The Clinical Effectiveness of Static Resting Splints in Early Rheumatoid Arthritis
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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 |
- Dominant power hand grip (Newtons) [ Time Frame: 12 months ]
- 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 |
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 |
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| United Kingdom | |
| University of Southampton | |
| Southampton, Hants, United Kingdom, SO17 1BJ | |
| 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 Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013