Low Back Pain
Conditions
Keywords
treatment, acupuncture, spine
Brief summary
The aim of the present study is to assess the effectiveness of acupuncture using Yamamoto's method for the treatment of ANLBP using the following outcomes:pain,functional capacity,quality of life and number of 50 mg sodium diclofenac pills taken per day.
Detailed description
A randomized, controlled, double-blind, prospective trial is being conducted involving 80 patients with low-back pain defined as pain and discomfort localised bellow the costal margin and above the inferior gluteal folds, for a period of less than 30 days and unrelated to any specific etiological factors. Patients are being recruited from the university hospital of the Federal University of Sao Paul (UNIFESP)and exams were carried out by a rheumatologist. The patients are randomly assigned to either intervention group (IG) and are submitted to five acupuncture sessions or placebo group (PG) and are submitted to five non-penetrating acupuncture sessions. Both groups are recommended to take 50 mg of sodium diclofenac every eight hours for lumbar pain, if needed and record the number of pills on a standardized form. The patients are instructed not to use other medications or therapies for low-back pain during the study.The IG are submitted to acupuncture by a physician acupuncturist with eight years experience in the technique. Five acupuncture session are performed at baseline, D3, D7, D14 and D21. Specific needles for scalp acupuncture and tubes that guide these needles, called mandrels are unpacked in front of the patient. The stainless steel needles: 0.20 x 13 mm, sterilized and disposable.Sessions last 20 minutes. The patient remain seated, using a hat with a central orifice exposing the area to receive the needles. The hat has a wide brim to keep the patient blinded for the procedures. The needle penetrates the skin at an approximately 15º angle and a depth of 0.3 to 0.5 cm. The PG are submitted to five placebo acupuncture session performed by the same acupuncturist with same material and hat, but penetration did not occur and only the mandrel came into contact with the skin. All patients are blind to which procedure they are receiving. The basic points D, H and I and kidney, bladder and liver points of Yamamoto's method are used as standard treatment to ANLBP for the both groups. Evaluations: The IG and PG are evaluated six times between baseline and Day 28 immediately before and after each acupuncture session. Outcome measures are recorded by a single assessor blinded to group allocation. D0: baseline; D3: three days after baseline; D7: seven days after baseline; D14: fourteen days after baseline; D21: twenty-one days after baseline and D28: twenty-eight days after baseline. Losses: Participants absent from more than three acupuncture sessions and evaluations are considered losses. Placebo credibility: At the end of the study, participants are asked about which group they believed they belonged. Sample size: To achieve an improvement in VAS pain of 2.0 point, with a significance of 0.05, and a power of 0.90, a minimum of 40 patients per group is necessary as a previous compensation for the possible 20% loss at follow-up. Statistics: An intention-to-treat analysis are performed, using the last-observation-carried-forward method. A level of significance of p \< 0.05 (2-tailed tests) are accepted for the trial. For normally distributed data, the variables are analysed using repeated-measures analysis of variance (ANOVA). The analysis are performed between groups (acupuncture versus non-penetrating acupuncture; between subjects factors) and over the time (baseline, 3, 7, 14, 21 and 28 days; within subjects factors). Categorical data measured over time are analysed using repeated-measures analyses of variance (ANOVA) for categorical data. A 95% confidence interval (95% CI) are used. The Student's t-test are used to compare numerical variables with normal distribution at one time and the chi-square test or Fisher's exact test are used to determine differences in rates of improvement between the two groups. The Kappa index are used to determine agreement on the LIKERT assessment between patient and assessor. All tests are performed using SPSS version 15.0 and MINITAB 14.0
Interventions
OTHERAcupuncture
The intervention group (IG) are submitted to five acupuncture sessions using Yamamoto New Scalp Acupuncture(YNSA)
OTHERNon-penetrating acupuncture
The placebo group (PG) are submitted to five non-penetrating acupuncture sessions using YNSA.
