Footwear for Osteoarthritis of the Lateral Knee: the FOLK Trial.

Not Applicable

• Conditions: Knee Osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12618001864213
• Lead Sponsor: The University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-15
• Study Completion: 2020-06-10
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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).

Exclusion Criteria

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified