A case-series study to explore the efficacy and tolerability of full-length shoe stiffening inserts in treating first metatarsophalangeal joint osteoarthritis

Phase 2

Completed

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

• Registration Number: ACTRN12613000051741
• Lead Sponsor: Shannon Munteanu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Foot Health Status Questionnaire (Foot pain subscale)[One month and three months (primary outcome)]

Secondary Outcome Measures

Name	Time	Method
Foot Health Status Questionnaire (foot function subscale)[One and three months];Self-reported magnitude of symptom change (15-point Likert scale)[One and three months];Physical activity (in previous week) (7-day recall questionnaire: Sallis et al., 1985)[One and three months];Use of co-interventions (self-report at one and three month assessments and via a diary)[One and three months];Comfort of shoe inserts (5-point Likert scale)[Baseline, one and three months];Adverse events (self-report at one and three month assessments). Adverse events expected typically include the development of musculoskeletal pain within the lower limb such as Achilles tendon pain, or dermatological lesions such as hyperkeratosis or blistering of the feet.[One and three months];Compliance with shoe inserts (self-report)[One and three months];Dynamic plantar pressures (during walking) with and without shoe inserts[Baseline and three months]