Chronic Knee Pain
Conditions
Keywords
Chronic knee Pain, Pharmacopuncture
Brief summary
This study is a pragmatic randomized controlled trial. Condition/disease: Chronic Knee Pain. Intervention: Pharmacopuncture
Detailed description
Knee pain can have various causes. It may result from tears and injuries to structures or from inflammation due to various diseases. Chronic pain is often caused by overuse injuries, inflammation, or arthritis. Among these, osteoarthritis (OA) is the most common cause of chronic pain, affecting approximately 10% of Korean adults aged 20 to 89, either currently or in the past. In addition to OA, other conditions such as rheumatoid arthritis, post-traumatic degenerative arthritis, and chondromalacia can also lead to chronic pain. Therefore, it is evident that a significant number of patients suffer from chronic knee pain. The purpose of this study is to conduct a pragmatic randomized controlled clinical trial involving 40 patients suffering from chronic knee pain. The trial will compare the effects of treatment strategies utilizing pharmacopuncture (20 patients) with those utilizing the standard Western medical treatment of physical therapy (20 patients) to verify the comparative efficacy of pharmacopuncture. However, in this pragmatic clinical trial, patients will be randomly assigned to either the pharmacopuncture strategy or the physical therapy strategy. The specific methods of physical therapy and pharmacopuncture will not be predetermined but will be administered based on the clinical judgment of physicians and traditional Korean medicine practitioners according to the patient's condition. All applied treatment methods will be retrospectively reviewed through chart review and recorded in the Case Report Form (CRF) for comparison.
Interventions
PROCEDUREPharmacopuncture
The selection of acupoints, depth of insertion, and other parameters will be determined based on the clinical judgment of the Korean medicine practitioner, considering the patient's symptoms, imaging results, and degree of improvement. All acupoints where pharmacopuncture is administered will be recorded at the time of treatment. The type and dosage of pharmacopuncture solution to be used during treatment will be determined entirely based on the clinical judgment of the Korean medicine practitioner performing the pharmacopuncture. Retrospective chart reviews will be conducted to record the type of pharmacopuncture solution used and the total amount administered (in ml). The treatment will be administered twice a week for a total of 3 weeks, and all sessions will be documented for accurate evaluation.
PROCEDUREPhysical therapy
The selection of physical therapy methods, treatment areas, and treatment duration will be determined based on the clinical judgment of the physician, considering the patient's symptoms, imaging results, and degree of improvement. The type, frequency, and areas of prescribed and administered physical therapy will be recorded. The treatment will be administered twice a week for a total of 3 weeks, and all sessions will be documented for accurate evaluation.
Sponsors
Jaseng Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients whose NRS (Numeric Rating Scale) of knee pain is 5 or higher * Patients whose symptoms persist for more than 3 months * Patients who are between 19 and 70 years of age * Patients who, after receiving a detailed explanation of the clinical study and fully understanding it, voluntarily decide to participate and agree in writing to comply with the precautions.
Exclusion criteria
* Patients who have been diagnosed with a specific serious disease that may cause knee pain (acute fracture, dislocation, traumatic damage to ligaments and cartilage, etc.) * If the cause of the pain is caused by a disease other than the knee (tumor, fibromyalgia, rheumatoid arthritis, gout, lumbar disc herniation, etc.) * Cases that occur due to a traumatic event and require surgical intervention due to suspected acute fracture, dislocation, ligament and cartilage damage * Patients who diagnosed other chronic diseases (stroke, myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.) that may interfere with the treatment effect or interpretation of results. * Patients who are currently taking steroids, immunosuppressants, drugs for mental illness, or other drugs that may affect the results of the study * Patients who acupuncture treatment is inappropriate or unsafe: Patients with bleeding disorders, those receiving anticoagulant treatment, and patients with severe diabetes at risk of infection. * Patients who have taken drugs that may affect pain, such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), or have received herbal acupuncture or physical therapy within the past week * Patients who are pregnant, planning to become pregnant, or are breastfeeding * Patients within 3 months after knee surgery or if knee replacement surgery was performed * Patients who has been less than 1 month since you finished participating in another clinical study, or if you are planning to participate in another clinical study during the study participation and follow-up period within 6 months from the date of selection * Patients who difficult to fill out the consent form for research participation * Other cases where participation in clinical research is difficult in the judgment of the researcher.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Pain Numeric Rating Scale, NRS | Week 4 | Joint pain will be assessed using the NRS. In the NRS, the patient chooses a number from 0 to 10 that best describes how comfortably they can relax (0 being no pain and 10 being the most comfortable they can imagine). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Pain Visual Analogue Scale, VAS | Week 4 | Pain intensity will be assessed using the Visual Analog Scale (VAS). The VAS is a 100mm horizontal line with "no pain" at the left end (score 0) and "worst imaginable pain" at the right end (score 100). Higher scores indicate greater pain intensity. |
| Range of Motion, ROM | Week 4 | Passive ROM will be measured before and after treatment to evaluate changes before and after treatment. Passive ROM is evaluated by measuring the angle between the subject's lower extremity and an imaginary line drawn vertically from the ground at the maximum range of motion of the subject's knee joint in flexion, extension, left lateral flexion, and right lateral flexion. If measurement is not possible due to pain, it will be recorded as UC. |
