at 3 time-points (baseline, 15th Week, and 24th Week) include the standard physiatrist KOA measurements (knee and thigh circumference, range of motion of the knee). The Lequesne index was added as the knee's functional state measure in Week 24. Data is stored electronically with secured and restricted access. Data transfer will be encrypted, and all data that could identify individuals has been removed. Study analysis serves to process the effects of acupuncture treatment. Baseline data are obtained before the experiment starts. Besides immediate effects, effects persistence was assessed at Weeks 24 (9 weeks after acupuncture of group A ended) and 39. WOMAC total score at the end of the acupuncture protocol (Week 15) is a primary outcome, while WOMAC subscales, VAS, and KDSQ scores, DRUG at Weeks 15, 24 and 39, and persistence of WOMAC total were secondary and supportive of the primary one. Secondary outcome measures include physiatrists' measures and the Lequesne index as well. Effect sizes are calculated from data comparison to the control group up to Week 24 or baseline at Week 39. Analyses were performed on 64 participants, randomised for the intention-to-treat (ITT) analysis using the maximum available data set (i.e. excluding the missing values) from repeated measures of variables of interest and their variances. ITT analysis, excluding missing values, was selected regarding dropouts that emerged in the study, completely random without any causal clustering. Dropouts produced missing values. Omitting missing values can compromise the statistics and produce bias. Therefore, sensitivity analyses were provided to compare those who dropped out and those who completed the study to determine if data significantly differed. Also, a test calculation with the Last observation carried forward technique (LOCF) with the imputed last observed value in the missing one was performed to check if the obtained effects still stand. All statistical tests are two-sided. The Shapiro-Wilk test tests the normality distribution. The non-parametric Mann-Whitney U test was used for comparability testing with 95% power and α=0,05. The main efficacy indicators tested the comparability of the groups with the Mann-Whitney U test and quantified observed effects by mean differences and Cohen's d. A participant will be considered to have withdrawn from the trial when consent is revoked or if the participant cannot be contacted or located. Participants will not be withdrawn from the trial for protocol violations. Withdrawal due to an adverse event should be distinguished from withdrawal due to insufficient response. All adverse events will be recorded in the Adverse Event Report Form at every treatment. If this happens, an adverse event will be followed until its resolution. The serious adverse event must be reported to the Medical Ethics Committee. It is expected to relieve pain and increase joint mobility, along with alleviating KD and reducing the use of analgesics and confirming the safety of acupuncture. This is a prospective, interventional, randomized, open-label, controlled trial. It is supported by recent scholarly, peer-reviewed literature. The research method reflects the approach needed to answer the research questions. Research is addressing a gap in the literature that would contribute new findings. The research topic is based on a tangible and cited problem. The research collects and analyses the data, any deviations are documented and approved by NJUCM. The study was designed originally. The acupuncture treatment plan for KOA is designed with the assistance of Professor Xueping Zhou. The study will be conducted in a Family Medicine practice by the experimenter. All financial and operating burdens will be funded from practice resources.
Interventions
PROCEDUREAcupuncture
Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment is 30 minutes. All treatments will be equal.
Participants could take their standard conventional medical treatment or analgesics. Analgesics therapy is prescribed by their general practitioner. The dose of analgesics could be modified according to participants' symptoms intensity.
Sponsors
Nanjing University of Chinese Medicine, Xueping Zhou, Li Ren
School of Medicine, University of Zagreb, Pero Hrabac
Health Center Zagreb East, Ljiljana Karadakic
Svijetlana Perculija Durdevic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The assessor of the physiatrists' measures and the assessor in charge of helping fill in WOMAC, VAS, KDSQ, DRUG, and Lequesne index were blind to the fact to which group participants belonged.
Intervention model description
A randomized, controlled, interventional, prospective.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Knee Osteoarthritis * Knee Osteoarthritis for at least 6 months * painful knee in last month * radiographic changes of the knee (Kellgren-Lawrence grade 2 or more) * signed informed consent * participant can move independently
Exclusion criteria
* if the participant got knee intra-articular injection 3 months before his entry into the study * uncontrolled malignant disease * unstable heart disease * advanced organ failure disease (NYHA III or IV, or a more than the twofold increase of creatinin, or marked dyspnea) * unstable psychiatrist's disease * bleeding diathesis * anticoagulant use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC Total in Week 15 | Week 15 | The Western Ontario and McMaster University Osteoarthritis Index (WOMAC) total score is the sum of the three subscales: pain, stiffness, and functional disability. The minimum value is 0, and the maximum value is 96, where the lower score/value represents a better outcome, and the higher score/value represents a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC Stiffness in Week 15 | Week 15 | Western Ontario and McMaster University Osteoarthritis (WOMAC) stiffness subscale, separated from the WOMAC index, and evaluate knee OA stiffness by participants. It comprises 2 questions for stiffness assessed by a 5-point Likert scale between the range from minimal 0 to maximal 8 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC stiffness measures the stiffness of the knees. |
| WOMAC Functional Disability in Week 15 | Week 15 | Western Ontario and McMaster University Osteoarthritis (WOMAC) functional disability subscale, separated from the WOMAC index, evaluates knee OA functional disability by participants' estimation. It comprises 17 items for functional disability assessment by a 5-point Likert scale ranging from minimal 0 to maximal 68 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC functional disability measures climbing, rising from a chair/bed, standing, bending, walking, getting in/out of a car/bath/toilet, shopping, putting on socks, sitting and difficulties in domestic duties. |
| VAS in Week 15 | Week 15 | Visual Analogue Scale (VAS) assesses knee OA pain intensity, ranging from 0 to 100; the lower value represents a better outcome, and the higher a worse outcome. |
| KDSQ in Week 15 | Week 15 | The Kidney Deficiency Syndrome Questionnaire (KDSQ) assesses the intensity of Kidney deficiency (KD) symptoms; the minimum value is 0, and the maximum is 69. A lower score/value represents a better outcome, and a higher score/value represents a worse outcome. This measure represents the effect of acupuncture treatment on KD. |
| DRUG in Week 15 | Week 15 | DRUG is a measure that represents analgesics taken by participants, including various non-steroid anti-inflammatory drugs (NSAIDS) and/or tramadol. Recorded analgesics' doses from the last three days before assessment were recalculated in the comparable dose of the selective representative (ibuprofen) and converted into equivalent dose of milligrams of ibuprofen-ibuprofen equivalent units (IBU). DRUG's units of measure are IBU (units) on the scale ranging from 0 IBU to 4.500 IBU. DRUG decreasement represents a better therapeutic outcome, and an increase in DRUG represents a worse therapeutic outcome. All participants could self-manage the dosage according to their pain. |
| Active Extension L and R Knees in Week 15 | Week 15 | The active extension of the left (L) and right (R) knees in Week 15 is an objective measure taken by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle as units. Knee active extension ranges between 0 and 5 degrees: the higher scores represent knee laxity/instability, and the negative scores represent knee flexion contraction. The higher values represent worse outcomes, and the lower values represent better outcomes. |
| Active Flexion L and R Knees in Week 15 | Week 15 | Active flexion of left (L) and right (R) knees in Week 15 is an objective measure provided by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle (units). Knee active flexion ranges from 0 to a maximum of 135 degrees; the lower score/value represents a worse outcome, and the higher score/value a better one. |
| Circumference of L and R Upper Leg in Week 15 | Week15 | Circumference of the left (L) and right (R) upper leg in Week 15 is an objective measure, assessed by an independent physiatrist, at the thigh 15 centimetres above the patellar superior margin, measured with a tape measure. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents a measure of muscular strength or atrophy. Higher values indicate better outcomes from higher muscular volume, and decreased values indicate worse outcomes from weaker muscular volume. |
| Circumference of L and R Knees in Week 15 | Week 15 | Circumference of left (L) and right (R) knees at Week 15 is an objective measurement taken by an independent physiatrist; the measure includes the difference in circumference of the knees measured with a tape measure at the middle of the patellae. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents knee inflammation and joint deformation (abnormal bone growth). Increased values indicate worse outcomes from a higher level of knee inflammation/deformation, and decreased values indicate better outcomes from a lower level of knee inflammation/deformation. |
| WOMAC Total in Week 24 | Week 24 | Western Ontario and McMaster University Osteoarthritis (WOMAC) index's total score is a sum of all three subscales for pain, stiffness, and functional disability, the minimum value is 0, and the maximum value is 96; the lower score/value represents a better outcome, and a higher score/value represents a worse outcome |
| WOMAC Pain in Week 24 | Week 24 | Western Ontario and McMaster University Osteoarthritis (WOMAC) pain subscale, separated from the WOMAC index, evaluates OA pain by participants. It comprises 5 questions for pain assessed by a 5-point Likert scale, ranging from minimal 0 to maximal 20 points. A bigger score presents a worse outcome, and a lower score relates to a better one. |
| WOMAC Stiffness in Week 24 | Week 24 | Western Ontario and McMaster University Osteoarthritis (WOMAC) stiffness subscale, separated from the WOMAC index, evaluates knee OA stiffness by participants. It comprises 2 questions for stiffness assessed by a 5-point Likert scale ranging from minimal 0 to maximal 8 points. A bigger score represents a worse outcome, and a lower score relates to a better result. WOMAC stiffness measures the stiffness of the knees. |
| WOMAC Functional Disability in Week 24 | Week 24 | Western Ontario and McMaster University Osteoarthritis (WOMAC) functional disability subscale, separated from the WOMAC index, evaluates knee OA functional disability by participants' estimation. It comprises 17 items of functional disability assessment by a 5-point Likert scale ranging from minimal 0 to maximal 68 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC functional disability measures climbing, rising from a chair/bed, standing, bending, walking, getting in/out of a car/bath/toilet, shopping, putting on socks, sitting, and difficulties in domestic duties. |
| VAS in Week 24 | Week 24 | Visual Analogue Scale (VAS) assesses knee OA pain intensity, ranging from 0 to 100; the lower value represents a better outcome, and the higher a worse outcome. |
| WOMAC Pain in Week 15 | Week 15 | Western Ontario and McMaster University Osteoarthritis (WOMAC) pain subscale, separated from the WOMAC index, evaluates knee OA pain by participants. It comprises 5 questions for pain assessed by a 5-point Likert scale ranging from minimal 0 to maximal 20 points. A bigger score presents a worse outcome, and a lower score relates to a better outcome. |
| DRUG in Week 24 | Week 24 | DRUG is a measure that represents analgesics taken by participants, including various non-steroid anti-inflammatory drugs (NSAIDS) and/or tramadol. Recorded analgesics' doses from the last three days before assessment were recalculated in the comparable dose of the selective representative (ibuprofen) and converted into equivalent dose of milligrams of ibuprofen-ibuprofen equivalent units (IBU). DRUG's units of measure are IBU (units) on the scale ranging from 0 IBU to 4.500 IBU. DRUG decreasement represents a better therapeutic outcome, and an increase in DRUG represents a worse therapeutic outcome. All participants could self-manage the dosage according to their pain. |
| Active Extension L and R Knee in Week 24 | Week 24 | The active extension of the left (L) and right (R) knees in Week 15 is an objective measure taken by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle as units. Knee active extension ranges between 0 and 5 degrees: the higher scores represent knee laxity/instability, and the negative scores represent knee flexion contraction. The higher values represent worse outcomes, and the lower values represent better outcomes. |
| Active Flexion L and R Knees in Week 24 | Week 24 | Active flexion of left (L) and right (R) knees in Week 15 is an objective measure provided by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle (units). Knee active flexion ranges from 0 to a maximum of 135 degrees; the lower score/value represents a worse outcome, and the higher score/value a better one. |
| Circumference of L and R Upper Leg in Week 24 | Week 24 | Circumference of the left (L) and right (R) upper leg in Week 24 is an objective measure, assessed by an independent physiatrist, at the thigh 15 centimetres above the patellar superior margin, measured with a tape measure. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents a measure of muscular strength or atrophy. Higher values indicate better outcomes from higher muscular volume, and decreased values indicate worse outcomes from weaker muscular volume. |
| Circumference of L and R Knee in Week 24 | Week 24 | Circumference of the left (L) and right (R) upper leg in Week 24 is an objective measure, assessed by an independent physiatrist, at the thigh 15 centimetres above the patellar superior margin, measured with a tape measure. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents a measure of muscular strength or atrophy. Higher values indicate better outcomes from higher muscular volume, and decreased values indicate worse outcomes from weaker muscular volume. |
| WOMAC Total in Week 39 | Week 39 | Western Ontario and McMaster University Osteoarthritis (WOMAC) total at the Added assessment at Week 39 in the crossover part compared to pre-experimental baseline value. The total score is a sum of all three subscales: pain, stiffness, and functional limitation. The minimum value is 0, and the maximum value is 96, where the lower score/value represents a better outcome, and a higher score/value represents a worse outcome. |
| WOMAC Pain in Week 39 | Week 39 | The Western Ontario and McMaster University Osteoarthritis (WOMAC) pain subscale, selected from the WOMAC index, evaluates knee OA pain by participants. It comprises 5 questions for pain assessed by a 5-point Likert scale, ranging from minimal 0 to maximal 20 points. A bigger score presents a worse outcome, and a lower score relates to a better one. |
| WOMAC Stiffness in Week 39 | Week 39 | Western Ontario and McMaster University Osteoarthritis (WOMAC) stiffness subscale, separated from the WOMAC index, evaluates knee OA stiffness by participants. It comprises 2 questions for stiffness assessed by a 5-point Likert scale ranging from minimal 0 to maximal 8 points. A bigger score represents a worse outcome, and a lower score relates to a better result. WOMAC stiffness measures the stiffness of the knees. |
| WOMAC Functional Disability in Week 39 | Week 39 | Western Ontario and McMaster University Osteoarthritis (WOMAC) functional disability subscale, separated from the WOMAC index, evaluates knee OA functional disability by participants' estimation. It comprises 17 items for functional disability assessment by a 5-point Likert scale ranging from minimal 0 to maximal 68 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC functional disability measures climbing, rising from a chair/bed, standing, bending, walking, getting in/out of a car/bath/toilet, shopping, putting on socks, sitting and difficulties in domestic duties. |
| VAS in Week 39 | Week 39 | Visual Analogue Scale (VAS) assesses knee OA pain intensity, ranging from 0 to 100; the lower value represents a better outcome, and the higher a worse outcome. This measure estimates the treatment effect of acupuncture on knee pain in Week 39 separately for groups A and C. |
| KDSQ in Week 39 | Week 39 | The Kidney Deficiency Syndrome Questionnaire (KDSQ) assesses the intensity of Kidney deficiency symptoms; the minimum value is 0, and the maximum is 69. A lower score/value represents a better outcome, and a higher score/value represents a worse outcome. This outcome represents the treatment effect of acupuncture on Kidney deficiency symptoms for both groups separately. |
| DRUG by Added Assessment in Week 39, Crossover Part | Week 39 | DRUG is a measure that represents analgesics taken by participants, including various non-steroid anti-inflammatory drugs (NSAIDS) and/or tramadol. Recorded analgesics' doses from the last three days before assessment were recalculated in the comparable dose of the selective representative (ibuprofen) and converted into equivalent dose of milligrams of ibuprofen-ibuprofen equivalent units (IBU). DRUG's units of measure are IBU (units) on the scale ranging from 0 IBU to 4.500 IBU. DRUG decreasement represents a better therapeutic outcome, and an increase in DRUG represents a worse therapeutic outcome. All participants could self-manage the dosage according to their pain. |
| Lequesne Index in Week 24, Between-group Analysis | Week 24 | The Lequesne index is an algofunctional index of knee osteoarthritis that comprises three sections. Its score ranges from a minimal 0 (no pain and disability) to 24 (the greatest pain and disability). This index is added to the study in Week 24 as an additional objective measure. It measures pain severity with 5 questions, walking distance with 2 questions, and activities of daily living with 4 questions. |
| KDSQ in Week 24 | Week 24 | The Kidney Deficiency Syndrome Questionnaire (KDSQ) assesses the intensity of kidney deficiency symptoms; the minimum value is 0, and the maximum is 69. A lower score/value represents a better outcome, and a higher score/value represents a worse outcome. This measure represents the effect of acupuncture treatment on Kidney deficiency (KD). |
Countries
Croatia
Participant flow
Recruitment details
The recruitment process was carried out from January 2021 to August 2021. The recruitment was performed at the Family Medicine practice, run by the investigator, who has access to the database of four thousand patients from two practices. From the 4000 patients, 180 made the target population by criteria ≥50 years and confirmed KOA from a computer database. A study population of 64 participants was made by applying the inclusion and exclusion criteria.
