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物理治療

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篇名 文版下背痛標準結果測量之一致性及先期隨機臨床試驗
卷期 31:4
並列篇名 Chinese Version of the Standardized Outcome Measures for Low Back Pain and a Pilot Study
作者 李連輝呂怡靜嚴明芳陳秀熙謝麗貞
頁次 237-245
關鍵字 Pilot clinical trialLow back painChinese version of standardized outcome measures先期隨機臨床試驗下背痛中文版標準結果測量TSCI
出刊日期 200608

中文摘要

背景與目的:下背痛治療的研究常因各研究者所採用的測量工具不同,使得研究結果在國際間無法相互比較,因此使用中文化國際通用的標準結果測量問卷有其必要性,本研究目的是探討中文版標準結果測量問卷和原版問卷的一致性,並以先期隨機臨床試驗獲取臨床使用經驗。研究方法:以前向(forward)及反向(backward)的翻譯方法完成中文版標準結果測量問卷。檢驗一致性方面,由26位熟悉中、英文並曾患下背痛的病患填寫中文版及原版問卷以進行分析。獲取臨床使用經驗方面,以中文版問卷為測量工具,執行先期隨機(pilot randomized)臨床試驗。21位慢性下背痛病人接受隨機分配,11人在穴壓治療組,10人在對照組,接受為期一個月的治療介入,觀察臨床使用經驗,及比較問卷分辨治療結果的能力。結果:中文版標準結果測量問卷共包含四種問卷,所有問卷單項一致性分析中有76%的項目其Kappa值為1,其餘項目亦至少在0.89以上,表示中文版與原版具高度一致性。先期隨機臨床試驗問卷使用經驗顯示,除效能加權健康狀況的歐洲生活品質問卷(The EuroQoL Instrument for Utility-weighted Health Status Useful for Cost-effectiveness analysis)在評分時易造成困擾外,一般都可被受試者接受。治療結果中的核心結果測量(Core outcome measure)和修訂版歐氏失能問卷(Modified Version of the Oswestry Disability Questionnaire used in the AAOS lumbar cluster)可測量治療的差異(p<0.05),羅氏失能問卷(Roland and Morris Disability Questionnaire)所測量兩組治療的差異略遜(p<0.08)。而效能加權健康狀況的歐洲生活品質問卷,僅有一個項目可測量兩組的差異(p=0.05)。結論:中文版標準結果測量與原版問卷具一致性,在國內下背痛治療結果研究中具臨床使用價值。

英文摘要

Background and Purpose: The treatment outcomes for low back pain have been versatile in clinical trials and difficult in international comparison. A Chinese version of international standard outcome measuring tools for low back pain study is therefore required. A pilot clinical trial is conducted thereafter to obtain data collection experience and to observe the capability of these Chinese versions in differentiating low back pain among Chinese people. Methods: The standard outcome measures for low back pain were translated into Chinese versions by both forward and backward translation methods with verification on their correlation by data collected from 26 low back pain patients who were fluent in both Chinese and English. A pilot randomized clinical trial was conduced by using these Chinese versions as measuring tools. Among 21 recruited patients 11 were randomly assigned to acupressure group and 10 to the control group. Intervention of acupressure was set six sessions in one month. Results: Four questionnaires in the Chinese versions are all proved with good agreement by Kappa value. 76% of the items were identical whilst the rests were at least higher than 0.89. When collecting data in the study all questionnaires were well understood and accepted by patients except EuroQoL Instrument for utility-weighted health status which was found difficult to use. In differentiating low back pain among Chinese people, Core outcome measures and the modified Oswestry Disability questionnaire were found able to assess differences between groups, (p<0.05); whereas the Roland and Morris Disability questionnaire, (p<0.08). Only one item of EuroQoL Instrument for utility-weighted health status showed significant difference between groups (p=0.05). Conclusion: The Chinese versions of the standard outcome measures for low back pain have been demonstrated empirically to be valid as outcome measures for use in low back pain patients.

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