慢性膝痛に対する薬物穿刺療法

実験的：薬物穿刺

薬物鍼治療を受けた患者 20 名

手順：薬物穿刺

経穴の選択、挿入深度などは、患者の症状、画像検査結果、改善度などを考慮し、韓方医の臨床判断に基づいて決定されます。 薬物穿刺が施されたすべての経穴は、治療時に記録されます。

治療中に使用される薬物穿刺液の種類と投与量は、薬物穿刺を行う韓方医の臨床判断に基づいて決定されます。 使用された薬物穿刺溶液の種類と投与された総量（ml）を記録するために、遡及的なチャートレビューが行われます。

治療は週に 2 回、合計 3 週間実施され、正確な評価のためにすべてのセッションが記録されます。

アクティブコンパレータ：理学療法

理学療法を受けている患者 20 人

手順：理学療法

理学療法の選択、治療部位、治療期間は、患者様の症状、画像検査結果、改善度などを考慮し、医師の臨床判断に基づいて決定されます。 処方および実施された理学療法の種類、頻度、および領域が記録されます。

治療は週に 2 回、合計 3 週間実施され、正確な評価のためにすべてのセッションが記録されます。

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).

信頼性と期待感

参加者の治療に対する期待を評価するために、9 ポイントのリッカート スケールが使用されます。

最初の訪問で、参加者は「漢方鍼治療と理学療法があなたの症状をどの程度軽減すると思いますか?」と質問されました。 質問に対する回答としてスコアが選択されます (1 = まったく感じられない、5 = やや感じられる、9 = 非常に感じられる)。

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.