Evaluating the effectiveness of Footwear on knee pain in people with Osteoarthritis of the Lateral Knee: the FOLK Trial.

The University of Melbourne0 个研究点目标入组 40 人开始时间: 2018年11月15日最近更新: 2024年4月15日

适应症

试验速览

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•i) aged 50 years or older;
•ii) report knee pain on most days of the past month;
•iii) report a minimum pain score of 4 on an 11-point numeric rating scale during walking over the previous week;
•iv) demonstrate Grade 2-4 tibiofemoral osteoarthritis on x-ray as determined by the Kellgren & Lawrence grading system; and
•v) demonstrate grade of lateral tibiofemoral joint space narrowing greater than medial tibiofemoral joint space narrowing according to a radiographic atlas (where Grade 0=no narrowing, 1=mild narrowing, 2=moderate narrowing, 3=severe narrowing).

•i) suffered knee pain for <3 months;
•ii) recent knee surgery (past 6 months) or planned surgery in next 6 months;
•iii) current use of shoe orthoses, customized shoes or ankle/knee braces;
•iv) current primary use of high heels, thongs or work boots that would restrict ability to wear study shoes 6 hours/day;
•v) had a hip or knee replacement on most painful knee;
•vi) had a high tibial osteotomy on most painful knee;
•vii) had any knee injections in the past 3 months or planned injections in next 6 months;
•viii) self-report any other muscular, joint or neurological condition affecting lower limb function;
•ix) self-report any systemic or inflammatory joint disease (e.g. rheumatoid arthritis);
•x) current or planned use of a gait aid in the next 6 months
•xi) inability to understand written/spoken English
•xii) unable to commit to study requirements (e.g. wearing shoes, attending appointments, completing outcomes, do not have foot size in the range of 6 to 12US for women and 7 to 13US for men).

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