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The Clinical Effectiveness of Static Resting Splints in Early Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Static resting splints
Sponsored by
University of Southampton
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Rheumatoid Arthritis focused on measuring Clinical, Splints, Rheumatoid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southampton

Outcomes

Primary Outcome Measures

Dominant power hand grip (Newtons)

Secondary Outcome Measures

MCPJ ulnar deviation
Michigan Hand Outcome Questionnaire
Applied dexterity - Button Board Arthritis Hand Function Test

Full Information

First Posted
May 16, 2007
Last Updated
May 16, 2007
Sponsor
University of Southampton
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1. Study Identification

Unique Protocol Identification Number
NCT00474877
Brief Title
The Clinical Effectiveness of Static Resting Splints in Early Rheumatoid Arthritis
Official Title
The Clinical Effectiveness of Static Resting Splints in Early Rheumatoid Arthritis: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Southampton

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Clinical, Splints, Rheumatoid

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Static resting splints
Primary Outcome Measure Information:
Title
Dominant power hand grip (Newtons)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
MCPJ ulnar deviation
Time Frame
12 months
Title
Michigan Hand Outcome Questionnaire
Time Frame
12 months
Title
Applied dexterity - Button Board Arthritis Hand Function Test
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo E Adams, PhD
Organizational Affiliation
University of Southampton
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southampton
City
Southampton
State/Province
Hants
ZIP/Postal Code
SO17 1BJ
Country
United Kingdom

12. IPD Sharing Statement

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The Clinical Effectiveness of Static Resting Splints in Early Rheumatoid Arthritis

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