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物理疗法对髋关节炎患者疼痛和功能的影响:一项随机临床试验。

Effect of physical therapy on pain and function in patients with hip osteoarthritis: a randomized clinical trial.

机构信息

Centre for Health, Exercise and Sports Medicine, School of Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.

Centre for Musculoskeletal Outcomes Research, Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.

出版信息

JAMA. 2014 May 21;311(19):1987-97. doi: 10.1001/jama.2014.4591.


DOI:10.1001/jama.2014.4591
PMID:24846036
Abstract

IMPORTANCE: There is limited evidence supporting use of physical therapy for hip osteoarthritis. OBJECTIVE: To determine efficacy of physical therapy on pain and physical function in patients with hip osteoarthritis. DESIGN, SETTING, AND PARTICIPANTS: Randomized, placebo-controlled, participant- and assessor-blinded trial involving 102 community volunteers with hip pain levels of 40 or higher on a visual analog scale of 100 mm (range, 0-100 mm; 100 indicates worst pain possible) and hip osteoarthritis confirmed by radiograph. Forty-nine patients in the active group and 53 in the sham group underwent 12 weeks of intervention and 24 weeks of follow-up (May 2010-February 2013) INTERVENTIONS: Participants attended 10 treatment sessions over 12 weeks. Active treatment included education and advice, manual therapy, home exercise, and gait aid if appropriate. Sham treatment included inactive ultrasound and inert gel. For 24 weeks after treatment, the active group continued unsupervised home exercise while the sham group self-applied gel 3 times weekly. MAIN OUTCOMES AND MEASURES: Primary outcomes were average pain (0 mm, no pain; 100 mm, worst pain possible) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0 no difficulty to 68 extreme difficulty) at week 13. Secondary outcomes were these measures at week 36 and impairments, physical performance, global change, psychological status, and quality of life at weeks 13 and 36. RESULTS: Ninety-six patients (94%) completed week 13 measurements and 83 (81%) completed week 36 measurements. The between-group differences for improvements in pain were not significant. For the active group, the baseline mean (SD) visual analog scale score was 58.8 mm (13.3) and the week-13 score was 40.1 mm (24.6); for the sham group, the baseline score was 58.0 mm (11.6) and the week-13 score was 35.2 mm (21.4). The mean difference was 6.9 mm favoring sham treatment (95% CI, -3.9 to 17.7). The function scores were not significantly different between groups. The baseline mean (SD) physical function score for the active group was 32.3 (9.2) and the week-13 score was 27.5 (12.9) units, whereas the baseline score for the sham treatment group was 32.4 (8.4) units and the week-13 score was 26.4 (11.3) units, for a mean difference of 1.4 units favoring sham (95% CI, -3.8 to 6.5) at week 13. There were no between-group differences in secondary outcomes (except greater week-13 improvement in the balance step test in the active group). Nineteen of 46 patients (41%) in the active group reported 26 mild adverse effects and 7 of 49 (14%) in the sham group reported 9 mild adverse events (P = .003). CONCLUSIONS AND RELEVANCE: Among adults with painful hip osteoarthritis, physical therapy did not result in greater improvement in pain or function compared with sham treatment, raising questions about its value for these patients. TRIAL REGISTRATION: anzctr.org.au Identifier: ACTRN12610000439044.

摘要

重要性:目前仅有有限的证据支持物理治疗对髋关节炎的疗效。 目的:确定物理治疗对髋关节炎患者疼痛和身体功能的疗效。 设计、设置和参与者:一项随机、安慰剂对照、参与者和评估者双盲试验,涉及 102 名社区志愿者,他们的髋关节疼痛水平为视觉模拟评分(VAS)的 40 或更高(范围为 0-100mm;100 表示最严重的疼痛),并且通过 X 线证实患有髋关节炎。49 名活跃组患者和 53 名假手术组患者接受了 12 周的干预和 24 周的随访(2010 年 5 月至 2013 年 2 月)。 干预措施:参与者在 12 周内接受了 10 次治疗。积极治疗包括教育和建议、手法治疗、家庭运动,如果需要还包括助行器。假手术治疗包括非活性超声和惰性凝胶。治疗结束后 24 周,活跃组继续进行无人监督的家庭运动,而假手术组每周自我应用凝胶 3 次。 主要结果和措施:主要结局是第 13 周时的平均疼痛(0mm,无痛;100mm,最严重的疼痛)和身体功能(西部安大略省和麦克马斯特大学骨关节炎指数,0 无困难到 68 极度困难)。次要结局是第 36 周时的这些指标以及第 13 周和第 36 周时的损伤、身体表现、整体变化、心理状态和生活质量。 结果:96 名患者(94%)完成了第 13 周的测量,83 名患者(81%)完成了第 36 周的测量。两组间疼痛改善的差异不显著。对于活跃组,基线平均(SD)VAS 评分为 58.8mm(13.3),第 13 周评分为 40.1mm(24.6);对于假手术组,基线评分为 58.0mm(11.6),第 13 周评分为 35.2mm(21.4)。平均差值为 6.9mm,假手术组有优势(95%CI,-3.9 至 17.7)。两组间的功能评分没有显著差异。活跃组的基线平均(SD)身体功能评分为 32.3(9.2),第 13 周评分为 27.5(12.9)单位,而假手术组的基线评分为 32.4(8.4)单位,第 13 周评分为 26.4(11.3)单位,活跃组有 1.4 个单位的优势(95%CI,-3.8 至 6.5)。次要结局(除活跃组的平衡踏步测试在第 13 周有更大的改善外)两组间无差异。46 名活跃组患者中有 19 名(41%)报告了 26 例轻度不良反应,49 名假手术组患者中有 7 名(14%)报告了 9 例轻度不良反应(P=0.003)。 结论和相关性:在患有髋部疼痛性骨关节炎的成年人中,与假手术相比,物理治疗并未导致疼痛或功能的改善更大,这对这些患者的治疗价值提出了质疑。 试验注册:anzctr.org.au Identifier: ACTRN12610000439044.

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