Foot ORthoses for big Toe joint osteoarthritis: the FORT randomised controlled trial

Not Applicable

Completed

• Conditions: First metatarsophalangeal (big toe) joint osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12619000926134
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-03
• Study Completion: 2021-02-10
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

i)aged 45 years or older,
ii)report first MTP joint pain on most days of the month for at least 12 weeks,
iii)report a minimum pain score of 3 on an 11-point numerical rating scale during walking over the previous week,
iv)evidence of radiographic osteoarthritis (OA) (a score of 2 or more for osteophytes or joint space narrowing according to a radiographic atlas), due to a lack of accepted clinical diagnostic criteria for first MTP joint OA, 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 foot surgery or planned surgery on the affected side in the next 12 weeks;
ii)current use of foot orthoses or ankle braces,
iii)current primary use of high heels, thongs or other shoes that would restrict ability to wear orthoses,
iv)had any foot injections on the affected side in the past 6 months or planned injections in next 12 weeks,
v)self-report any other current muscular, joint or neurological condition affecting lower limb function,
vi)self-report any systemic or inflammatory joint disease (eg rheumatoid arthritis),
vii)grade 3 or 4 hallux valgus on the affected side,
viii)current or planned use of a gait aid in the next 12 weeks,
ix)inability to understand written/spoken English,
x)unable to commit to study requirements (eg wearing insoles, attending appointments, completing outcomes).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of first metatarsophalangeal (MTP) joint pain during walking. <br><br>Scored on an 11-point numerical rating scale (NRS) for average overall pain on walking in the last week. The scale ranges from 0 to 10; where 0=no pain and 10=worst pain possible.<br>[ Baseline and 12 weeks post commencement of treatment]