The Clinical Effectiveness of Static Resting Splints in Early Rheumatoid Arthritis

May 16, 2007 updated by: University of Southampton

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Hants
      • Southampton, Hants, United Kingdom, SO17 1BJ
        • University of Southampton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dominant power hand grip (Newtons)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
MCPJ ulnar deviation
Time Frame: 12 months
12 months
Michigan Hand Outcome Questionnaire
Time Frame: 12 months
12 months
Applied dexterity - Button Board Arthritis Hand Function Test
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southampton

Investigators

  • Principal Investigator: Jo E Adams, PhD, University of Southampton

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

May 16, 2007

First Submitted That Met QC Criteria

May 16, 2007

First Posted (Estimate)

May 17, 2007

Study Record Updates

Last Update Posted (Estimate)

May 17, 2007

Last Update Submitted That Met QC Criteria

May 16, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MREC/01/6/43

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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