None listed
Conditions
Brief summary
We are conducting a clinical trial to determine if cushioned shoe insoles are an effective treatment for big toe joint osteoarthritis. The participants will wear their allocated insoles at all times when wearing shoes for a 12 week period. The two different groups in this study are: 1. Cushioned insoles 2. Placebo insoles We will evaluate the effectiveness of the different insoles on pain and physical function at 12 weeks. Primary and secondary outcomes will be collected via online survey at baseline and 12 weeks. Our hypothesis is that flat cushioned shoe insoles will result in a greater improvement in pain and physical function for individuals suffering with first MTP OA.
Interventions
The intervention group will receive three pairs of cushioned insoles. The cushioned insoles will be flat 6mm blue EVA 120 (Shore A 20) shoe insoles. Insoles will be trimmed and fitted into participant’s footwear at the initial visit by the trial coordinator. This initial visit will last 90 minutes. At this time, participants will be advised to wear the insoles at all times when wearing shoes for 12 weeks, changing to a new pair of insoles every 4 weeks. Participants will complete a logbook to mo
The intervention group will receive three pairs of cushioned insoles. The cushioned insoles will be flat 6mm blue EVA 120 (Shore A 20) shoe insoles. Insoles will be trimmed and fitted into participant’s footwear at the initial visit by the trial coordinator. This initial visit will last 90 minutes. At this time, participants will be advised to wear the insoles at all times when wearing shoes for 12 weeks, changing to a new pair of insoles every 4 weeks. Participants will complete a logbook to monitor adherence, in the fourth, eighth and twelfth week of their study involvement.
The intervention group will receive three pairs of cushioned insoles. These insoles will be flat, 6 mm blue EVA 120 (Shore A 20) shoe insoles.
Participants attending the university biomechanics laboratory:
At the baseline visit, the trial coordinator will trim and fit the insoles to the participant’s footwear. This visit will last approximately 90 minutes.
Remote participants:
Participants who are unable to attend in person will be mailed all three pairs of insoles. They will receive written i
The intervention group will receive three pairs of cushioned insoles. These insoles will be flat, 6 mm blue EVA 120 (Shore A 20) shoe insoles. Participants attending the university biomechanics laboratory: At the baseline visit, the trial coordinator will trim and fit the insoles to the participant’s footwear. This visit will last approximately 90 minutes. Remote participants: Participants who are unable to attend in person will be mailed all three pairs of insoles. They will receive written instructions on how to trim the insoles to fit their footwear, if required. All participants will be instructed to wear the insoles at all times when wearing shoes for 12 weeks. They will be asked to change to a new pair of insoles every 4 weeks (i.e., at weeks 4 and 8). Adherence will be monitored using a logbook, which participants will complete at weeks 4, 8, and 12 of their study involvement.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed