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足病医学干预与常规全科医生治疗第一跖趾关节症状性放射学骨关节炎的比较:一项随机临床可行性研究。

Podiatry Intervention Versus Usual General Practitioner Care for Symptomatic Radiographic Osteoarthritis of the First Metatarsophalangeal Joint: A Randomized Clinical Feasibility Study.

机构信息

University of Melbourne, Parkville, Victoria, Australia.

La Trobe University, Melbourne, Victoria, Australia.

出版信息

Arthritis Care Res (Hoboken). 2021 Feb;73(2):250-258. doi: 10.1002/acr.24107.

Abstract

OBJECTIVE

To determine the feasibility of a clinical trial comparing a podiatry intervention to usual general practitioner (GP) care for people with first metatarsophalangeal (MTP) joint osteoarthritis (OA).

METHODS

A 2-arm, participant- and assessor-blinded, randomized feasibility study was conducted over 12 weeks. Participants were age >40 years and had pain and radiographic OA in the first MTP joint. Participants in the podiatry group had 3 visits and received foot orthoses, exercise, manual therapy, and advice. Participants in the GP group had 1 visit and received medication advice/prescription and the same advice as the podiatry group. Primary outcomes were measures of feasibility (recruitment, attendance, and retention rates; percentage of prescribed exercise sessions completed; orthoses wear hours/day; treatment fidelity). Secondary outcomes included self-reported pain, function, satisfaction, adherence, adverse events, and dropouts.

RESULTS

A total of 236 people were screened, and 30 (13%) were included. All except 1 participant in the podiatry group attended the required clinical visits, and retention rates were 93% (podiatry group) and 80% (GP group). Participants completed 66% of the exercise sessions and wore orthoses for an average of 6.3 hours/day. Adherence to medication use was 5.3 on an 11-point numeric rating scale. Both treatment approaches improved pain and function by clinically important differences at 12 weeks.

CONCLUSION

A clinical trial comparing a podiatry intervention to usual GP care for people with first MTP joint OA is feasible. Given the improvements in pain and function observed, a larger appropriately powered clinical trial is warranted to evaluate the superiority of one treatment approach over the other.

摘要

目的

确定一项比较足病干预与普通全科医生(GP)常规护理治疗第一跖趾关节(MTP)骨关节炎(OA)患者的临床试验的可行性。

方法

一项为期 12 周的 2 臂、参与者和评估者双盲、随机可行性研究。参与者年龄>40 岁,第一 MTP 关节有疼痛和放射学 OA。足病组的参与者有 3 次就诊,接受足部矫形器、运动、手法治疗和建议。GP 组的参与者就诊 1 次,接受药物建议/处方和与足病组相同的建议。主要结局是可行性措施(招募、出席和保留率;完成规定运动课程的百分比;矫形器每天佩戴时间/小时;治疗一致性)。次要结局包括自我报告的疼痛、功能、满意度、依从性、不良事件和脱落。

结果

共有 236 人接受了筛查,其中 30 人(13%)入选。足病组除 1 人外,所有参与者均出席了所需的临床就诊,保留率分别为 93%(足病组)和 80%(GP 组)。参与者完成了 66%的运动课程,平均每天佩戴矫形器 6.3 小时。药物使用的依从性在 11 点数字评定量表上为 5.3。两种治疗方法均在 12 周时通过临床重要差异改善了疼痛和功能。

结论

一项比较足病干预与普通 GP 护理治疗第一 MTP 关节 OA 患者的临床试验是可行的。鉴于观察到的疼痛和功能改善,需要进行更大的、适当的、有能力的临床试验,以评估一种治疗方法相对于另一种方法的优越性。

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