Pre-assignment details
In the pre-assignment period, all 64 enrolled participants were assigned in a concealed manner to the A or C group.
Participants by arm
| Arm | Count |
|---|---|
| Acupuncture Group Participants in the Acupuncture (A) group got acupuncture treatments for their knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with a frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) whose dose varied according to participant symptoms intensity. The participants and investigator were not blinded by treatment type. The assessors were blinded for the fact to which group participants belong.
Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles were manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long.
Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms. | 32 |
| Control Group Participants in the Control (C) group got their standard conventional treatment (analgesics) whose dose could vary according to the participants' symptoms intensity. Participants and investigator were not blinded for treatment type. The assessors were blinded for the fact to which group participants belong.
Conventional Medical Treatment: Participants took their standard conventional medical treatment or analgesics. Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms. | 32 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Week 1-24, Between Group Analysis | Lost to Follow-up | 1 | 0 |
| Week 1-24, Between Group Analysis | Withdrawal by Subject | 6 | 3 |
| Week 25-39, Within Group Analysis | Lost to Follow-up | 2 | 1 |
| Week 25-39, Within Group Analysis | Withdrawal by Subject | 0 | 5 |
Baseline characteristics
| Characteristic | Total | Control Group | Acupuncture Group |
|---|---|---|---|
| Active extension L and R knee, Continuous Active extension L knee | 0.54 degree of angle STANDARD_DEVIATION 1.643 | 0.5 degree of angle STANDARD_DEVIATION 1.526 | 0.586 degree of angle STANDARD_DEVIATION 1.783 |
| Active extension L and R knee, Continuous Active extension R knee | 0.63 degree of angle STANDARD_DEVIATION 1.973 | 0.5 degree of angle STANDARD_DEVIATION 1.526 | 0.759 degree of angle STANDARD_DEVIATION 2.37 |
| Active flexion L and R knees, Continuous Active flexion L knee | 92.08 degree of angle STANDARD_DEVIATION 20.7 | 89.167 degree of angle STANDARD_DEVIATION 23.159 | 95.103 degree of angle STANDARD_DEVIATION 17.707 |
| Active flexion L and R knees, Continuous Active flexion R knee | 91.02 degree of angle STANDARD_DEVIATION 19.36 | 88.666 degree of angle STANDARD_DEVIATION 21.573 | 93.448 degree of angle STANDARD_DEVIATION 16.802 |
| Age, Continuous | 64.4 years STANDARD_DEVIATION 8.05 | 64.7 years STANDARD_DEVIATION 8.27 | 64.1 years STANDARD_DEVIATION 7.94 |
| Body Mass Index (BMI), Continuous | 31.0 kg/m2 STANDARD_DEVIATION 5.55 | 30.6 kg/m2 STANDARD_DEVIATION 5.7 | 31.4 kg/m2 STANDARD_DEVIATION 5.45 |
| Circumference of L and R knee, Continuous Circumference of L knee | 42.29 centimeter STANDARD_DEVIATION 3.773 | 41.973 centimeter STANDARD_DEVIATION 3.279 | 42.610 centimeter STANDARD_DEVIATION 4.26 |
| Circumference of L and R knee, Continuous Circumference of R knee | 42.48 centimeter STANDARD_DEVIATION 3.931 | 42.013 centimeter STANDARD_DEVIATION 3.168 | 42.966 centimeter STANDARD_DEVIATION 4.598 |
| Circumference of L and R upper leg, Continuous Circumference of L upper leg | 56.75 centimeter STANDARD_DEVIATION 5.914 | 55.607 centimeter STANDARD_DEVIATION 5.755 | 57.931 centimeter STANDARD_DEVIATION 5.941 |
| Circumference of L and R upper leg, Continuous Circumference of R upper leg | 57.17 centimeter STANDARD_DEVIATION 5.66 | 56.26 centimeter STANDARD_DEVIATION 5.613 | 58.121 centimeter STANDARD_DEVIATION 5.648 |
| DRUG /IBU, Continuous | 631.3 milligram-equivalent of ibuprofen STANDARD_DEVIATION 969.352 | 625 milligram-equivalent of ibuprofen STANDARD_DEVIATION 841.66 | 637.5 milligram-equivalent of ibuprofen STANDARD_DEVIATION 1095.96 |
| KDSQ, Continuous | 26.7 score on a scale STANDARD_DEVIATION 11.427 | 26.2 score on a scale STANDARD_DEVIATION 11.89 | 27.2 score on a scale STANDARD_DEVIATION 11.105 |
| Kellgren-Lawrence (K-L) grade, Categorical grade 2 | 16 Participants | 9 Participants | 7 Participants |
| Kellgren-Lawrence (K-L) grade, Categorical grade 3 | 32 Participants | 13 Participants | 19 Participants |
| Kellgren-Lawrence (K-L) grade, Categorical grade 4 | 16 Participants | 10 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 64 Participants | 32 Participants | 32 Participants |
| Sex: Female, Male Female | 49 Participants | 24 Participants | 25 Participants |
| Sex: Female, Male Male | 15 Participants | 8 Participants | 7 Participants |
| VAS, Continuous | 59.3 score on a scale STANDARD_DEVIATION 20.41 | 59.1 score on a scale STANDARD_DEVIATION 18.11 | 59.5 score on a scale STANDARD_DEVIATION 22.767 |
| WOMAC functional disability, Continuous | 41.5 score on a scale STANDARD_DEVIATION 14.292 | 41.9 score on a scale STANDARD_DEVIATION 14.88 | 40.8 score on a scale STANDARD_DEVIATION 14.123 |
| WOMAC pain, Continuous | 11.6 score on a scale STANDARD_DEVIATION 4.457 | 11.7 score on a scale STANDARD_DEVIATION 4.37 | 11.5 score on a scale STANDARD_DEVIATION 4.607 |
| WOMAC stiffness, Continuous | 4.0 score on a scale STANDARD_DEVIATION 1.877 | 4.2 score on a scale STANDARD_DEVIATION 2.2 | 3.8 score on a scale STANDARD_DEVIATION 1.505 |
| WOMAC total, Continuous | 56.9 score on a scale STANDARD_DEVIATION 19.414 | 57.3 score on a scale STANDARD_DEVIATION 20.2 | 56.4 score on a scale STANDARD_DEVIATION 18.908 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 2 / 32 | 1 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
WOMAC Total in Week 15
The Western Ontario and McMaster University Osteoarthritis Index (WOMAC) total score is the sum of the three subscales: pain, stiffness, and functional disability. The minimum value is 0, and the maximum value is 96, where the lower score/value represents a better outcome, and the higher score/value represents a worse outcome.
