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患者教育联合或不联合手法治疗与对照组在髋关节骨关节炎患者中的比较。一项三臂平行组随机临床试验的原理验证。

Patient education with or without manual therapy compared to a control group in patients with osteoarthritis of the hip. A proof-of-principle three-arm parallel group randomized clinical trial.

机构信息

Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Nordic Institute of Chiropractic and Clinical Biomechanics, Odense, Denmark.

出版信息

Osteoarthritis Cartilage. 2013 Oct;21(10):1494-503. doi: 10.1016/j.joca.2013.06.009. Epub 2013 Jun 21.

DOI:10.1016/j.joca.2013.06.009
PMID:23792189
Abstract

OBJECTIVE

To investigate the effectiveness of a patient education (PE) program with or without the added effect of manual therapy (MT) compared to a minimal control intervention (MCI).

METHODS

In a single-center university hospital setting, a total of 118 patients with clinical and radiographic unilateral hip osteoarthritis (OA) from primary care were randomized into one of three groups: PE, PE plus MT or MCI. The PE was taught by a physiotherapist involving five sessions. The MT was delivered by a chiropractor involving 12 sessions and the MCI included a home stretching program. Primary outcome was self-reported pain severity on an 11-box numeric rating scale (NRS) immediately following a 6-week intervention period. Patients were followed for 1 year.

RESULTS

Primary analysis included 111 patients (94%). In the combined group (PE + MT), a clinically relevant reduction in pain severity compared to the MCI of 1.90 points (95% confidence interval (CI) 0.9-2.9) was achieved. Effect size (Cohen's d) for the PE + MT minus the MCI was 0.92 (95% CI 0.41-1.42). Number needed to treat for PE + MT was 3 (95% CI 2-7). No difference was found between the PE and MCI groups, with mean difference 0.0 (95% CI -1.0 to 1.0). At 12 months, not including patients receiving hip surgery the statistically significant difference favoring PE + MT was maintained.

CONCLUSIONS

For primary care patients with OA of the hip, a combined intervention of MT and PE was more effective than a MCI. PE alone was not superior to the MCI.

TRIAL REGISTRATION

clinicaltrials.govNCT01039337.

摘要

目的

比较患者教育(PE)计划加或不加手动治疗(MT)与最小对照干预(MCI)的效果。

方法

在单中心大学医院环境中,共纳入来自初级保健的 118 名单侧髋关节骨关节炎(OA)的临床和影像学患者,随机分为三组:PE 组、PE 加 MT 组或 MCI 组。PE 由物理治疗师教授,共 5 次;MT 由脊椎指压治疗师实施,共 12 次;MCI 包括家庭伸展计划。主要结局为 6 周干预后即刻的自我报告的数字评分量表(NRS)疼痛严重程度。患者随访 1 年。

结果

主要分析包括 111 名患者(94%)。在联合组(PE+MT)中,与 MCI 相比,疼痛严重程度有临床意义的降低了 1.90 分(95%置信区间(CI)为 0.9-2.9)。PE+MT 减去 MCI 的效应大小(Cohen's d)为 0.92(95%CI 为 0.41-1.42)。PE+MT 的治疗需要数为 3(95%CI 为 2-7)。PE 组与 MCI 组之间无差异,平均差异为 0.0(95%CI -1.0 至 1.0)。在 12 个月时,不包括接受髋关节手术的患者,仍保持了有利于 PE+MT 的统计学显著差异。

结论

对于初级保健髋关节 OA 患者,MT 和 PE 的联合干预比 MCI 更有效。PE 单独治疗并不优于 MCI。

试验注册

clinicaltrials.govNCT01039337。

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