Chronic Knee PainNCT06505681
Pharmacopuncture Therapy for Chronic Knee Pain
A study testing Pharmacopuncture and Physical therapy in people with Chronic Knee Pain, run by Jaseng Medical Foundation at 1 site in South Korea.
Trial summary
This study is a pragmatic randomized controlled trial. Condition/disease: Chronic Knee Pain. Intervention: Pharmacopuncture Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Chronic Knee Pain
- What is being tested?
- Pharmacopuncture and Physical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Dec 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, 35262
About this study
Official title: Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Chronic Knee Pain: A Pilot Study
This study is a pragmatic randomized controlled trial. Condition/disease: Chronic Knee Pain. Intervention: Pharmacopuncture
Read the 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.
- Conditions
- Chronic Knee Pain
- Being tested
- Pharmacopuncture, Physical therapy
- Keywords
- Chronic knee Pain, Pharmacopuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PharmacopunctureProcedure or surgery
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.
Physical therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacopuncture | Experimental | 20 patients with pharmacoacupuncture Receives: Procedure: Pharmacopuncture |
| Physical therapy | Active comparator | 20 patients with physical therapy Receives: Procedure: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 4
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start28 Dec 2022
- Primary completion12 Jul 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Knee PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunah Kim, KMD, Principal investigator, Daejeon Jaseng Hospital of Korean Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505681
- Sponsor's protocol ID
- JS-CT-2022-16
- Status last verified
- May 2026
- First submitted
- 11 Jul 2024
- Last updated
- 2 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jeong MI, Lim JK, Kim YJ, Jeon YS, Kim S, Kim CY, Park YC, Kim EJ, Hong Y, Nam D, Lee YJ, Kim D, Ha IH. Effectiveness and Safety of Pharmacopuncture Therapy Compared to Standard Physical Therapy in Patients with Chronic Knee Pain: A Pilot Study for a Pragmatic Randomized Controlled Trial. Medicina (Kaunas). 2025 Jun 18;61(6):1106. doi: 10.3390/medicina61061106.
PubMed 40572793
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Chronic Knee Pain: A Pilot Study
- ClinicalTrials.gov ID
- NCT06505681
- Acronym / sponsor ID
- JS-CT-2022-16
- Conditions
- Chronic Knee Pain
- Keywords
- Chronic knee Pain, Pharmacopuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Posted 2 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacopuncture | Experimental | Procedure: Pharmacopuncture20 patients with pharmacoacupuncture |
| Physical therapy | Active comparator | Procedure: Physical therapy20 patients with physical therapy |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PharmacopunctureThe 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. | Procedure or surgery | Pharmacopuncture |
| Physical therapyThe 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. | Procedure or surgery | Physical therapy |
Primary outcome
Knee Pain Numeric Rating Scale, NRS
Time frame: 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).
10 secondary outcomes
Knee Pain Visual Analogue Scale, VAS
Time frame: Week 4
Range of Motion, ROM
Time frame: Week 4
Korean Western Ontario & McMaster, K-WOMAC
Time frame: Week 4
Short Form-12 Health Survey Version 2, SF-12 v2
Time frame: Week 4
EuroQol-5 Dimension, EQ-5D-5L
Time frame: Week 4
Patient Global Impression of Change, PGIC
Time frame: Week 4
Credibility and Expectancy
Time frame: Screening day(W-1)
Economic Evaluation Question-Medical Costs
Time frame: Week 4
Economic Evaluation Question-Time Cost
Time frame: Week 2
Economic Evaluation Question-Productivity Loss
Time frame: Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40572793Jeong MI, Lim JK, Kim YJ, Jeon YS, Kim S, Kim CY, Park YC, Kim EJ, Hong Y, Nam D, Lee YJ, Kim D, Ha IH. Effectiveness and Safety of Pharmacopuncture Therapy Compared to Standard Physical Therapy in Patients with Chronic Knee Pain: A Pilot Study for a Pragmatic Randomized Controlled Trial. Medicina (Kaunas). 2025 Jun 18;61(6):1106. doi: 10.3390/medicina61061106.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunah Kim, KMD principal investigator
Daejeon Jaseng Hospital of Korean Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacopuncture and Physical therapy in people with Chronic Knee Pain, run by Jaseng Medical Foundation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Pain Numeric Rating Scale, NRS (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06505681, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.