None listed
Conditions
Brief summary
Osteoarthritis affecting the first metatarsophalangeal joint of the foot is a common condition which results in pain, stiffness and impaired ambulation. Footwear modifications and foot orthoses are widely used in clinical practice to treat this condition, but their effectiveness has not been rigorously evaluated. The aim of this study is to compare the effectiveness of rocker-sole footwear and individualised prefabricated foot orthoses in reducing pain associated with first metatarsophalangeal joint osteoarthritis.
Interventions
Intervention: Pair of commercially-available rocker-sole shoes (MBT Matwa, Masai Barefoot Technology, Switzerland), characterized by a rounded sole in the anterior–posterior direction and a soft cushioned heel. Participants will be asked to wear the footwear as often as possible/practical during the 12 week trial period. Adherence will be documented at 4, 8 and 12 weeks. Participants will provide information concerning the number of hours per day and number of days they have worn their rocker-so
Intervention: Pair of commercially-available rocker-sole shoes (MBT Matwa, Masai Barefoot Technology, Switzerland), characterized by a rounded sole in the anterior–posterior direction and a soft cushioned heel. Participants will be asked to wear the footwear as often as possible/practical during the 12 week trial period. Adherence will be documented at 4, 8 and 12 weeks. Participants will provide information concerning the number of hours per day and number of days they have worn their rocker-sole shoes during the previous 4 weeks.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(i) be aged at least 18 years (ii) report having pain in the first MTPJ for at least 12 weeks (iii) report having pain rated at least 20mm on a 100mm visual analogue scale (iv) have less than 64 degrees of dorsiflexion range of motion of the first MTPJ (v) have pain upon palpation of the dorsal aspect of the first MTPJ (vi) be able to walk household distances (>50 meters) without the aid of a walker, crutches or cane (vi) be willing to attend the Health Sciences Clinic at La Trobe University (Melbourne, Victoria) for an initial assessment (vii) be willing to not receive additional interventions (such as physical therapy, foot orthoses, shoe modifications, intra-articular injections, or surgery) for the first MTPJ pain during the course of the study (viii) be willing to discontinue taking all pain-relieving medications to relieve pain at their first MTPJ (analgesics and non-steroidal anti-inflammatory medications [NSAIDs], except paracetamol up to 4g/day) for at least 14 days prior to the baseline assessment and during the study period. Participants who do take paracetamol for first MTPJ pain need to discontinue its use at least 24 hours prior to the baseline assessment and follow-up assessments at 4 and 12 weeks.
Exclusion criteria
(i) pregnancy (ii) previous surgery on the first MTPJ (iii) significant deformity of the first MTPJ including hallux valgus (grade of 3 or 4 scored using the Manchester Scale) (iv) presence of one or more conditions within the foot or ankle, in the opinion of the investigators, could confound pain and functional assessments of the first MTPJ, such as metatarsalgia, plantar fasciitis, pre-dislocation syndrome, Achilles tendinopathy, degenerative joint disease (other than the first MTPJ) (v) presence of any systemic inflammatory condition, such as inflammatory arthritis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, septic arthritis, acute pseudogout, gout or any other connective tissue disease (vi) any medical condition that, in the opinion of the investigators, makes the participant unsuitable for inclusion (e.g., severe progressive chronic disease, malignancy, clinically important pain in a part of the musculoskeletal system other than the first MTPJ, or fibromyalgia) (vii) cognitive impairment (defined as a score of <7 on the Short Portable Mental Status Questionnaire) (viii) intra-articular injections into the first MTPJ in the previous 6 months (ix) currently wearing contoured foot orthoses (although flat insoles will be permitted) (x) currently wearing specialised footwear (footwear that has been custom-made or ‘prescribed’ by a health-care practitioner) (xi) currently wearing shoes that would not be able to accommodate a foot orthosis (xii) older people with a history of recurrent falls (defined as 2 or more falls in the previous 12 months)
Outcome results
None listed