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临床试验/ACTRN12613000051741
ACTRN12613000051741已完成2 期

In people with first metatarsophalangeal joint osteoarthritis, are full-length shoe stiffening inserts an effective and safe treatment?

Shannon Munteanu0 个研究点目标入组 31 人开始时间: 2013年1月15日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
31

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • (i) aged at least 18 years; (ii) report first metatarsophalangeal (MTPJ) pain for at least 3 months; (iii) report current pain severity of at least 20 mm on a 100 mm visual analogue pain scale at the first MTPJ; (iv) have radiographic evidence of first MTPJ osteoarthritis; (v) willing to discontinue taking all pain-relieving medications for the first MTPJ (except paracetamol) for two weeks prior to the baseline appointment then during the duration of the study; (vii) willing to attempt to refrain from using alternate treatment (such as physical therapy) for the pain at their first MTPJ during the study period; (viii) wear shoes that can accommodate the full-length shoe-stiffening inserts; (ix) able to ambulate without the need for assistive devices such as crutches or cane.

排除标准

  • (i) previous first MTPJ surgery; (ii) intra-articular injection at the first MTPJ in the previous 3 months; (iii) significant deformity of the first MTPJ including bunions; (iv) confounding conditions such as other musculoskeletal pathology of the lower limb(s); (v) inflammatory arthritis (including rheumatoid arthritis, gout, psoriatic arthritis); (vi) presence of diabetes or connective tissue disease (vii) currently wearing full-length shoe stiffening inserts or footwear that is unlikely to accommodate this intervention.

研究者

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