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female * Aged 18 to 65 years * Seeking medical assistance for nonspecific low-back pain * Score of 4 to 8 cm on the pain scale (0 to 10 cm) * Agreed to participate and signed term of informed consent
Exclusion criteria
* Patients with a diagnostic investigation of secondary causes as spondyloarthropathy, infection, tumor or fracture * Sciatica lumbar pain * Previous surgery on spinal column * Litigation * Having changed physical activity or underwent acupuncture or physical therapy in previous three months, * Having previously undergone scalp acupuncture * Pregnancy * Contraindication for anti-inflammatory agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Assessed on a 10-point Numeric Pain Scale | days 0, 3, 7, 14, 21 and 28 | The primary outcome is a visual analog pain scale (VAS), graded in centimeters from 0 to 10 (0=no pain; 10=worst imaginable pain), measured before (VAS 1) and after (VAS 2) the acupuncture session. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Roland-Morris Disability Questionnaire (RM) | days 0, 3, 7, 14, 21 and 28 | Secondary outcomes includes the Roland-Morris Disability Questionnaire (RM) for the assessment of functional capacity, with 24 items on low-back pain: higher scores denote poorer functional capacity. 0: better functional capacity 24: poorer functional capacity Range of score: the highest is 24 (poorer functional capacity) and lowest scores is 0 (better functional capacity). |
| Quality of Life Assessed on the SF-36 | Days 0, 3, 7, 14, 21 and 28 | Questionnaire Short-form-36 is a widely used generic health status questionnaire, validated for Portuguese with eight components and each components with scores from 0 to 100: higher scores denote greater quality of life. |
| Likert Improvement Assessment Scale | Days 0, 3, 7, 14 and 21 | Likert improvement assessment scale is based on the patient's opinion (LIKERT P) and assessor's opinion (LIKERT A), categorized in 1=MB (much better), 2=SB (slightly better), 3=NC (no change), 4=SW (slightly worse) and 5=MW (much worse). This scale was was applied to each day of assessment. The numbers in the category titles represent the different days. |
| Number of Anti-inflammatory Tablets Taken | Days 3,7,14,21 and 28 | Number of 50 mg sodium diclofenac pills taken per day |
Countries
Brazil
Participant flow
Recruitment details
100 patients were recruited from the university hospital of the Federal University of São Paul (UNIFESP), from November 2009 to June 2010.
Pre-assignment details
80 patients were randomized during the study.
Participants by arm
| Arm | Count |
|---|---|
| Acupuncture The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA. | 40 |
| Placebo Group Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG). | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Acupuncture | Placebo Group | Total |
|---|---|---|---|
| Age, Categorical Between 18 and 65 years | 40 Participants | 40 Participants | 80 Participants |
| Age Continuous | 47 years STANDARD_DEVIATION 9.8 | 43.9 years STANDARD_DEVIATION 10.9 | 45.4 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment Brazil | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 25 Participants | 26 Participants | 51 Participants |
| Sex: Female, Male Male | 15 Participants | 14 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Pain Assessed on a 10-point Numeric Pain Scale
The primary outcome is a visual analog pain scale (VAS), graded in centimeters from 0 to 10 (0=no pain; 10=worst imaginable pain), measured before (VAS 1) and after (VAS 2) the acupuncture session.
Time frame: days 0, 3, 7, 14, 21 and 28
Population: Intention to treat analysis (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acupuncture | Pain Assessed on a 10-point Numeric Pain Scale | Day 0 | 6.55 cm | Standard Deviation 1.4 |
| Acupuncture | Pain Assessed on a 10-point Numeric Pain Scale | Day 3 | 4.63 cm | Standard Deviation 2.23 |
| Acupuncture | Pain Assessed on a 10-point Numeric Pain Scale | Day 7 | 3.83 cm | Standard Deviation 2.61 |
| Acupuncture | Pain Assessed on a 10-point Numeric Pain Scale | Day 14 | 2.8 cm | Standard Deviation 2.27 |
| Acupuncture | Pain Assessed on a 10-point Numeric Pain Scale | Day 21 | 2.49 cm | Standard Deviation 2.4 |
| Acupuncture | Pain Assessed on a 10-point Numeric Pain Scale | Day 28 | 1.98 cm | Standard Deviation 2.12 |
| Placebo Group | Pain Assessed on a 10-point Numeric Pain Scale | Day 21 | 4.18 cm | Standard Deviation 2.52 |
| Placebo Group | Pain Assessed on a 10-point Numeric Pain Scale | Day 0 | 6.68 cm | Standard Deviation 1.44 |
| Placebo Group | Pain Assessed on a 10-point Numeric Pain Scale | Day 14 | 3.95 cm | Standard Deviation 2.19 |
| Placebo Group | Pain Assessed on a 10-point Numeric Pain Scale | Day 3 | 5.13 cm | Standard Deviation 2.21 |
| Placebo Group | Pain Assessed on a 10-point Numeric Pain Scale | Day 28 | 3.38 cm | Standard Deviation 2.26 |
| Placebo Group | Pain Assessed on a 10-point Numeric Pain Scale | Day 7 | 4.4 cm | Standard Deviation 2.09 |
Secondary
Likert Improvement Assessment Scale
Likert improvement assessment scale is based on the patient's opinion (LIKERT P) and assessor's opinion (LIKERT A), categorized in 1=MB (much better), 2=SB (slightly better), 3=NC (no change), 4=SW (slightly worse) and 5=MW (much worse). This scale was was applied to each day of assessment. The numbers in the category titles represent the different days.