| Korean Western Ontario & McMaster, K-WOMAC | Week 4 | K-WOMAC (Korean version of Western Ontario and McMaster Universities Osteoarthritis Index) was used to evaluate knee-related disability. It consists of 24 items across three subscales: Pain (5 items), Stiffness (2 items), and Physical Function (17 items). Each item is scored on a 5-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe, 4=extreme). The total score is calculated by summing the scores of all 24 items, ranging from 0 to 96. Higher scores indicate greater severity of symptoms and functional disability. |
| Short Form-12 Health Survey Version 2, SF-12 v2 | Week 4 | SF-12 v2 (Short Form-12 Health Survey version 2) was used to assess health-related quality of life (HRQoL). It consists of 12 items covering 8 domains. Individual item scores are transformed and weighted to produce two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The scores are norm-based, ranging from 0 to 100, where 50 represents the average score of the general population. Higher scores indicate better health-related quality of life. In this study, the \[PCS 또는 MCS 또는 Total score\] at Week 4 is reported. |
| EuroQol-5 Dimension, EQ-5D-5L | Week 4 | The EQ-5D-5L (EuroQol-5 Dimension 5-Level) was used to assess health-related quality of life. It consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels of severity. The responses were converted into a single index score using the South Korean value set. The EQ-5D-5L index scores range from -0.066 to 1.0, where 1.0 represents 'perfect health' and 0 represents 'death' (scores less than 0 represent states worse than death). A higher score indicates a better health-related quality of life. |
| Patient Global Impression of Change, PGIC | Week 4 | Patient global impression of change (PGIC) is a method that allows patients to subjectively evaluate the degree of improvement in 7 levels: 1, Very Much Improved; 2, Much Improved; 3, Minimally Improved; 4, No Change; 5, Minimally Worse; 6, Much Worse; or 7, Very Much Worse. |
| Credibility and Expectancy | Screening day(W-1) | To evaluate participants' expectations of treatment, a 9-point Likert scale is used. At the first visit, participants were asked, "How much do you think herbal acupuncture treatment and physical therapy will relieve your symptoms?" A score will be selected as an answer to the question (1 = not at all, 5 = somewhat, and 9 = very much). |
| Economic Evaluation Question-Medical Costs | Week 4 | To measure cost items, a separately developed questionnaire was used to measure formal/informal medical costs, non-medical costs, time costs, and productivity loss costs. Formal medical costs are the costs incurred in using the services of medical institutions, while unofficial costs such as purchasing health food and medical equipment are informal medical costs. Costs accompanying the use of medical services, such as transportation costs, patient time costs, and nursing care costs, are non-official costs. Applicable to medical expenses. The cost of productivity loss refers to the cost of economic loss resulting from the inability to participate in labor due to the disease itself or premature death due to the disease. To calculate the cost of productivity loss, a survey will be conducted using WPAI (the Work Productivity and Activity Impairment questionnaire), which will be converted into costs and used for cost-utility analysis. |
| Economic Evaluation Question-Time Cost | Week 2 | To measure cost items, a separately developed questionnaire was used to measure formal/informal medical costs, non-medical costs, time costs, and productivity loss costs. Formal medical costs are the costs incurred in using the services of medical institutions, while unofficial costs such as purchasing health food and medical equipment are informal medical costs. Costs accompanying the use of medical services, such as transportation costs, patient time costs, and nursing care costs, are non-official costs. Applicable to medical expenses. The cost of productivity loss refers to the cost of economic loss resulting from the inability to participate in labor due to the disease itself or premature death due to the disease. To calculate the cost of productivity loss, a survey will be conducted using WPAI (the Work Productivity and Activity Impairment questionnaire), which will be converted into costs and used for cost-utility analysis. |
| Economic Evaluation Question-Productivity Loss | Week 4 | To measure cost items, a separately developed questionnaire was used to measure formal/informal medical costs, non-medical costs, time costs, and productivity loss costs. Formal medical costs are the costs incurred in using the services of medical institutions, while unofficial costs such as purchasing health food and medical equipment are informal medical costs. Costs accompanying the use of medical services, such as transportation costs, patient time costs, and nursing care costs, are non-official costs. Applicable to medical expenses. The cost of productivity loss refers to the cost of economic loss resulting from the inability to participate in labor due to the disease itself or premature death due to the disease. To calculate the cost of productivity loss, a survey will be conducted using WPAI (the Work Productivity and Activity Impairment questionnaire), which will be converted into costs and used for cost-utility analysis. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORSunah Kim, KMD
Daejeon Jaseng Hospital of Korean Medicine
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 44 years |
| Credibility and Expectancy | 8 scores on a scale STANDARD_DEVIATION 0 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| EuroQol-5 Dimension, EQ-5D-5L | 0.73 scores on a scale STANDARD_DEVIATION 0.03 |
| Knee pain numeric rating scale, NRS | 6.12 scores on a scale STANDARD_DEVIATION 0.29 |
| Knee pain visual analogue scale, VAS | 59.18 scores on a scale STANDARD_DEVIATION 3.56 |
| Korean Western Ontario & McMaster, K-WOMAC | 59.31 scores on a scale STANDARD_DEVIATION 13.45 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Range of motion, ROM extension | 0.2 degrees STANDARD_DEVIATION 0 |
| Range of motion, ROM flexion | 135 degrees STANDARD_DEVIATION 0 |
| Range of motion, ROM left lateral flexion | 5 degrees STANDARD_DEVIATION 0 |
| Range of motion, ROM right lateral flexion | 5 degrees STANDARD_DEVIATION 0 |
| Region of Enrollment South Korea | 15 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
| Short Form-12 Health Survey version 2, SF-12 v2 | 41.57 scores on a scale STANDARD_DEVIATION 42.03 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
None listed