Conservative management of first carpometacarpal (CMC) joint osteoarthritis: a single blinded randomised controlled trial

Not Applicable

Recruiting

• Conditions: Osteoarthritis of the first Carpometacarpal joint (of the thumb); Musculoskeletal - Osteoarthritis; Physical Medicine / Rehabilitation - Occupational therapy; Physical Medicine / Rehabilitation - Physiotherapy

• Registration Number: ACTRN12614000671662
• Lead Sponsor: Brisbane Hand and Upper Limb Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-25
• Last Update Posted: 1 February 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 276

Inclusion Criteria

1- 18 years and over
2- Clinical diagnosis of primary idiopathic 1st CMC joint osteoarthritis
3 - Minimal level of symptoms of either a pain score of at least 30 (out of 100) on VAS or 22 (out of 90) on the AUSCAN NRS 4.1 subscale

Exclusion Criteria

1- Inflammatory joint conditions including rheumatoid arthritis and gout
2- Significant untreated Dupuytren's Disease resulting in severely impaired function
3- History of previous conservative management of 1st CMC joint arthritis including use of a splint within the last 3 months
4- History of corticosteriod injection or Hyaluronate injection in either of the hands
5- Previous soft tissue injury or fracture of the thumb or wrist joints that has resulted in significant function limitation
6- Pregnancy
7- High medical dependency that may interfere with ability to return for assessments or compliance with interventions

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain measured using a 100 point (10 cm) visual analogue scale[Baseline (pre-intervention); 3 months; 6 months; 12 months; 24 months];Osteoarthritis Disease specific outcome Measure (AUSCAN Hand Osteoarthritis Index)[Baseline (pre-intervention); 3 months; 6 months; 12 months 24 months]

Secondary Outcome Measures

Name	Time	Method
Function using Patient Rated Wrist and Hand Evaluation[Baseline (pre-intervention); 3 months; 6 months; 12 months 24 months];Pinch Strength using a Pinch Gauge[Baseline (pre-intervention); 3 months; 6 months; 12 months 24 months];Global improvement measured using a Global Rating of Change Scale for symptoms and function[Baseline (pre-intervention); 3 months; 6 months; 12 months 24 months];Health rated quality of life measured using the EQ-5D[Baseline (pre-intervention); 3 months; 6 months; 12 months 24 months];Adverse events for the thumb orthosis which could include allergic dermatitis, skin maceration, pressure areas or heat rash.<br><br>Adverse events for the injection could include allergic reaction, abnormal systemic responses, dizziness, nausea, cognitive dysfunction.<br><br>[Baseline (pre-intervention); 3 months; 6 months; 12 months 24 months]