Insoles for big toe joint osteoarthritis: the SOLE randomised controlled trial

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 108

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of first MTP joint pain during walking.<br><br>Scored on an 11-point numerical rating scale (NRS) for average overall first MTP joint pain on walking in the last week. [ Baseline, 12 weeks post-intervention commencement (primary timepoint).]

Secondary Outcome Measures