Pharmacopuncture Therapy for Chronic Knee Pain

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

Study Overview

• Status: Completed
• Conditions: Chronic Knee Pain
• Intervention / Treatment: Procedure: Pharmacopuncture; Procedure: Physical therapy

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Daejeon, South Korea, 35262
    • Daejeon Jaseng Hospital of Korean Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacopuncture; 20 patients with pharmacoacupuncture	Procedure: Pharmacopuncture; 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.
Active Comparator: Physical therapy; 20 patients with physical therapy	Procedure: Physical 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Screening day(W-1)
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.	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.	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.	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.	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.	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.	Week 4
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.	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.	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.	Week 4

Collaborators and Investigators

• Sponsor: Jaseng Medical Foundation
• Investigators: Principal Investigator: Sunah Kim, KMD, Daejeon Jaseng Hospital of Korean Medicine

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2022
• Primary Completion (Actual): July 12, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pharmacopuncture; Chronic knee Pain
• Additional Relevant MeSH Terms: Therapeutics; Rehabilitation; Physical Therapy Modalities
• Other Study ID Numbers: JS-CT-2022-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No