Time frame: Days 0, 3, 7, 14 and 21
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acupuncture | Likert Improvement Assessment Scale | Likert 0 P | 1.6 scores on a scale | Standard Deviation 0.54 |
| Acupuncture | Likert Improvement Assessment Scale | Likert 0 A | 1.6 scores on a scale | Standard Deviation 0.63 |
| Acupuncture | Likert Improvement Assessment Scale | Likert 3 P | 1.67 scores on a scale | Standard Deviation 0.72 |
| Acupuncture | Likert Improvement Assessment Scale | Likert 3 A | 1.62 scores on a scale | Standard Deviation 0.66 |
| Acupuncture | Likert Improvement Assessment Scale | Likert 7 P | 1.67 scores on a scale | Standard Deviation 0.72 |
| Acupuncture | Likert Improvement Assessment Scale | Likert 7 A | 1.55 scores on a scale | Standard Deviation 0.67 |
| Acupuncture | Likert Improvement Assessment Scale | Likert 14 P | 1.77 scores on a scale | Standard Deviation 0.73 |
| Acupuncture | Likert Improvement Assessment Scale | Likert 14 A | 1.65 scores on a scale | Standard Deviation 0.73 |
| Acupuncture | Likert Improvement Assessment Scale | Likert 21 P | 1.65 scores on a scale | Standard Deviation 0.8 |
| Acupuncture | Likert Improvement Assessment Scale | Likert 21 A | 1.62 scores on a scale | Standard Deviation 0.8 |
| Placebo Group | Likert Improvement Assessment Scale | Likert 14 A | 2.12 scores on a scale | Standard Deviation 0.82 |
| Placebo Group | Likert Improvement Assessment Scale | Likert 0 P | 2.15 scores on a scale | Standard Deviation 0.66 |
| Placebo Group | Likert Improvement Assessment Scale | Likert 7 A | 2.07 scores on a scale | Standard Deviation 0.91 |
| Placebo Group | Likert Improvement Assessment Scale | Likert 0 A | 2.0 scores on a scale | Standard Deviation 0.78 |
| Placebo Group | Likert Improvement Assessment Scale | Likert 21 A | 1.95 scores on a scale | Standard Deviation 0.81 |
| Placebo Group | Likert Improvement Assessment Scale | Likert 3 P | 2.27 scores on a scale | Standard Deviation 0.71 |
| Placebo Group | Likert Improvement Assessment Scale | Likert 14 P | 2.05 scores on a scale | Standard Deviation 0.71 |
| Placebo Group | Likert Improvement Assessment Scale | Likert 3 A | 2.17 scores on a scale | Standard Deviation 0.81 |
| Placebo Group | Likert Improvement Assessment Scale | Likert 21 P | 2.07 scores on a scale | Standard Deviation 0.88 |
| Placebo Group | Likert Improvement Assessment Scale | Likert 7 P | 2.20 scores on a scale | Standard Deviation 0.79 |
Secondary
Number of Anti-inflammatory Tablets Taken
Number of 50 mg sodium diclofenac pills taken per day
Time frame: Days 3,7,14,21 and 28
Population: Intention to treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acupuncture | Number of Anti-inflammatory Tablets Taken | Day 7 | 1.9 number of pills/day | Standard Deviation 3.6 |
| Acupuncture | Number of Anti-inflammatory Tablets Taken | Day 21 | 1.2 number of pills/day | Standard Deviation 2.8 |
| Acupuncture | Number of Anti-inflammatory Tablets Taken | Day 14 | 1.3 number of pills/day | Standard Deviation 3.1 |
| Acupuncture | Number of Anti-inflammatory Tablets Taken | Day 28 | 1.1 number of pills/day | Standard Deviation 2.7 |
| Acupuncture | Number of Anti-inflammatory Tablets Taken | Day 3 | 1.5 number of pills/day | Standard Deviation 2.6 |
| Placebo Group | Number of Anti-inflammatory Tablets Taken | Day 28 | 2.3 number of pills/day | Standard Deviation 3.9 |
| Placebo Group | Number of Anti-inflammatory Tablets Taken | Day 3 | 2.6 number of pills/day | Standard Deviation 2.8 |
| Placebo Group | Number of Anti-inflammatory Tablets Taken | Day 7 | 4.2 number of pills/day | Standard Deviation 4.7 |
| Placebo Group | Number of Anti-inflammatory Tablets Taken | Day 14 | 3.3 number of pills/day | Standard Deviation 6 |
| Placebo Group | Number of Anti-inflammatory Tablets Taken | Day 21 | 3.7 number of pills/day | Standard Deviation 5.2 |
Secondary
Quality of Life Assessed on the SF-36
Questionnaire Short-form-36 is a widely used generic health status questionnaire, validated for Portuguese with eight components and each components with scores from 0 to 100: higher scores denote greater quality of life.
Time frame: Days 0, 3, 7, 14, 21 and 28
