An interventional study of Pharmacopuncture and Physical therapy in Chronic Knee Pain, sponsored by Jaseng Medical Foundation. Completed at 1 site in South Korea. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Jaseng Medical Foundation · Not applicable, Interventional, and Treatment
This study is a pragmatic randomized controlled trial. Condition/disease: Chronic Knee Pain. Intervention: Pharmacopuncture
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.
Jaseng Medical Foundation is the lead sponsor of 67 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
20 patients with pharmacoacupuncture
Procedure: Pharmacopuncture
20 patients with physical therapy
Procedure: Physical therapy
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.
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.
Knee Pain Numeric Rating Scale, NRS
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).
Time frame: Week 4
Knee Pain Visual Analogue Scale, VAS
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.
Time frame: Week 4
Range of Motion, ROM
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.
Time frame: Week 4
Korean Western Ontario & McMaster, K-WOMAC
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.
Time frame: Week 4
Short Form-12 Health Survey Version 2, SF-12 v2
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.
Time frame: Week 4
EuroQol-5 Dimension, EQ-5D-5L
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.
Time frame: Week 4
Patient Global Impression of Change, PGIC
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.
Time frame: Week 4
Credibility and Expectancy
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).
Time frame: Screening day(W-1)
Economic Evaluation Question-Medical Costs
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.
Time frame: Week 4
Economic Evaluation Question-Time Cost
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.
Time frame: Week 2
Economic Evaluation Question-Productivity Loss
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.
Time frame: Week 4
| Milestone | Pharmacopuncture | Physical Therapy |
|---|---|---|
| Started | 15 | 15 |
| Completed | 15 | 15 |
| Not completed | 0 | 0 |
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).
| scores on a scale | Pharmacopuncture | Physical Therapy |
|---|---|---|
| Knee Pain Numeric Rating Scale, NRS | 3.15 ± 2.05 | 5.20 ± 2.05 |
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.
| scores on a scale | Pharmacopuncture | Physical Therapy |
|---|---|---|
| Knee Pain Visual Analogue Scale, VAS | 30.63 ± 21.58 | 52.22 ± 21.58 |
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.
| degrees | Pharmacopuncture | Physical Therapy |
|---|---|---|
| flexion | 135 ± 0 | 135 ± 0 |
| extension | 0 ± 0 | 0 ± 0 |
| right lateral flexion | 5 ± 0 | 5 ± 0 |
| left lateral flexion | 5 ± 0 | 5 ± 0 |
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.
| scores on a scale | Pharmacopuncture | Physical Therapy |
|---|---|---|
| Korean Western Ontario & McMaster, K-WOMAC | 43.02 ± 13.17 | 56.18 ± 13.17 |
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.
| scores on a scale | Pharmacopuncture | Physical Therapy |
|---|---|---|
| Short Form-12 Health Survey Version 2, SF-12 v2 | 53.27 ± 1.39 | 51.89 ± 1.39 |
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.
| scores on a scale | Pharmacopuncture | Physical Therapy |
|---|---|---|
| EuroQol-5 Dimension, EQ-5D-5L | 0.81 ± 0.03 | 0.78 ± 0.03 |
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.
| scores on a scale | Pharmacopuncture | Physical Therapy |
|---|---|---|
| Patient Global Impression of Change, PGIC | 2 ± 0 | 3 ± 0 |
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).
| scores on a scale | Pharmacopuncture | Physical Therapy |
|---|---|---|
| Credibility and Expectancy | 8 ± 0 | 7 ± 0 |
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.
| South Korean Won (KRW) | Pharmacopuncture | Physical Therapy |
|---|---|---|
| Economic Evaluation Question-Medical Costs | 500,000 ± 150,000 | 400,000 ± 100,000 |
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.
| South Korean Won (KRW) | Pharmacopuncture | Physical Therapy |
|---|---|---|
| Economic Evaluation Question-Time Cost | 120,000 ± 30,000 | 110,000 ± 20,000 |
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.
| South Korean Won (KRW) | Pharmacopuncture | Physical Therapy |
|---|---|---|
| Economic Evaluation Question-Productivity Loss | 600,000 ± 500,000 | 500,000 ± 400,000 |
Collected over 5 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pharmacopuncture | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Physical Therapy | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
This population includes all participants who were randomized and met the inclusion criteria, and were included in the baseline analysis for each arm.
| Age, Categorical(Participants) | Pharmacopuncture | Physical Therapy | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 15 | 30 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Pharmacopuncture | Physical Therapy | Total |
|---|---|---|---|
| Mean | 44 (19 to 64) | 44 (19 to 64) | 44 (19 to 64) |
| Sex: Female, Male(Participants) | Pharmacopuncture | Physical Therapy | Total |
|---|---|---|---|
| Female | 15 | 15 | 30 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Pharmacopuncture | Physical Therapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 15 | 15 | 30 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Pharmacopuncture | Physical Therapy | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 15 | 15 | 30 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Pharmacopuncture | Physical Therapy | Total |
|---|---|---|---|
| South Korea | 15 | 15 | 30 |
| Knee pain numeric rating scale, NRS(scores on a scale) | Pharmacopuncture | Physical Therapy | Total |
|---|---|---|---|
| Mean | 5.62 ± 0.29 | 6.12 ± 0.29 | 5.87 ± 0.29 |
| Knee pain visual analogue scale, VAS(scores on a scale) | Pharmacopuncture | Physical Therapy | Total |
|---|---|---|---|
| Mean | 56.77 ± 3.56 | 61.59 ± 3.56 | 59.18 ± 3.56 |
5 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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Jaseng Medical Foundation