MedDataX Logo

The Clinical Effectiveness of Static Resting Splints in Early Rheumatoid Arthritis

NCT ID: NCT00474877

Last Updated: 2007-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2004-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Static resting splints

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Southampton

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jo E Adams, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southampton

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Southampton

Southampton, Hants, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MREC/01/6/43

Identifier Type: -

Identifier Source: org_study_id