ACTRN12620000276954
Terminated
未知
Rocker sole footwear for the treatment of painful midfoot osteoarthritis: a pilot randomised controlled trial
niversity of South Australia0 sites4 target enrollmentMarch 3, 2020
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- niversity of South Australia
- Enrollment
- 4
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
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