The Clinical Effectiveness of Static Resting Splints in Early Rheumatoid Arthritis

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00474877
• Lead Sponsor: University of Southampton

Brief 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.

Detailed 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 Timeline

• Study Start: 2001-10
• Study Completion: 2004-04
• Status Verified: 2007-05
• Study First Submitted: 2007-05-16
• Study First Submitted QC: 2007-05-16
• Last Update Submitted: 2007-05-16
• Study First Posted: 2007-05-17
• Last Update Posted: 2007-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Clinical diagnosis of RA, less than 5 years duration

Exclusion Criteria

• Patients with previous wrist and hand surgery, non-addressable fixed hand or wrist deformity, those from vulnerable group

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Dominant power hand grip (Newtons)	12 months

Secondary Outcome Measures

Name	Time	Method
Michigan Hand Outcome Questionnaire	12 months
Applied dexterity - Button Board Arthritis Hand Function Test	12 months
MCPJ ulnar deviation	12 months

Trial Locations

Locations (1)

University of Southampton; 🇬🇧 Southampton, Hants, United Kingdom