Clinical trial NCT00474877: 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
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Clinical
Splints
Rheumatoid
Lead sponsor: University of Southampton
Sponsor class: OTHER
First posted: 2007-05-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Dominant power hand grip (Newtons)
timeFrame: 12 months
Secondary outcomes:
measure: MCPJ ulnar deviation
timeFrame: 12 months
measure: Michigan Hand Outcome Questionnaire
timeFrame: 12 months
measure: Applied dexterity - Button Board Arthritis Hand Function Test
timeFrame: 12 months
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University of Southampton
state: Hants
Study officials:
affiliation: University of Southampton
name: Jo E Adams, PhD
role: PRINCIPAL_INVESTIGATOR
References: