University of Melbourne, Parkville, Victoria, Australia.
La Trobe University, Melbourne, Victoria, Australia.
Arthritis Care Res (Hoboken). 2021 Feb;73(2):250-258. doi: 10.1002/acr.24107.
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).
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.
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.
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.
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。
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。
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。
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。
