None listed
Conditions
Brief summary
Osteoarthritis (OA) of the midfoot is a painful and disabling condition affecting 1 in 8 people aged over 50 years. Despite the high prevalence and burden of midfoot OA, there is very little evidence to guide the non-surgical management of this condition. Rocker sole shoes are a type of footwear designed to ‘offload’ the painful midfoot and despite anecdotal evidence to support their use in clinical practice, their efficacy has not been thoroughly investigated. Our multidisciplinary team will conduct a pilot randomised controlled trial (RCT) to gather information on feasibility and investigate the potential benefits of rocker sole footwear for painful midfoot OA, which is necessary to plan a rigorous RCT. Adults with painful midfoot OA (n=30) will be randomly allocated to receive either a pair of rocker sole footwear or standard footwear for 12 weeks. This study will assess key outcomes relating to trial feasibility (primary outcomes: recruitment, intervention use and adverse events) and if the footwear affects pain levels, foot-related disability and midfoot joint structure on MRI.
Interventions
Intervention : Pair of appropriately sized, commercially available rocker sole shoes (MBT GT Series, Massai International, Switzerland). Participants will be instructed to wear their allocated shoes as much as possible every day during the 3 month trial period, in place of their usual shoes. Adherence will be documented at 4 and 12 weeks by review of self-complete questionnaire.
Sponsors
University of South Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed