中文版下背痛標準結果測量之一致性及先期隨機臨床試驗

Chinese Version of the Standardized Outcome Measures for Low Back Pain and a Pilot Study

李連輝(Liang-Huei Lee) ； 呂怡靜(Yi-Jing Lue) ； 嚴明芳(Amy Ming-Fang Yen) ； 陳秀熙(Tony Hsiu-Hsi Chen) ； 謝麗貞(Lisa Li-Chen Hsieh)

《物理治療》 31卷4期 (2006/08) Pp. 237-245

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.

關鍵字

中文版標準結果測量 ； 下背痛 ； 先期隨機臨床試驗

並列摘要

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.

並列關鍵字

Chinese version of standardized outcome measures ； Low back pain ； Pilot clinical trial