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The Clinical Effectiveness of Static Resting Splints in Early Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00474877
Recruitment Status : Completed
First Posted : May 17, 2007
Last Update Posted : May 17, 2007
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Device: Static resting splints Not Applicable

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  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Health Services Research
Official Title: The Clinical Effectiveness of Static Resting Splints in Early Rheumatoid Arthritis: a Randomized Controlled Trial
Study Start Date : October 2001
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Dominant power hand grip (Newtons) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. MCPJ ulnar deviation [ Time Frame: 12 months ]
  2. Michigan Hand Outcome Questionnaire [ Time Frame: 12 months ]
  3. Applied dexterity - Button Board Arthritis Hand Function Test [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474877


Locations
United Kingdom
University of Southampton
Southampton, Hants, United Kingdom, SO17 1BJ
Sponsors and Collaborators
University of Southampton
Investigators
Principal Investigator: Jo E Adams, PhD University of Southampton

ClinicalTrials.gov Identifier: NCT00474877     History of Changes
Other Study ID Numbers: MREC/01/6/43
First Posted: May 17, 2007    Key Record Dates
Last Update Posted: May 17, 2007
Last Verified: May 2007

Keywords provided by University of Southampton:
Clinical
Splints
Rheumatoid

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases