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The Clinical Effectiveness of Static Resting Splints in Early Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:
The Clinical Effectiveness of Static Resting Splints in Early Rheumatoid Arthritis: a Randomized Controlled Trial

Clinical Trial Summary

This study tested the hypothesis that there would be a difference in the 12 month progression of structural hand impairment and hand function between a group of patients with early RA who received static resting splints and those that did not.

Clinical Trial Description

This study is a multi centred RCT recruiting patients across 8 rheumatology occupational therapy departments in the UK. Patients with early RA (<5 years) were recruited. The study followed patients over a 12 month treatment period. Patients were randomised to receive standardised occupational therapy or standardised occupational therapy plus static resting splints over 12 months. The primary outcome measure was dominant hand grip strength and secondary out measures included; dominant hand MCPJ ulnar deviation, the button board from the Arthritis Hand Function Test and the Michigan Hand Outcomes Questionnaire.

Data were analysed using ANCOVA. Baseline outcome values, Ritchie Scores at baseline and the number of intra articular wrist and hand steroid injections were controlled for as covariates.

This study is a multi centred RCT recruiting patients across 8 rheuamtology occupational therapy departments in the UK. Patients with early RA (<5 years) were recruited. The study followed patients over a 12 month treamtent period. Patients were randomised to receive standardised occupational therapy or standardised occupational therapy plus static resting splints over 12 months. The primary outcome measure was dominant hand grip strength and secondary out measures included; dominant hand MCPJ ulnar deviation, the button board from the Arthritis Hand Function Test and the Michigan Hand Outcomes Questionnaire.

Data were analysed using ANCOVA. Baseline outcome values, Ritchie Scores at baseline and the number of intra articular wirst and hand steroid injections were controlled for as covariates. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00474877
Study type Interventional
Source University of Southampton
Contact
Status Completed
Phase N/A
Start date October 2001
Completion date April 2004
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