Rocker sole footwear for the treatment of painful midfoot osteoarthritis: a pilot randomised controlled trial

Not Applicable

• Conditions: Osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12620000276954
• Lead Sponsor: niversity of South Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-03
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

(i) Aged equal or greater than 18 years
(ii) Midfoot pain (in at least one foot) for equal or greater than 3 months of average severity >2/10 on a 0-10 rating scale in the past week
(iii) Midfoot osteoarthritis on x-ray, defined as a score of >1 for osteophytes or joint space narrowing for the talonavicular, navicular-cuneiform, 1st or 2nd cuneiform-metatarsal joints. Scored using the LaTrobe Radiographic Foot OA Atlas (Menz et al 2007)
(iv) Willing and able to attend clinics on 2 occasions
(v) Willing and able to attend 2 times for MRI scans and once for footwear fitting
(vi) Willing to not receive additional interventions for their midfoot pain during the study
(vii) Willing to discontinue pain medications for their midfoot pain for 7 days prior to baseline assessments and for the duration of the study (except paracetamol up to 4g/day).
(viii) Able to commit to the study for 3 months
(ix) Able to walk household distances unaided

Exclusion Criteria

(i) Previous foot bone or joint surgery on the foot of interest, or corticosteroid injection to the midfoot in past 3 months
(ii) Currently wearing custom-made footwear or foot orthoses prescribed by a health care professional
(iii) Significant foot deformity precluding footwear fitting
(iv) History of inflammatory condition, fibromyalgia or peripheral neuropathy
(v) Other medical condition likely to impact on participant follow-up during study period (i.e. malignancy)
(vi) Other clinically significant joint pain (e.g. back, hip, knee) that is of greater intensity than midfoot pain at the time of the study, which may confound pain assessments
(vii) Currently pregnant
(viii) Body mass index (BMI) equal or greater than 40kg/m2
(ix) Cognitive impairment
(x) History of falls (2 or more in the past year)
(xi) Have contraindications to MRI

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participant recruitment (proportion of participants enrolled in the trial from total screened)[12 weeks ];Outcome measures completed (number of appointments attended [baseline and 12 week] and paper-based outcomes returned [4 weeks], reported as a proportion of total visits/time-points)<br><br>Recorded at baseline, 4 and 12 weeks[Recorded at baseline, 4 and 12 weeks [primary time-point]];Footwear use/compliance (number of hours participants wore their allocated footwear in the past week)<br><br>Recorded at 4 and 12 weeks[Recorded at baseline, 4 and 12 weeks [primary time-point]]