Pharmacopuncture Therapy for Chronic Knee Pain
NCT Number: NCT06505681
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Knee Pain
Interventions: PROCEDURE: Pharmacopuncture|PROCEDURE: Physical therapy
Sponsor: Jaseng Medical Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-12-28
Completion Date: 2023-11-30
Locations: Daejeon Jaseng Hospital of Korean Medicine, Daejeon, 35262, Korea, Republic of

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

Primary Outcome Measures: 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 Outcome Measures: Knee pain visual analogue scale, VAS, It is an evaluation index that records the degree of pain felt by the patient along a 100 mm horizontal line with one end indicating no pain and the other end indicating the most severe pain imaginable. This is one way to determine the patient's pain level, and the patient enters the degree of knee pain over the past week as a point on a line., Week 1, 2, 3, 4, 6|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 flexion, and right flexion. If measurement is not possible due to pain, it will be recorded as UC., Screening day(W-1), Week 1, 2, 3, 4, 6|Korean Western Ontario & McMaster, K-WOMAC, K-WOMAC is a 24-item questionnaire developed to evaluate the degree of disability related to knee pain. Each question is divided into 5 levels and consists of 5 questions in the pain evaluation section, 2 questions in the stiffness evaluation section, and 17 questions in the functional disability evaluation section. The higher the score, the more severe the disability., Week 1, 4, 6|Short Form-12 Health Survey version 2, SF-12 v2, SF-12 v2 is a questionnaire that evaluates health-related quality of life (HRQoL) and consists of 12 questions in 8 areas (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health). It usually takes less than 5 minutes to complete, and higher scores indicate better health-related quality of life. SF-12 is used to evaluate the functional health and well-being of patients and healthy people. Regarding the Korean version of the SF-12, Kim et al. verified the reliability and validity of its use to measure health-related quality of life in 1,000 Koreans., Week 1, 4, 6|EuroQol-5 Dimension, EQ-5D-5L, EQ-5D-5L is a method of evaluating health status from various aspects and then indirectly calculating the quality weight of a specific health status using pre-assigned preference scores for each functional level. It is the most widely used among several indirect measurement methods. there is. The EQ-5D-5L consists of 5 questions. Each question includes mobility, self-care, usual activities, pain/discomfort, and anxiety/depression ( Ask about the level of anxiety/depression, etc. Weights are assigned according to the level of each item, and the preference score calculation equation is presented based on these weights and constants., Week 1, 4, 6|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, 6|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)|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 1, 2, 3, 4, 6|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 1, 2, 3, 4, 6