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The Clinical Effectiveness of Static Resting Splints in Early Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
University of Southampton
ClinicalTrials.gov Identifier:
NCT00474877
First received: May 16, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

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 Intervention
Rheumatoid Arthritis
Device: Static resting splints

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Health Services Research
Official Title: The Clinical Effectiveness of Static Resting Splints in Early Rheumatoid Arthritis: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Southampton:

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

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

Enrollment: 120
Study Start Date: October 2001
Study Completion Date: April 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00474877     History of Changes
Other Study ID Numbers: MREC/01/6/43
Study First Received: May 16, 2007
Last Updated: May 16, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Southampton:
Clinical
Splints
Rheumatoid

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

ClinicalTrials.gov processed this record on November 20, 2014