Pharmacopuncture Therapy for Chronic Knee Pain

NCT06505681 | Completed DMC

• 1 other identifier: JS-CT-2022-16
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a pragmatic randomized controlled trial. Condition/disease: Chronic Knee Pain. Intervention: Pharmacopuncture

Conditions

Chronic Knee Pain

Keywords

Chronic knee Pain; Pharmacopuncture

Outcome Measures

Primary Outcomes (1)

• 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).

  Screening day(W-1), Week 1, 2, 3, 4, 6

Secondary Outcomes (10)

• Knee pain visual analogue scale, VAS

  Week 1, 2, 3, 4, 6

• Range of motion, ROM

  Screening day(W-1), Week 1, 2, 3, 4, 6

• Korean Western Ontario & McMaster, K-WOMAC

  Week 1, 4, 6

• Short Form-12 Health Survey version 2, SF-12 v2

  Week 1, 4, 6

• EuroQol-5 Dimension, EQ-5D-5L

  Week 1, 4, 6

Study Arms (2)

Pharmacopuncture

EXPERIMENTAL

20 patients with pharmacoacupuncture

Procedure: Pharmacopuncture

Physical therapy

ACTIVE COMPARATOR

20 patients with physical therapy

Procedure: Physical therapy

Interventions

Pharmacopuncture 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.

Pharmacopuncture

Physical therapy 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.

Physical therapy

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, 35262, South Korea

Location

Related Publications (1)

• 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.

  PMID: 40572793 DERIVED

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Sunah Kim, KMD

  Daejeon Jaseng Hospital of Korean Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: December 28, 2022
• Primary Completion: July 12, 2023
• Study Completion: November 30, 2023
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)