None listed
Conditions
Brief summary
Project aim: The aim of this project is to determine the effectiveness and tolerability of full-length shoe-stiffening inserts for the treatment of osteoarthritis of the big-toe joint of the foot. Rationale: Osteoarthritis of the big-toe joint is common and painful. Although full-length shoe-stiffening inserts are a recommended treatment for this condition, the evidence supporting their use is lacking.
Interventions
Participants will be given a single (or pair depending if symptoms are bilateral) full-length shoe stiffening insert. The shoe insert will be fabricated from ~1 mm semi-rigid carbon graphite (Otto Bock Springlite Carbon Foot Plates [Registered Trademark]) and will have the following design characteristics: (i) full length, in that the insert extends from the heel to the tip of the toes, (ii) no arch build-up or contour at the heel.
Participants will be advised to wear the shoe insert(s) in the
Participants will be given a single (or pair depending if symptoms are bilateral) full-length shoe stiffening insert. The shoe insert will be fabricated from ~1 mm semi-rigid carbon graphite (Otto Bock Springlite Carbon Foot Plates [Registered Trademark]) and will have the following design characteristics: (i) full length, in that the insert extends from the heel to the tip of the toes, (ii) no arch build-up or contour at the heel. Participants will be advised to wear the shoe insert(s) in the shoe(s) they most frequently wear, and this will differ on a case by case basis. The intervention will be used for the entire duration of the trial (3 months).
Sponsors
Shannon Munteanu
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(i) aged at least 18 years; (ii) report first metatarsophalangeal (MTPJ) pain for at least 3 months; (iii) report current pain severity of at least 20 mm on a 100 mm visual analogue pain scale at the first MTPJ; (iv) have radiographic evidence of first MTPJ osteoarthritis; (v) willing to discontinue taking all pain-relieving medications for the first MTPJ (except paracetamol) for two weeks prior to the baseline appointment then during the duration of the study; (vii) willing to attempt to refrain from using alternate treatment (such as physical therapy) for the pain at their first MTPJ during the study period; (viii) wear shoes that can accommodate the full-length shoe-stiffening inserts; (ix) able to ambulate without the need for assistive devices such as crutches or cane.
Exclusion criteria
(i) previous first MTPJ surgery; (ii) intra-articular injection at the first MTPJ in the previous 3 months; (iii) significant deformity of the first MTPJ including bunions; (iv) confounding conditions such as other musculoskeletal pathology of the lower limb(s); (v) inflammatory arthritis (including rheumatoid arthritis, gout, psoriatic arthritis); (vi) presence of diabetes or connective tissue disease (vii) currently wearing full-length shoe stiffening inserts or footwear that is unlikely to accommodate this intervention.
Outcome results
None listed