Population: Intention to treat analysis (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 0 Pain | 27.6 scores on a scale | Standard Deviation 17.9 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 3 Functional Capacity | 58.5 scores on a scale | Standard Deviation 25.7 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 7 Functional Capacity | 68.8 scores on a scale | Standard Deviation 22.3 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 14 Functional Capacity | 78.6 scores on a scale | Standard Deviation 20.8 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 21 Functional Capacity | 81.8 scores on a scale | Standard Deviation 17.6 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 28 Functional Capacity | 84.0 scores on a scale | Standard Deviation 19.8 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 0 limitation in physical aspects | 18.1 scores on a scale | Standard Deviation 26.5 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 3 limitation in physical aspects | 35.6 scores on a scale | Standard Deviation 37.9 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 7 limitation in physical aspects | 53.1 scores on a scale | Standard Deviation 39.7 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 14 limitation in physical aspects | 70.6 scores on a scale | Standard Deviation 36.2 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 21 limitation in physical aspects | 75.6 scores on a scale | Standard Deviation 33.7 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 28 limitation in physical aspects | 78.8 scores on a scale | Standard Deviation 31.8 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 0 Functional Capacity | 46.4 scores on a scale | Standard Deviation 22.7 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 3 Pain | 46.1 scores on a scale | Standard Deviation 24.9 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 7 Pain | 54.8 scores on a scale | Standard Deviation 20 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 14 Pain | 64.9 scores on a scale | Standard Deviation 20.3 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 21 Pain | 69.3 scores on a scale | Standard Deviation 22.7 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 28 Pain | 67.8 scores on a scale | Standard Deviation 26.1 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 0 General Health State | 54.2 scores on a scale | Standard Deviation 25.7 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 3 General Health State | 60.5 scores on a scale | Standard Deviation 23 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 7 General Health State | 59.6 scores on a scale | Standard Deviation 25.9 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 14 General Health State | 66.6 scores on a scale | Standard Deviation 20.9 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 21 General Health State | 66.7 scores on a scale | Standard Deviation 22.2 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 28 General Health State | 69.0 scores on a scale | Standard Deviation 22.9 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 0 Vitality | 49.4 scores on a scale | Standard Deviation 25.3 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 3 Vitality | 56.4 scores on a scale | Standard Deviation 24.3 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 7 Vitality | 60.9 scores on a scale | Standard Deviation 23.1 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 14 Vitality | 69.3 scores on a scale | Standard Deviation 19.4 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 21 Vitality | 68.2 scores on a scale | Standard Deviation 20.4 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 28 Vitality | 69.6 scores on a scale | Standard Deviation 23.2 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 0 Social Aspects | 62.5 scores on a scale | Standard Deviation 34.6 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 3 Social Aspects | 76.9 scores on a scale | Standard Deviation 27.7 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 7 Social Aspects | 80.3 scores on a scale | Standard Deviation 27.9 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 14 Social Aspects | 89.4 scores on a scale | Standard Deviation 17.8 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 21 Social Aspects | 90.9 scores on a scale | Standard Deviation 17 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 28 Social Aspects | 89.7 scores on a scale | Standard Deviation 17.4 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 0 Emotional Aspects | 57.5 scores on a scale | Standard Deviation 41.3 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 3 Emotional Aspects | 73.3 scores on a scale | Standard Deviation 37.1 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 7 Emotional Aspects | 80.0 scores on a scale | Standard Deviation 33.6 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 14 Emotional Aspects | 84.2 scores on a scale | Standard Deviation 32 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 21 Emotional Aspects | 87.5 scores on a scale | Standard Deviation 24.7 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 28 Emotional Aspects | 81.7 scores on a scale | Standard Deviation 30.1 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 0 Mental Health | 54.3 scores on a scale | Standard Deviation 22 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 3 Mental Health | 63.1 scores on a scale | Standard Deviation 22.8 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 7 Mental Health | 67.4 scores on a scale | Standard Deviation 19.2 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 14 Mental Health | 68.5 scores on a scale | Standard Deviation 19.5 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 21 Mental Health | 69.3 scores on a scale | Standard Deviation 20.6 |
| Acupuncture | Quality of Life Assessed on the SF-36 | Day 28 Mental Health | 66.4 scores on a scale | Standard Deviation 22.5 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 21 Mental Health | 63.7 scores on a scale | Standard Deviation 25.2 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 0 Functional Capacity | 55.8 scores on a scale | Standard Deviation 19.2 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 0 Vitality | 47.6 scores on a scale | Standard Deviation 17.3 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 3 Functional Capacity | 60.6 scores on a scale | Standard Deviation 19.6 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 0 Emotional Aspects | 62.5 scores on a scale | Standard Deviation 40.1 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 7 Functional Capacity | 66.6 scores on a scale | Standard Deviation 17.1 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 3 Vitality | 54.3 scores on a scale | Standard Deviation 20 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 14 Functional Capacity | 71.6 scores on a scale | Standard Deviation 20.8 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 0 Mental Health | 58.5 scores on a scale | Standard Deviation 19.7 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 21 Functional Capacity | 71.4 scores on a scale | Standard Deviation 21.7 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 7 Vitality | 57.1 scores on a scale | Standard Deviation 22.3 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 28 Functional Capacity | 70.9 scores on a scale | Standard Deviation 22.5 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 3 Emotional Aspects | 71.7 scores on a scale | Standard Deviation 40.3 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 0 limitation in physical aspects | 16.3 scores on a scale | Standard Deviation 26.3 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 14 Vitality | 52.8 scores on a scale | Standard Deviation 24.1 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 3 limitation in physical aspects | 30.6 scores on a scale | Standard Deviation 33.2 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 14 Mental Health | 65.1 scores on a scale | Standard Deviation 21.3 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 7 limitation in physical aspects | 43.8 scores on a scale | Standard Deviation 40.7 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 21 Vitality | 56.3 scores on a scale | Standard Deviation 25.5 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 14 limitation in physical aspects | 55.0 scores on a scale | Standard Deviation 35 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 7 Emotional Aspects | 78.3 scores on a scale | Standard Deviation 38.2 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 21 limitation in physical aspects | 56.3 scores on a scale | Standard Deviation 39.9 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 28 Vitality | 58.8 scores on a scale | Standard Deviation 24 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 28 limitation in physical aspects | 55.8 scores on a scale | Standard Deviation 38.3 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 3 Mental Health | 62.9 scores on a scale | Standard Deviation 21.3 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 0 Pain | 28.8 scores on a scale | Standard Deviation 19.1 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 0 Social Aspects | 65.9 scores on a scale | Standard Deviation 32.3 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 3 