만성 무릎 통증에 대한 약물침 치료

실험적: 약침

약침치료 환자 20명

절차: 약침

경혈의 선택, 삽입 깊이 등은 환자의 증상, 영상 결과, 호전 정도 등을 고려하여 한의사의 임상적 판단에 따라 결정됩니다. 약침이 투여되는 모든 경혈은 치료 시점에 기록됩니다.

치료 시 사용되는 약침액의 종류와 용량은 전적으로 약침을 시행하는 한의사의 임상적 판단에 따라 결정됩니다. 사용된 약침 용액의 유형과 투여된 총량(ml)을 기록하기 위해 회고적 차트 검토가 수행됩니다.

치료는 주 2회, 총 3주간 진행되며, 정확한 평가를 위해 모든 치료 과정을 문서화할 예정입니다.

활성 비교기: 물리치료

물리치료 받는 환자 20명

절차: 물리치료

물리치료 방법의 선택, 치료부위, 치료기간은 환자의 증상, 영상검사 결과, 호전 정도 등을 고려하여 의사의 임상적 판단에 따라 결정됩니다. 처방 및 관리되는 물리 치료의 유형, 빈도 및 영역이 기록됩니다.

치료는 주 2회, 총 3주간 진행되며, 정확한 평가를 위해 모든 치료 과정을 문서화할 예정입니다.

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).

신뢰성과 기대

참가자의 치료 기대치를 평가하기 위해 9점 Likert 척도가 사용됩니다.

첫 방문 시 참가자들에게 “한침치료와 물리치료가 증상 완화에 어느 정도 도움이 된다고 생각하십니까?”라는 질문을 던졌다. 질문에 대한 답변으로 점수가 선택됩니다(1=전혀 그렇지 않음, 5=어느 정도, 9=매우 많음).

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.

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.

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.

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.

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.

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.

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.

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.

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.