Clinical trial NCT06505681: Pharmacopuncture Therapy for Chronic Knee Pain
Official title: Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Chronic Knee Pain: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Knee Pain
Keywords: Chronic knee Pain
Pharmacopuncture
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Knee pain numeric rating scale, NRS
timeFrame: Screening day(W-1), Week 1, 2, 3, 4, 6
Secondary outcomes:
measure: Knee pain visual analogue scale, VAS
timeFrame: Week 1, 2, 3, 4, 6
measure: Range of motion, ROM
timeFrame: Screening day(W-1), Week 1, 2, 3, 4, 6
measure: Korean Western Ontario & McMaster, K-WOMAC
timeFrame: Week 1, 4, 6
measure: Short Form-12 Health Survey version 2, SF-12 v2
timeFrame: Week 1, 4, 6
measure: EuroQol-5 Dimension, EQ-5D-5L
timeFrame: Week 1, 4, 6
measure: Patient Global Impression of Change, PGIC
timeFrame: Week 4, 6
measure: Credibility and Expectancy
timeFrame: Screening day(W-1)
measure: Economic evaluation question-Medical costs
timeFrame: Week 1, 2, 3, 4, 6
measure: Economic evaluation question-Time cost
timeFrame: Week 2
measure: Economic evaluation question-Productivity loss
timeFrame: Week 1, 2, 3, 4, 6
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Daejeon Jaseng Hospital of Korean Medicine
Study officials:
affiliation: Daejeon Jaseng Hospital of Korean Medicine
name: Sunah Kim, KMD
role: PRINCIPAL_INVESTIGATOR
References: