Pharmacopuncture Therapy for Chronic Knee Pain

NCT ID: NCT06505681

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-28
• Study Completion Date: 2023-11-30

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.

Conditions

Chronic Knee Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pharmacopuncture

20 patients with pharmacoacupuncture

Group Type: EXPERIMENTAL

Pharmacopuncture

Intervention Type: PROCEDURE

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 therapy

20 patients with physical therapy

Group Type: ACTIVE_COMPARATOR

Physical therapy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jaseng Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sunah Kim, KMD

Role: PRINCIPAL_INVESTIGATOR

Daejeon Jaseng Hospital of Korean Medicine

Locations

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 40572793 (View on PubMed)

Other Identifiers

JS-CT-2022-16

Identifier Type: -

Identifier Source: org_study_id