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

The University of Melbourne0 sites40 target enrollmentNovember 15, 2018

Overview

No summary available.

Registry

who.int

Start Date

November 15, 2018

End Date

June 10, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•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