Effect of insoles on severity of joint pain when walking for first metatarsophalangeal joint osteoarthritis: the SOLE randomised controlled trial

The University of Melbourne0 个研究点目标入组 108 人开始时间: 2023年12月14日最近更新: 2024年6月10日

适应症

试验速览

暂无简介。

•i)aged greater than or equal to 45 years,
•ii)report first MTP joint pain on most days of the month for the past 12 weeks,
•iii)report a minimum pain score of 4 on an 11-point numerical rating scale during walking over the previous week,
•iv)evidence of radiographic OA (a score of 2 or more for osteophytes or joint space narrowing according to a radiographic atlas), and
•v)report either no morning joint-related stiffness in the 1st MTP joint, or morning stiffness that lasts no longer than 30 minutes.

•i)previous first MTP joint surgery or planned foot surgery on the affected side in the next 12 weeks,
•ii)current use of foot orthoses, custom footwear or ankle braces,
•iii)current primary use of high heels, thongs or other shoes that preclude ability to wear insoles,
•iv)had any first MTP joint injections on the affected side in the past 6 months or planned foot injections in next 12 weeks,
•v)self-report any other current muscular, joint or neurological condition affecting lower limb function,
•vi)pain in another foot or ankle location that is greater than the pain in the study first MTP joint,
•vii)self-report any systemic or inflammatory joint disease (eg rheumatoid arthritis),
•viii)Moderate to severe hallux valgus based on a hallux abductus angle greater than 20 degs on xray,
•ix)current or planned use of a gait aid in the next 12 weeks,
•x)current or planned treatment for their first MTP joint OA in the next 12 weeks,
•xi)inability to understand written/spoken English,
•xii)unable to commit to study requirements (eg wearing insoles, attending appointments, completing outcomes),
•xiii)currently taking part in another OA study.

发起方