南非一项针对等待关节置换术的骨关节炎患者的随机对照试验:由物理治疗师主导的为期六周的运动与教育干预后,疼痛有显著改善。

Significant improvements in pain after a six-week physiotherapist-led exercise and education intervention, in patients with osteoarthritis awaiting arthroplasty, in South Africa: a randomised controlled trial.

作者信息

Saw M M, Kruger-Jakins T, Edries N, Parker R

机构信息

Physiotherapy department, Tygerberg Hospital, Cape Town, South Africa.

ICAS South Africa, Musculoskeletal Health, Johannesburg, South Africa.

出版信息

BMC Musculoskelet Disord. 2016 May 27;17:236. doi: 10.1186/s12891-016-1088-6.

Abstract

BACKGROUND

A major challenge facing those with late stage osteoarthritis is delayed surgery due to waiting lists. In South Africa patients wait years for a hip/knee arthroplasty. Affected patients require effective management to address their pain, especially while awaiting surgery. Existing literature is mostly available from high income countries exploring effects of interventions during short waiting periods. Research is warranted in low income countries where long waiting periods are common. This study explored the effects of a six-week physiotherapist-led exercise and education intervention on pain in this population.

METHODS

A randomised controlled trial was performed at two public hospitals in South Africa. Ethical approval and informed consent was obtained. 74 participants from arthroplasty waiting lists were randomly allocated to an intervention (n = 35) or control group (n = 39). The intervention included six physiotherapist-led group-based sessions (two hours/week of education, exercise and relaxation). The control group received usual care. Data collection was conducted by blinded physiotherapists at baseline, week six, 12 and month six. The primary outcome was pain, measured by the Brief Pain Inventory. Additionally, participants completed an open-ended questionnaire at month six, to gain insight regarding the intervention. Analysis was by intention to treat using two-way analysis of variance and post-hoc Tukey comparisons. Answers to subjective questions were analysed according to common themes that emerged.

RESULTS

The intervention group had significant improvements compared with the control group with moderate to large effect sizes (ES) on pain severity [week 6: p < 0.01, ES = 0.94, 95 % CI (0.45,1.41), month 6: p = 0.02. ES = 0.74, 95 % CI (0.26,1.2)] and moderate to large effects on pain interference [week 6: p < 0.01, ES = 1.2, 95 % CI (0.70,1.69), week 12: p = 0.04, ES = 0.68, 95 % CI (0.20,1.14), month 6: p < 0.01, ES = 0.98, 95 % CI (0.49,1.45)]. 53 % of participants reported that the intervention improved their pain.

CONCLUSIONS

The intervention resulted in sustained significant improvements in pain severity and interference in patients with hip/knee osteoarthritis, awaiting arthroplasty compared with a control group. Additionally, participants' individual feedback supported observed significant improvements in pain. Such an intervention appears to be effective in managing pain in this population and should be incorporated into practice for appropriate patients. Further research is being conducted to explore long term and postoperative outcomes.

CLINICAL TRIAL REGISTRATION

Pan African Clinical Trial Registry, PACTR201409000885765 , PACTR201507001186115 .

摘要

背景

晚期骨关节炎患者面临的一项重大挑战是由于等候名单导致手术延迟。在南非,患者等待髋关节/膝关节置换手术需要数年时间。受影响的患者需要有效的管理来缓解疼痛,尤其是在等待手术期间。现有文献大多来自高收入国家,探讨的是短期等候期间干预措施的效果。在低收入国家,等候时间较长的情况很常见,因此有必要开展相关研究。本研究探讨了由物理治疗师主导的为期六周的运动和教育干预对该人群疼痛的影响。

方法

在南非的两家公立医院进行了一项随机对照试验。获得了伦理批准并取得了知情同意。从关节置换等候名单中选取74名参与者,随机分为干预组(n = 35)或对照组(n = 39)。干预措施包括由物理治疗师主导的六次小组课程(每周两小时,包括教育、运动和放松)。对照组接受常规护理。数据由不知情的物理治疗师在基线、第六周、第十二周和第六个月进行收集。主要结局指标是疼痛,采用简明疼痛问卷进行测量。此外,参与者在第六个月完成了一份开放式问卷,以深入了解干预措施。采用意向性分析,运用双向方差分析和事后Tukey比较。根据出现的共同主题对主观问题的答案进行分析。

结果

与对照组相比,干预组在疼痛严重程度方面有显著改善,效应大小为中度至高度[第六周:p < 0.01,ES = 0.94,95% CI(0.45,1.41),第六个月:p = 0.02,ES = 0.74,95% CI(0.26,1.2)],在疼痛干扰方面有中度至高度效应[第六周:p < 0.01,ES = 1.2,95% CI(0.70,1.69),第十二周:p = 0.04,ES = 0.68,95% CI(0.20,1.14),第六个月:p < 0.01,ES = 0.98,95% CI(0.49,1.45)]。53%的参与者报告称干预措施改善了他们的疼痛。

结论

与对照组相比,该干预措施使等待关节置换的髋/膝骨关节炎患者的疼痛严重程度和干扰得到了持续显著改善。此外,参与者的个人反馈支持了观察到的疼痛显著改善情况。这种干预措施似乎对管理该人群的疼痛有效,应纳入适合患者的实践中。正在进行进一步研究以探索长期和术后结局。

临床试验注册

泛非临床试验注册中心,注册号PACTR201409000885765 ,PACTR201507001186115 。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1441/4884378/633565b86cae/12891_2016_1088_Fig1_HTML.jpg

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