Time frame: Week 15
Population: WOMAC total in Week 15 estimates the immediate treatment effects of acupuncture on pain, stiffness and knee function when acupuncture treatments ended in a between-groups A and C analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | WOMAC Total in Week 15 | 11.6 score on a scale | Standard Deviation 11.633 |
| C Group in Week 15 | WOMAC Total in Week 15 | 54.4 score on a scale | Standard Deviation 19.4 |
Comparison: WOMAC total analysis between groups at Week 15. The Shapiro-Wilk test (S-W) was used for testing the normality of the data distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Active Extension L and R Knee in Week 24
The active extension of the left (L) and right (R) knees in Week 15 is an objective measure taken by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle as units. Knee active extension ranges between 0 and 5 degrees: the higher scores represent knee laxity/instability, and the negative scores represent knee flexion contraction. The higher values represent worse outcomes, and the lower values represent better outcomes.
Time frame: Week 24
Population: Active extension of L and R knee in Week 24 represents the treatment effect of acupuncture on the knee OA, nine weeks after the acupuncture treatment ended, compared between groups A and C.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A Group in Week 15 | Active Extension L and R Knee in Week 24 | Active extension of L knee at Week 24 | 0 degrees of a goniometer angle | Standard Deviation 0 |
| A Group in Week 15 | Active Extension L and R Knee in Week 24 | Active extension of R knee at Week 24 | 0 degrees of a goniometer angle | Standard Deviation 0 |
| C Group in Week 15 | Active Extension L and R Knee in Week 24 | Active extension of L knee at Week 24 | 0 degrees of a goniometer angle | Standard Deviation 0 |
| C Group in Week 15 | Active Extension L and R Knee in Week 24 | Active extension of R knee at Week 24 | 0 degrees of a goniometer angle | Standard Deviation 0 |
Comparison: Left (L) knee analysis between groups A and C in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of comparability was tested with the Mann-Whitney U test, with 95% statistical power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at assessment.
Comparison: Right (R) knee analysis between groups at Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of comparability between groups was tested by the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at specified assessment.
Secondary
Active Extension L and R Knees in Week 15
The active extension of the left (L) and right (R) knees in Week 15 is an objective measure taken by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle as units. Knee active extension ranges between 0 and 5 degrees: the higher scores represent knee laxity/instability, and the negative scores represent knee flexion contraction. The higher values represent worse outcomes, and the lower values represent better outcomes.
Time frame: Week 15
Population: Active extension of L and R knees in Week 15 represents the treatment effect of acupuncture on the knee OA at the completed acupuncture treatment time point in Week 15, compared between groups A and C.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A Group in Week 15 | Active Extension L and R Knees in Week 15 | L knee active extension | 0.429 degrees of a goniometer angle | Standard Deviation 1.6 |
| A Group in Week 15 | Active Extension L and R Knees in Week 15 | R knee active extension | 0.607 degrees of a goniometer angle | Standard Deviation 2.27 |
| C Group in Week 15 | Active Extension L and R Knees in Week 15 | L knee active extension | 0.42 degrees of a goniometer angle | Standard Deviation 1.35 |
| C Group in Week 15 | Active Extension L and R Knees in Week 15 | R knee active extension | 0.714 degrees of a goniometer angle | Standard Deviation 1.78 |
Comparison: Active extension of left (L) knees in Week 15 in the between-group analysis. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.p-value: 0.8493Wilcoxon (Mann-Whitney)
Comparison: Active extension of the right (R) knees in Week 15 in the between-group analysis. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.p-value: 0.69654Wilcoxon (Mann-Whitney)
Secondary
Active Flexion L and R Knees in Week 15
Active flexion of left (L) and right (R) knees in Week 15 is an objective measure provided by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle (units). Knee active flexion ranges from 0 to a maximum of 135 degrees; the lower score/value represents a worse outcome, and the higher score/value a better one.
Time frame: Week 15
Population: Active flexion of L and R knees in Week 15 represents the treatment effect of acupuncture on knee function at the end of acupuncture treatment, Week 15, between groups A and C at Week 15.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A Group in Week 15 | Active Flexion L and R Knees in Week 15 | L knee active flexion | 94.1 degrees on a goniometer angle | Standard Deviation 17.1 |
| A Group in Week 15 | Active Flexion L and R Knees in Week 15 | R knee active flexion | 96.1 degrees on a goniometer angle | Standard Deviation 17.3 |
| C Group in Week 15 | Active Flexion L and R Knees in Week 15 | L knee active flexion | 90.2 degrees on a goniometer angle | Standard Deviation 18.9 |
| C Group in Week 15 | Active Flexion L and R Knees in Week 15 | R knee active flexion | 91.4 degrees on a goniometer angle | Standard Deviation 18.6 |
Comparison: L knee flexion between groups at Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.p-value: 0.49Wilcoxon (Mann-Whitney)
Comparison: Right (R) knee flexion between groups in Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.p-value: 0.517Wilcoxon (Mann-Whitney)
Secondary
Active Flexion L and R Knees in Week 24
Active flexion of left (L) and right (R) knees in Week 15 is an objective measure provided by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle (units). Knee active flexion ranges from 0 to a maximum of 135 degrees; the lower score/value represents a worse outcome, and the higher score/value a better one.
Time frame: Week 24
Population: Active flexion of L and R knees in Week 24 represents the treatment effect of acupuncture on knee function nine weeks after acupuncture treatment ended, compared between groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A Group in Week 15 | Active Flexion L and R Knees in Week 24 | L knee | 98.6 degrees of a goniometer angle | Standard Deviation 16.4 |
| A Group in Week 15 | Active Flexion L and R Knees in Week 24 | R knee | 101.6 degrees of a goniometer angle | Standard Deviation 22.1 |
| C Group in Week 15 | Active Flexion L and R Knees in Week 24 | L knee | 99.5 degrees of a goniometer angle | Standard Deviation 24.8 |
| C Group in Week 15 | Active Flexion L and R Knees in Week 24 | R knee | 99.8 degrees of a goniometer angle | Standard Deviation 21.5 |
Comparison: Left (L) knee flexion between groups at Week 24. The Shapiro-Wilk test (S-W) tests the normality of the distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the null hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a level of significance α = 0,05. Standard deviation (SD) was calculated to present the statistical dispersion of specified sample data at a specified assessment (time-point).p-value: 0.953Wilcoxon (Mann-Whitney)
Comparison: Right (R) knee flexion between groups at Week 24. The Shapiro-Wilk test (S-W) tests the normality of the distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the null hypothesis of comparability was tested with the Mann-Whitney U test, with 95% power and a level of significance α = 0,05. Standard deviation (SD) was calculated to present the statistical dispersion of sample data at an assessment.p-value: 0.491Wilcoxon (Mann-Whitney)
Secondary
Circumference of L and R Knee in Week 24
Circumference of the left (L) and right (R) upper leg in Week 24 is an objective measure, assessed by an independent physiatrist, at the thigh 15 centimetres above the patellar superior margin, measured with a tape measure. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents a measure of muscular strength or atrophy. Higher values indicate better outcomes from higher muscular volume, and decreased values indicate worse outcomes from weaker muscular volume.