Pain | 44.8 scores on a scale | Standard Deviation 19.4 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 14 Emotional Aspects | 80.0 scores on a scale | Standard Deviation 30.9 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 7 Pain | 51.5 scores on a scale | Standard Deviation 21.4 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 3 Social Aspects | 75.6 scores on a scale | Standard Deviation 29.7 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 14 Pain | 53.6 scores on a scale | Standard Deviation 19.2 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 28 Mental Health | 65.2 scores on a scale | Standard Deviation 22.8 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 21 Pain | 54.6 scores on a scale | Standard Deviation 24.7 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 7 Social Aspects | 80.9 scores on a scale | Standard Deviation 29.6 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 28 Pain | 56.5 scores on a scale | Standard Deviation 23.4 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 21 Emotional Aspects | 73.3 scores on a scale | Standard Deviation 37.1 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 0 General Health State | 56.5 scores on a scale | Standard Deviation 24.9 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 14 Social Aspects | 76.6 scores on a scale | Standard Deviation 31.9 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 3 General Health State | 62.0 scores on a scale | Standard Deviation 22.4 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 7 Mental Health | 66.3 scores on a scale | Standard Deviation 21 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 7 General Health State | 63.7 scores on a scale | Standard Deviation 23.1 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 21 Social Aspects | 79.4 scores on a scale | Standard Deviation 28.9 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 14 General Health State | 60.4 scores on a scale | Standard Deviation 23.3 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 28 Emotional Aspects | 76.7 scores on a scale | Standard Deviation 36.4 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 21 General Health State | 58.4 scores on a scale | Standard Deviation 23.1 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 28 Social Aspects | 82.5 scores on a scale | Standard Deviation 25.9 |
| Placebo Group | Quality of Life Assessed on the SF-36 | Day 28 General Health State | 63.4 scores on a scale | Standard Deviation 22.6 |
Secondary
Roland-Morris Disability Questionnaire (RM)
Secondary outcomes includes the Roland-Morris Disability Questionnaire (RM) for the assessment of functional capacity, with 24 items on low-back pain: higher scores denote poorer functional capacity. 0: better functional capacity 24: poorer functional capacity Range of score: the highest is 24 (poorer functional capacity) and lowest scores is 0 (better functional capacity).
Time frame: days 0, 3, 7, 14, 21 and 28
Population: Intention to treat analysis (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acupuncture | Roland-Morris Disability Questionnaire (RM) | Day 0 | 14.9 scores on a scale | Standard Deviation 4 |
| Acupuncture | Roland-Morris Disability Questionnaire (RM) | Day 3 | 10.3 scores on a scale | Standard Deviation 5.4 |
| Acupuncture | Roland-Morris Disability Questionnaire (RM) | Day 7 | 8.1 scores on a scale | Standard Deviation 5.5 |
| Acupuncture | Roland-Morris Disability Questionnaire (RM) | Day14 | 5.3 scores on a scale | Standard Deviation 4.6 |
| Acupuncture | Roland-Morris Disability Questionnaire (RM) | Day 21 | 4.40 scores on a scale | Standard Deviation 4.4 |
| Acupuncture | Roland-Morris Disability Questionnaire (RM) | Day 28 | 4.1 scores on a scale | Standard Deviation 4.7 |
| Placebo Group | Roland-Morris Disability Questionnaire (RM) | Day 21 | 8.5 scores on a scale | Standard Deviation 6.2 |
| Placebo Group | Roland-Morris Disability Questionnaire (RM) | Day 0 | 14.6 scores on a scale | Standard Deviation 4.8 |
| Placebo Group | Roland-Morris Disability Questionnaire (RM) | Day14 | 8.9 scores on a scale | Standard Deviation 5.2 |
| Placebo Group | Roland-Morris Disability Questionnaire (RM) | Day 3 | 12.4 scores on a scale | Standard Deviation 4.5 |
| Placebo Group | Roland-Morris Disability Questionnaire (RM) | Day 28 | 8.0 scores on a scale | Standard Deviation 6.1 |
| Placebo Group | Roland-Morris Disability Questionnaire (RM) | Day 7 | 10.2 scores on a scale | Standard Deviation 5.3 |
p-value: ,0ANOVA