Shoe stiffening inserts for pain of the big toe joint of the foot

Not Applicable

Completed

• Conditions: Osteoarthritis of the first metatarsophalangeal joint; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12616000552482
• Lead Sponsor: a Trobe University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

(i) Aged at least 18 years, (ii) report having pain in the first metatarsophalangeal joint (MTPJ) on most days for at least 12 weeks, (iii) report having pain rated at least 30 mm on a 100 mm visual analogue scale (VAS), (iv) have pain upon palpation of the dorsal aspect of the first MTPJ and restricted first MTPJ dorsiflexion (less than 64 degrees of dorsiflexion range of motion), (v) be able to walk household distances (>50 meters) without the aid of a walker, crutches or cane, (vi) be willing to have their foot x-rayed, (vii) be willing to attempt to not receive additional interventions (such as shoe modifications, physiotherapy, foot orthoses, intra-articular injections, or surgery) for the first MTPJ pain during the course of the study, (viii) be able to reach feet to perform ‘rehabilitation therapy’ of the first MTPJ, and (ix) be willing to attempt to discontinue consuming any pain relieving medications for first MTPJ OA (except paracetamol [up to 4 grams per day] which will be rescue medication) for at least 14 days prior to the baseline assessment and during the study period. Participants who consume 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, 12, 26 and 52 weeks.

Exclusion Criteria

(i) Previous first MTPJ surgery, (ii) currently pregnant, (iii) significant first metatarsophalangeal joint (MTPJ) deformity including hallux valgus (defined as a score of 2 or 3 using the Manchester scale, (iv) presence of one or more conditions within the foot or ankle that could confound pain and functional assessments of the first MTPJ such as forefoot pain that is not first MTPJ osteoarthritis, (v) presence of any systemic inflammatory condition such as gout or rheumatoid arthritis, (vi) any medical condition that, in the opinion of the investigators, makes the participant unsuitable for inclusion (e.g., clinically important pain in the musculoskeletal system other than the first MTPJ), (vii) an inability to speak and read English, (viii) cognitive impairment (ix) intra-articular injections (such as corticosteroids) at the first MTPJ in the previous 3 months, (x) unwilling to discontinue use of any foot orthotic devices (if currently wearing them) (xi) currently wearing shoe stiffening inserts, (xii) most regularly worn shoes not be able to accommodate the shoe stiffening inserts.

Study & Design

• Study Type: Interventional
• Study Design: Not specified