Time frame: Week 24
Population: Circumference of L and R Knee in Week 24 estimates the direct treatment effect of acupuncture on knee osteoarthritis, nine weeks after acupuncture treatment ended, analysed between groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A Group in Week 15 | Circumference of L and R Knee in Week 24 | Circumference of L knees at Week 24 in between-groups | 43.6 centimeters | Standard Deviation 4.62 |
| A Group in Week 15 | Circumference of L and R Knee in Week 24 | Circumference of R knees at Week 24 in between-groups | 44.0 centimeters | Standard Deviation 4.38 |
| C Group in Week 15 | Circumference of L and R Knee in Week 24 | Circumference of L knees at Week 24 in between-groups | 42.4 centimeters | Standard Deviation 4.14 |
| C Group in Week 15 | Circumference of L and R Knee in Week 24 | Circumference of R knees at Week 24 in between-groups | 42.4 centimeters | Standard Deviation 4.08 |
Comparison: Circumference of left (L) knees in Week 24, in between-groups. The Shapiro-Wilk test (S-W) tests normality distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of similarity was tested with the Mann-Whitney U test with 95% power and a level of significance α = 0,05. Standard deviation was calculated to present the statistical dispersion of sample data at an assessment.p-value: 0.445Wilcoxon (Mann-Whitney)
Comparison: Circumference of right (R) knees at Week 24 was analysed between groups. The Shapiro-Wilk test (S-W) tests normality distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of similarity was tested with the Mann-Whitney U test with 95% power and a level of significance α = 0,05. Standard deviation was calculated to present the statistical dispersion of sample data at assessments.p-value: 0.26Wilcoxon (Mann-Whitney)
Secondary
Circumference of L and R Knees in Week 15
Circumference of left (L) and right (R) knees at Week 15 is an objective measurement taken by an independent physiatrist; the measure includes the difference in circumference of the knees measured with a tape measure at the middle of the patellae. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents knee inflammation and joint deformation (abnormal bone growth). Increased values indicate worse outcomes from a higher level of knee inflammation/deformation, and decreased values indicate better outcomes from a lower level of knee inflammation/deformation.
Time frame: Week 15
Population: Circumference of L and R knees in Week 15 estimates the treatment effect of acupuncture on knee osteoarthritis at the end of the acupuncture treatment time point, analysed between groups A and C.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A Group in Week 15 | Circumference of L and R Knees in Week 15 | L knee circumference | 43.1 centimeters | Standard Deviation 3.9 |
| A Group in Week 15 | Circumference of L and R Knees in Week 15 | R knee circumference | 43.1 centimeters | Standard Deviation 4.14 |
| C Group in Week 15 | Circumference of L and R Knees in Week 15 | L knee circumference | 41.8 centimeters | Standard Deviation 3.23 |
| C Group in Week 15 | Circumference of L and R Knees in Week 15 | R knee circumference | 41.8 centimeters | Standard Deviation 3 |
Comparison: Circumference of the left (L) knee in Week 15 was analysed between groups. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.p-value: 0.341Wilcoxon (Mann-Whitney)
Comparison: Circumference of the right (R) knee in between groups at Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.p-value: 0.317Wilcoxon (Mann-Whitney)
Secondary
Circumference of L and R Upper Leg in Week 15
Circumference of the left (L) and right (R) upper leg in Week 15 is an objective measure, assessed by an independent physiatrist, at the thigh 15 centimetres above the patellar superior margin, measured with a tape measure. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents a measure of muscular strength or atrophy. Higher values indicate better outcomes from higher muscular volume, and decreased values indicate worse outcomes from weaker muscular volume.
Time frame: Week15
Population: This measure estimates the treatment effect of acupuncture on knee function at the end of the acupuncture treatment time point in Week 15, in the between-groups A and C analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A Group in Week 15 | Circumference of L and R Upper Leg in Week 15 | L upper leg circumference | 55.3 centimeters | Standard Deviation 5.84 |
| A Group in Week 15 | Circumference of L and R Upper Leg in Week 15 | R upper leg circumference | 58.7 centimeters | Standard Deviation 6.88 |
| C Group in Week 15 | Circumference of L and R Upper Leg in Week 15 | L upper leg circumference | 58.3 centimeters | Standard Deviation 5.87 |
| C Group in Week 15 | Circumference of L and R Upper Leg in Week 15 | R upper leg circumference | 55.7 centimeters | Standard Deviation 9.25 |
Comparison: Circumference of the left (L) upper leg between groups analysis at Week 15. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessment.p-value: 0.083Wilcoxon (Mann-Whitney)
Comparison: Circumference of the right (R) upper leg between groups analysis at Week 15. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at specified assessments.p-value: 0.084Wilcoxon (Mann-Whitney)
Secondary
Circumference of L and R Upper Leg in Week 24
Circumference of the left (L) and right (R) upper leg in Week 24 is an objective measure, assessed by an independent physiatrist, at the thigh 15 centimetres above the patellar superior margin, measured with a tape measure. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents a measure of muscular strength or atrophy. Higher values indicate better outcomes from higher muscular volume, and decreased values indicate worse outcomes from weaker muscular volume.
Time frame: Week 24
Population: Circumference of L and R upper leg in Week 24 estimates the treatment effect of acupuncture on knee OA, nine weeks after the acupuncture treatment ended, analysed between groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A Group in Week 15 | Circumference of L and R Upper Leg in Week 24 | Circumference of L Upper Leg at Week 24 | 58.8 centimeters | Standard Deviation 5.59 |
| A Group in Week 15 | Circumference of L and R Upper Leg in Week 24 | Circumference of R Upper Leg at Week 24 | 59.3 centimeters | Standard Deviation 5.93 |
| C Group in Week 15 | Circumference of L and R Upper Leg in Week 24 | Circumference of L Upper Leg at Week 24 | 57.2 centimeters | Standard Deviation 6.61 |
| C Group in Week 15 | Circumference of L and R Upper Leg in Week 24 | Circumference of R Upper Leg at Week 24 | 57.2 centimeters | Standard Deviation 6.83 |
Comparison: Circumference of the left (L) upper leg between groups in Week 24. The Shapiro-Wilk test (S-W) was used to test the normality of a distribution. The comparability of groups regarding specified variables to accept or reject the hypothesis of groups comparability was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at assessments.p-value: 0.261Wilcoxon (Mann-Whitney)
Comparison: Circumference of the R upper leg between groups at Week 24. The Shapiro-Wilk test (S-W) was used to test the normality of distribution. The comparability of groups regarding specified variables (null hypothesis) was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at assessments.p-value: 0.273Wilcoxon (Mann-Whitney)
Secondary
DRUG by Added Assessment in Week 39, Crossover Part
DRUG is a measure that represents analgesics taken by participants, including various non-steroid anti-inflammatory drugs (NSAIDS) and/or tramadol. Recorded analgesics' doses from the last three days before assessment were recalculated in the comparable dose of the selective representative (ibuprofen) and converted into equivalent dose of milligrams of ibuprofen-ibuprofen equivalent units (IBU). DRUG's units of measure are IBU (units) on the scale ranging from 0 IBU to 4.500 IBU. DRUG decreasement represents a better therapeutic outcome, and an increase in DRUG represents a worse therapeutic outcome. All participants could self-manage the dosage according to their pain.
Time frame: Week 39
Population: DRUG in Week 39 estimates the treatment effect of acupuncture on knee OA pain at the end of acupuncture treatment, analysed within groups A and C to present the effects of the 24-week period after acupuncture ended in group A, and the immediate effects in group C.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | DRUG by Added Assessment in Week 39, Crossover Part | 276.1 milligrams-equivalent of ibuprofen(IBU) | Standard Deviation 566.46 |
| C Group in Week 15 | DRUG by Added Assessment in Week 39, Crossover Part | 319.6 milligrams-equivalent of ibuprofen(IBU) | Standard Deviation 473.08 |
| A Group in Week 0 | DRUG by Added Assessment in Week 39, Crossover Part | 637.5 milligrams-equivalent of ibuprofen(IBU) | Standard Deviation 1095.96 |
| C Group in Week 0 | DRUG by Added Assessment in Week 39, Crossover Part | 625.0 milligrams-equivalent of ibuprofen(IBU) | Standard Deviation 841.66 |
Comparison: The DRUG of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.p-value: 0.204Wilcoxon (Mann-Whitney)
Comparison: The DRUG of group C in Week 39 (when acupuncture of group C ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.p-value: 0.134Wilcoxon (Mann-Whitney)
Secondary
DRUG in Week 15
DRUG is a measure that represents analgesics taken by participants, including various non-steroid anti-inflammatory drugs (NSAIDS) and/or tramadol. Recorded analgesics' doses from the last three days before assessment were recalculated in the comparable dose of the selective representative (ibuprofen) and converted into equivalent dose of milligrams of ibuprofen-ibuprofen equivalent units (IBU). DRUG's units of measure are IBU (units) on the scale ranging from 0 IBU to 4.500 IBU. DRUG decreasement represents a better therapeutic outcome, and an increase in DRUG represents a worse therapeutic outcome. All participants could self-manage the dosage according to their pain.
Time frame: Week 15
Population: DRUG in Week 15 estimates the treatment effect of acupuncture on knee OA pain at the end of acupuncture treatment, analysed between groups A and C.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | DRUG in Week 15 | 96.0 milligrams-equivalent of ibuprofen(IBU) | Standard Deviation 183.7 |
| C Group in Week 15 | DRUG in Week 15 | 870.0 milligrams-equivalent of ibuprofen(IBU) | Standard Deviation 950.2 |
Comparison: In Week 15, DRUG was compared between groups. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
DRUG in Week 24
DRUG is a measure that represents analgesics taken by participants, including various non-steroid anti-inflammatory drugs (NSAIDS) and/or tramadol. Recorded analgesics' doses from the last three days before assessment were recalculated in the comparable dose of the selective representative (ibuprofen) and converted into equivalent dose of milligrams of ibuprofen-ibuprofen equivalent units (IBU). DRUG's units of measure are IBU (units) on the scale ranging from 0 IBU to 4.500 IBU. DRUG decreasement represents a better therapeutic outcome, and an increase in DRUG represents a worse therapeutic outcome. All participants could self-manage the dosage according to their pain.
Time frame: Week 24
Population: DRUG in Week 24 estimates the treatment effect of acupuncture on knee OA pain nine weeks after the end of acupuncture treatment, analysed between groups A and C.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | DRUG in Week 24 | 184.0 milligrams-equivalent of ibuprofen(IBU) | Standard Deviation 395 |
| C Group in Week 15 | DRUG in Week 24 | 765.5 milligrams-equivalent of ibuprofen(IBU) | Standard Deviation 783 |
Comparison: The DRUG between groups in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
KDSQ in Week 15
The Kidney Deficiency Syndrome Questionnaire (KDSQ) assesses the intensity of Kidney deficiency (KD) symptoms; the minimum value is 0, and the maximum is 69. A lower score/value represents a better outcome, and a higher score/value represents a worse outcome. This measure represents the effect of acupuncture treatment on KD.
Time frame: Week 15
Population: KDSQ in Week 15 estimates the treatment effect of acupuncture on Kidney deficiency symptoms at the end of the acupuncture treatments, analysed between the A and C groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | KDSQ in Week 15 | 10.8 score on a scale | Standard Deviation 6.7 |
| C Group in Week 15 | KDSQ in Week 15 | 24.8 score on a scale | Standard Deviation 12.5 |
Comparison: The Kidney Deficiency Syndrome Questionnaire (KDSQ) was compared between groups in Week 15. The Shapiro-Wilk test (S-W) tests the normality of data distribution. The comparability of groups regarding the null hypothesis of similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were used to analyse the statistical dispersion of specified sample data at specified assessment.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
KDSQ in Week 24
The Kidney Deficiency Syndrome Questionnaire (KDSQ) assesses the intensity of kidney deficiency symptoms; the minimum value is 0, and the maximum is 69. A lower score/value represents a better outcome, and a higher score/value represents a worse outcome. This measure represents the effect of acupuncture treatment on Kidney deficiency (KD).
Time frame: Week 24
Population: KDSQ in Week 24 estimates the treatment effect of acupuncture on KD symptoms 9 weeks after acupuncture treatment ended, analysed between groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | KDSQ in Week 24 | 13.9 score on a scale | Standard Deviation 8.9 |
| C Group in Week 15 | KDSQ in Week 24 | 25.0 score on a scale | Standard Deviation 12.4 |
Comparison: KDSQ between groups in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. The comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
KDSQ in Week 39
The Kidney Deficiency Syndrome Questionnaire (KDSQ) assesses the intensity of Kidney deficiency symptoms; the minimum value is 0, and the maximum is 69. A lower score/value represents a better outcome, and a higher score/value represents a worse outcome. This outcome represents the treatment effect of acupuncture on Kidney deficiency symptoms for both groups separately.
Time frame: Week 39
Population: KDSQ in Week 39 represents the treatment effect of acupuncture on Kidney deficiency symptoms intensity at the completed acupuncture treatments time point in group C and the magnitude of persisted effects 24 weeks after acupuncture treatments ended in group A, compared with Week 0 by within-group analysis separately for both groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | KDSQ in Week 39 | 14.6 score on a scale | Standard Deviation 9.12 |
| C Group in Week 15 | KDSQ in Week 39 | 14.8 score on a scale | Standard Deviation 8.92 |
| A Group in Week 0 | KDSQ in Week 39 | 27.2 score on a scale | Standard Deviation 11.1 |
| C Group in Week 0 | KDSQ in Week 39 | 26.2 score on a scale | Standard Deviation 11.89 |
Comparison: KDSQ of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: KDSQ of group C in Week 39 (when acupuncture of group C ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Lequesne Index in Week 24, Between-group Analysis
The Lequesne index is an algofunctional index of knee osteoarthritis that comprises three sections. Its score ranges from a minimal 0 (no pain and disability) to 24 (the greatest pain and disability). This index is added to the study in Week 24 as an additional objective measure. It measures pain severity with 5 questions, walking distance with 2 questions, and activities of daily living with 4 questions.
Time frame: Week 24
Population: Groups A and C were compared in Week 24 using a between-groups analysis to assess the effect of the acupuncture treatment on Group A, as Group C served as the control up to Week 24.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | Lequesne Index in Week 24, Between-group Analysis | 5.1 score on a scale | Standard Deviation 3.45 |
| C Group in Week 15 | Lequesne Index in Week 24, Between-group Analysis | 12.63 score on a scale | Standard Deviation 5.06 |
Comparison: The Lequesne index in Week 24 compared two confirmed comparable groups (at baseline), 9 weeks after acupuncture treatment in group A ended, while the C group was still a control. The Shapiro-Wilk test (S-W) tests normality distribution. The between-group comparability test at Week 24 was provided to accept or reject the null hypothesis by the Mann-Whitney U test, with 95 % power and a level of significance α = 0,05. Standard deviation (SD) was calculated to present the statistical dispersion.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
VAS in Week 15
Visual Analogue Scale (VAS) assesses knee OA pain intensity, ranging from 0 to 100; the lower value represents a better outcome, and the higher a worse outcome.
Time frame: Week 15
Population: VAS 15 measure estimates the treatment effect of acupuncture on KOA pain at the acupuncture treatment completion time point, analysed between the A and C groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | VAS in Week 15 | 12.6 score on a scale | Standard Deviation 12 |
| C Group in Week 15 | VAS in Week 15 | 61 score on a scale | Standard Deviation 19.5 |
Comparison: Visual Analogue Scale (VAS) was compared between groups at Week 15, when the acupuncture of group A ended. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) presented the statistical dispersion of sample data at specified assessments.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
VAS in Week 24
Visual Analogue Scale (VAS) assesses knee OA pain intensity, ranging from 0 to 100; the lower value represents a better outcome, and the higher a worse outcome.
