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

The University of Melbourne0 sites108 target enrollmentDecember 14, 2023

Overview

No summary available.

Registry

who.int

Start Date

December 14, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•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,