Condition category
Musculoskeletal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
26/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Margaret Sibley

ORCID ID

Contact details

St George's NHS Trust
Blackshaw Road
London
SW17 0QT
United Kingdom
+44 (0)20 8725 1848
margaret.sibley@stgeorges.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0236177886

Study information

Scientific title

Rheumatoid patients with wrist synovitis, if prescribed wrist splints do better in terms of grip strength, than if not prescribed

Acronym

Study hypothesis

To explore whether the prescribing of wrist splints for wrist swelling in patients with rheumatoid arthritis, improves grip strength (function), compared to patients not prescribed splints. Wrist splints are prescribed on a daily basis in rheumatology clinics and it is not known whether there is any significant benefit obtained from their use. Hopefully the outcome of the study will provide evidence based information on the effectiveness of wrist splints for treating wrist swelling.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Rheumatoid arthritis (RA)

Intervention

The purpose of this research project is to explore the effectiveness of wrist splints when prescribed for swelling of the wrist. A quantitative design will be used, as the outcome will rely on numerical data statistically analysed.

The plan is to recruit 40 patients from the rheumatology clinics who will have been examined by their physician and clinically diagnosed with swelling of the wrist.

All patients eligible to take part in the study will be asked to complete the Grip Ability Test (GAT). This is a reliable and validated outcome measure to determine grip strength. The groups receiving the standard splints and the dummy splints need to be as similar as possible and so there should be equal numbers of GAT positive and GAT negative in each group.

30 patients will be randomised to receive standard rheumatoid splints and 20 patients to receive elastic dummy wrist splints. The randomisation will be achieved as follows:
Stratified randomisation: Patients will be stratified according to the outcome of the GAT test into 2 groups (GAT positive and GAT negative). Those two groups will then be assigned to treatment or dummy according to a computer generated randomisation (We have sought a statisticians advice regarding the randomisation).

The study will be a two treatment, two period, cross over study carried out over 6 months (3 months with a standard splint then 3 months with a dummy splint and vice versa).

(If after 3 months there is a statistically significant benefit from the treatment arm, the study will of course be discontinued).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

To explore whether the prescribing of wrist splints for wrist swelling in patients with rheumatoid arthritis, improves grip strength (function), compared to patients not prescribed wrist splints.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

28/02/2006

Overall trial end date

14/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Stable DMARDs (disease modifying anti-rheumatic drugs) for the preceding month (to ensure patients are not experiencing any known side effects to the prescribed medication)
2. Male/Female 18 years of age or over (children not seen in department)
3. Confirmed diagnosis of rheumatoid arthritis
4. Disease duration >1 year (disease process confirmed)
5. Clinically diagnosed synovitis (swelling) of the wrist
6. Able to read, understand and complete consent form and questionnaire (as the patient will be seen in clinic and expected to complete them whilst in clinic)
7. Able to wear splints as directed (as the patient will need to fit and remove splints themselves)

Patients will be attending their routine follow up rheumatology clinic and seen by their clinician. Any patient presenting with a swollen wrist who has been prescribed a wrist splint by their clinician, will be invited to speak to the researcher and the purpose of the trial fully explained. All the rheumatology clinicians in the department will be made aware of the study and will be kept informed of its progress throughout, in order to aid identification of patients.

The patients will be given the appropriate written information and asked to read whilst in clinic. The researcher will be available at that time to discuss any queries.

If the patients fully meet the criteria and have agreed to enrol on the trial they will be seen by an assistant and randomised to receive a standard splint or dummy splint.

If they are not sure, or need more time to decide, they will be able to take all the information home and will be contacted the next day for their decision.

This is to ensure that treatment is started as soon as possible regardless of whether they are involved in the trial or not.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Previous wrist or hand surgery
2. Severe deformity of the wrist or hand
3. Previous injury or fracture of the wrist or hand and disease duration < 1 year.

Recruitment start date

28/02/2006

Recruitment end date

14/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St George's NHS Trust
London
SW17 0QT
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

St George's Healthcare NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

No External Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/10/2016: No publications found, verifying study status with principal investigator