Time frame: Week 24
Population: VAS in Week 24 estimates the treatment effect of acupuncture on knee pain, 9 weeks after acupuncture treatment ended, in between groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | VAS in Week 24 | 13.8 score on a scale | Standard Deviation 13.9 |
| C Group in Week 15 | VAS in Week 24 | 59.5 score on a scale | Standard Deviation 23.9 |
Comparison: VAS was compared between groups in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. The comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
VAS in Week 39
Visual Analogue Scale (VAS) assesses knee OA pain intensity, ranging from 0 to 100; the lower value represents a better outcome, and the higher a worse outcome. This measure estimates the treatment effect of acupuncture on knee pain in Week 39 separately for groups A and C.
Time frame: Week 39
Population: VAS in Week 39 presented two: group A was analysed for the magnitude of the persisted acupuncture effects 24 weeks after acupuncture ended, and the immediate acupuncture effect on knee pain was presented in group C.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | VAS in Week 39 | 18.3 score on a scale | Standard Deviation 22.59 |
| C Group in Week 15 | VAS in Week 39 | 28.0 score on a scale | Standard Deviation 21.36 |
| A Group in Week 0 | VAS in Week 39 | 59.5 score on a scale | Standard Deviation 22.77 |
| C Group in Week 0 | VAS in Week 39 | 59.1 score on a scale | Standard Deviation 18.1 |
Comparison: VAS of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: VAS of group C in Week 39 (when acupuncture of group C ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
WOMAC Functional Disability in Week 15
Western Ontario and McMaster University Osteoarthritis (WOMAC) functional disability subscale, separated from the WOMAC index, evaluates knee OA functional disability by participants' estimation. It comprises 17 items for functional disability assessment by a 5-point Likert scale ranging from minimal 0 to maximal 68 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC functional disability measures climbing, rising from a chair/bed, standing, bending, walking, getting in/out of a car/bath/toilet, shopping, putting on socks, sitting and difficulties in domestic duties.
Time frame: Week 15
Population: WOMAC functional disability in Week 15 estimates the immediate treatment effects of acupuncture on knee OA functional disability after acupuncture treatments were completed at Week 15 in a between-groups A and C analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | WOMAC Functional Disability in Week 15 | 8.6 score on a scale | Standard Deviation 8.8 |
| C Group in Week 15 | WOMAC Functional Disability in Week 15 | 38.6 score on a scale | Standard Deviation 13.9 |
Comparison: WOMAC functional disability between groups at Week 15. The Shapiro-Wilk test (S-W) tests normality distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the null hypothesis of equality was tested with the Mann-Whitney U test, with a power of 95 % and a level of significance α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at specified assessment (the mid-spread).p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
WOMAC Functional Disability in Week 24
Western Ontario and McMaster University Osteoarthritis (WOMAC) functional disability subscale, separated from the WOMAC index, evaluates knee OA functional disability by participants' estimation. It comprises 17 items of functional disability assessment by a 5-point Likert scale ranging from minimal 0 to maximal 68 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC functional disability measures climbing, rising from a chair/bed, standing, bending, walking, getting in/out of a car/bath/toilet, shopping, putting on socks, sitting, and difficulties in domestic duties.
Time frame: Week 24
Population: WOMAC functional disability in Week 24 estimates the effects of acupuncture on functional disability nine weeks after the acupuncture treatment of knee OA ended, using a between-groups A and C analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | WOMAC Functional Disability in Week 24 | 14.7 score on a scale | Standard Deviation 13.7 |
| C Group in Week 15 | WOMAC Functional Disability in Week 24 | 39.0 score on a scale | Standard Deviation 14.5 |
Comparison: WOMAC functional disability at Week 24 was analysed between groups. The Shapiro-Wilk test (S-W) tests the normality of data. The comparability of groups regarding specified variables (to accept or reject the null hypothesis of comparability) was tested with the Mann-Whitney U test with 95% power and a level of significance α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessments.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
WOMAC Functional Disability in Week 39
Western Ontario and McMaster University Osteoarthritis (WOMAC) functional disability subscale, separated from the WOMAC index, evaluates knee OA functional disability by participants' estimation. It comprises 17 items for functional disability assessment by a 5-point Likert scale ranging from minimal 0 to maximal 68 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC functional disability measures climbing, rising from a chair/bed, standing, bending, walking, getting in/out of a car/bath/toilet, shopping, putting on socks, sitting and difficulties in domestic duties.
Time frame: Week 39
Population: WOMAC functional disability in Week 39 represents the treatment effect of acupuncture on knee functional disability at the added assessment in Week 39 in the A and C groups compared to their baseline values by within-group analysis. It presents two: the magnitude of persisted effects 24 weeks after acupuncture treatment ended in group A, and the immediate effects of acupuncture treatment in group C in comparison with their baseline values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | WOMAC Functional Disability in Week 39 | 15.5 score on a scale | Standard Deviation 14.3 |
| C Group in Week 15 | WOMAC Functional Disability in Week 39 | 12.3 score on a scale | Standard Deviation 12.83 |
| A Group in Week 0 | WOMAC Functional Disability in Week 39 | 40.8 score on a scale | Standard Deviation 14.12 |
| C Group in Week 0 | WOMAC Functional Disability in Week 39 | 41.9 score on a scale | Standard Deviation 14.88 |
Comparison: The functional disability subscale of the WOMAC index of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: The functional disability subscale of the WOMAC index of group C in Week 39 (when acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
WOMAC Pain in Week 15
Western Ontario and McMaster University Osteoarthritis (WOMAC) pain subscale, separated from the WOMAC index, evaluates knee OA pain by participants. It comprises 5 questions for pain assessed by a 5-point Likert scale ranging from minimal 0 to maximal 20 points. A bigger score presents a worse outcome, and a lower score relates to a better outcome.
Time frame: Week 15
Population: WOMAC pain in Week 15 estimates the immediate treatment effects of acupuncture at Week 15 on knee OA pain after acupuncture treatments were completed in a between-groups A and C analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | WOMAC Pain in Week 15 | 2.4 score on a scale | Standard Deviation 2.4 |
| C Group in Week 15 | WOMAC Pain in Week 15 | 11.3 score on a scale | Standard Deviation 4.6 |
Comparison: WOMAC pain analysis between groups at Week 15. The Shapiro-Wilk test (S-W) was used for testing the normality of the data distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at assessments.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
WOMAC Pain in Week 24
Western Ontario and McMaster University Osteoarthritis (WOMAC) pain subscale, separated from the WOMAC index, evaluates OA pain by participants. It comprises 5 questions for pain assessed by a 5-point Likert scale, ranging from minimal 0 to maximal 20 points. A bigger score presents a worse outcome, and a lower score relates to a better one.
Time frame: Week 24
Population: WOMAC pain in Week 24, nine weeks after acupuncture treatment ended, was analysed between groups A and C.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | WOMAC Pain in Week 24 | 4.5 score on a scale | Standard Deviation 3.7 |
| C Group in Week 15 | WOMAC Pain in Week 24 | 11 score on a scale | Standard Deviation 4.6 |
Comparison: WOMAC pain was analysed between groups 9 weeks after acupuncture ended in Week 24. The Shapiro-Wilk test (S-W) tested the normality distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data (the mid-spread).p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
WOMAC Pain in Week 39
The Western Ontario and McMaster University Osteoarthritis (WOMAC) pain subscale, selected from the WOMAC index, evaluates knee OA pain by participants. It comprises 5 questions for pain assessed by a 5-point Likert scale, ranging from minimal 0 to maximal 20 points. A bigger score presents a worse outcome, and a lower score relates to a better one.
Time frame: Week 39
Population: WOMAC pain subscale in Week 39 by within-group analysis presented the magnitude of persisted pain reduction in group A (24 weeks after acupuncture treatment ended), and in group C, the immediate effects, when group C received acupuncture treatments after crossover in Week 25.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | WOMAC Pain in Week 39 | 5.3 score on a scale | Standard Deviation 4.72 |
| C Group in Week 15 | WOMAC Pain in Week 39 | 4.7 score on a scale | Standard Deviation 3.77 |
| A Group in Week 0 | WOMAC Pain in Week 39 | 11.5 score on a scale | Standard Deviation 4.61 |
| C Group in Week 0 | WOMAC Pain in Week 39 | 11.7 score on a scale | Standard Deviation 4.37 |
Comparison: The pain subscale of the WOMAC index of group A in Week 39 (24 weeks after acupunctures ended) was compared with baseline by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range and standard deviation were calculated to present the statistical dispersion of sample data at assessments.p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: The pain subscale of the WOMAC index of group C in Week 39 (end of acupuncture of group C) was compared with the pre-experimental baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range and standard deviation were calculated to present the statistical dispersion of data.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
WOMAC Stiffness in Week 15
Western Ontario and McMaster University Osteoarthritis (WOMAC) stiffness subscale, separated from the WOMAC index, and evaluate knee OA stiffness by participants. It comprises 2 questions for stiffness assessed by a 5-point Likert scale between the range from minimal 0 to maximal 8 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC stiffness measures the stiffness of the knees.
Time frame: Week 15
Population: WOMAC stiffness in Week 15 estimates the immediate treatment effects of acupuncture on knee OA stiffness after acupuncture treatments were completed at Week 15 in a between-groups A and C analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | WOMAC Stiffness in Week 15 | 0.7 score on a scale | Standard Deviation 0.9 |
| C Group in Week 15 | WOMAC Stiffness in Week 15 | 4.6 score on a scale | Standard Deviation 1.9 |
Comparison: WOMAC stiffness between groups at Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
WOMAC Stiffness in Week 24
Western Ontario and McMaster University Osteoarthritis (WOMAC) stiffness subscale, separated from the WOMAC index, evaluates knee OA stiffness by participants. It comprises 2 questions for stiffness assessed by a 5-point Likert scale ranging from minimal 0 to maximal 8 points. A bigger score represents a worse outcome, and a lower score relates to a better result. WOMAC stiffness measures the stiffness of the knees.
Time frame: Week 24
Population: WOMAC stiffness in Week 24, nine weeks after acupuncture treatment ended, was analysed between groups A and C.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | WOMAC Stiffness in Week 24 | 1.1 score on a scale | Standard Deviation 1.5 |
| C Group in Week 15 | WOMAC Stiffness in Week 24 | 3.4 score on a scale | Standard Deviation 2.2 |
Comparison: WOMAC stiffness between groups A and C in Week 24, 9 weeks after acupuncture ended. The Shapiro-Wilk test (S-W) tests the normality of distribution. Group comparability was tested with the Mann-Whitney U test with 95 % power and a level of significance α=0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessments.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
WOMAC Stiffness in Week 39
Western Ontario and McMaster University Osteoarthritis (WOMAC) stiffness subscale, separated from the WOMAC index, evaluates knee OA stiffness by participants. It comprises 2 questions for stiffness assessed by a 5-point Likert scale ranging from minimal 0 to maximal 8 points. A bigger score represents a worse outcome, and a lower score relates to a better result. WOMAC stiffness measures the stiffness of the knees.
Time frame: Week 39
Population: WOMAC stiffness in Week 39 presents in group A the magnitude of persisted acupuncture effects 24 weeks after acupuncture treatment ended, and in group C, the immediate effects of acupuncture after group C crossed over in Week 25, analysed within-groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | WOMAC Stiffness in Week 39 | 1.2 score on a scale | Standard Deviation 2.17 |
| C Group in Week 15 | WOMAC Stiffness in Week 39 | 1.2 score on a scale | Standard Deviation 1.95 |
| A Group in Week 0 | WOMAC Stiffness in Week 39 | 3.8 score on a scale | Standard Deviation 1.51 |
| C Group in Week 0 | WOMAC Stiffness in Week 39 | 4.2 score on a scale | Standard Deviation 2.2 |
Comparison: The stiffness subscale of the WOMAC index of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with the pre-experimental baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: The stiffness subscale of the WOMAC index of group C in Week 39 (end of acupuncture of group C) was compared with the pre-experimental baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range and standard deviation were calculated to present the statistical dispersion of data.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
WOMAC Total in Week 24
Western Ontario and McMaster University Osteoarthritis (WOMAC) index's total score is a sum of all three subscales for pain, stiffness, and functional disability, the minimum value is 0, and the maximum value is 96; the lower score/value represents a better outcome, and a higher score/value represents a worse outcome
Time frame: Week 24
Population: WOMAC total in Week 24 represents the treatment effect of acupuncture on pain, stiffness, and function at Assessment 9, in Week 24, nine weeks after acupuncture treatment ended, and was analysed between groups A and C.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | WOMAC Total in Week 24 | 20.4 score on a scale | Standard Deviation 18.4 |
| C Group in Week 15 | WOMAC Total in Week 24 | 53.4 score on a scale | Standard Deviation 20.5 |
Comparison: WOMAC total was analysed in Week 24 between groups, nine weeks after acupuncture ended. The Shapiro-Wilk test (S-W) tested the normality of the distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of equality was tested with the Mann-Whitney U test, with 95 % power and a level of significance α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessments.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
WOMAC Total in Week 39
Western Ontario and McMaster University Osteoarthritis (WOMAC) total at the Added assessment at Week 39 in the crossover part compared to pre-experimental baseline value. The total score is a sum of all three subscales: pain, stiffness, and functional limitation. The minimum value is 0, and the maximum value is 96, where the lower score/value represents a better outcome, and a higher score/value represents a worse outcome.
Time frame: Week 39
Population: WOMAC total in Week 39 represents the treatment effect of acupuncture on knee pain, stiffness, and function at the added assessment in Week 39 in the A and C groups compared to their baseline values by within-group analysis. It presents two: the magnitude of persisted effects 24 weeks after acupuncture treatment ended in group A, and the immediate effects of acupuncture treatment in group C in comparison with their baseline values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Group in Week 15 | WOMAC Total in Week 39 | 22.0 score on a scale | Standard Deviation 20.7 |
| C Group in Week 15 | WOMAC Total in Week 39 | 18.2 score on a scale | Standard Deviation 17.62 |
| A Group in Week 0 | WOMAC Total in Week 39 | 56.4 score on a scale | Standard Deviation 18.91 |
| C Group in Week 0 | WOMAC Total in Week 39 | 57.3 score on a scale | Standard Deviation 20.2 |
Comparison: Western Ontario and McMaster University Osteoarthritis Index (WOMAC) total of group A in Week 39 (24 weeks after acupunctures ended) was compared with the pre-experimental baseline assessment by within-group analysis. The Shapiro-Wilk test (S-W) tests normality distribution. The null hypothesis at weeks 0 and 39 was tested with the Mann-Whitney U test with 95 % power and a level of significance α=0,05. Standard deviation (SD) was calculated to present the statistical dispersion of the sample.p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: WOMAC total of group C in Week 39 was tested for the significance level and mean difference by within-group analysis. The Shapiro-Wilk test (S-W) tests normality distribution. WOMAC total at Week 0 (pre-experimental baseline assessment) and Week 39 were compared to test the null hypothesis of group comparability by the Mann-Whitney U test with 95 % power and a level of significance α=0,05. Standard deviation (SD) was calculated to present the statistical dispersion of a sample.p-value: <0.001Wilcoxon (Mann-Whitney)