Condition category
Musculoskeletal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
29/04/2015
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

Mr J Holmes

ORCID ID

Contact details

Derby Hospitals NHS Foundation Trust
Pulvertaft Hand Centre
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0077170554

Study information

Scientific title

A randomised trial to compare the impact of the McKenna thumb shield and Colditz splints upon functional ability and pain levels of patients with osteoarthritis of the first carpometacarpal joint

Acronym

Study hypothesis

1. Establish the short and longer term (12 months) effect of the Colditz and McKenna Thumb Shield splints on pain and function for patients with symptomatic OA at base of thumb.
2. Compare the results of above to determine whether the Colditz or McKenna Thumb Shield is more effective at reducing pain and increasing function.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Musculoskeletal Diseases: Osteoarthritis

Intervention

Patients, referred by the GP, who attend the Pulvertaft Hand Centre at the Derbyshire Royal Infirmary (DRI), presenting with pain and/or instability at the basal thumb joint resulting from osteoarthritis.

The patients will be screened and have an x-ray, as normal, in the Pulvertaft Hand Clinic by a Consultant or Specialist Registrar. The Doctor will then grade the stage of the osteoarthritis by using the Eaton Littler scale. If appropriate they will then be referred onto the occupational therapist or physiotherapist for further assessment and treatment as normal.

The Occupational Therapist in the clinic will receive the referral and then pass it onto the research Occupational Therapist. The research therapist will explain to the patient what is involved in the study and will give them a patient information sheet to take home and read. The research therapist will arrange to phone the patient within 2-3 days to check if they have any queries about the study and to see if they would like to participate. If the patient does not wish to participate, treatment will be organised as normal. For those patients happy to take part in the study, an appointment will be made to obtain written consent and carry out the initial assessment. It will be made clear to the patient that they may withdraw from the study at any time.

Prior to the appointment, the medical notes and x-rays will be obtained to assist in the assessment process. If the patient meets the inclusion criteria the therapist will then go over the patient information about the study again and if the patient is still willing to participate then a consent form will be completed. If consent to participate is not obtained the patient will be treated as normal by the Research Occupational Therapist and then follow up will be arranged with the Hand Therapy workshop team.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

The difference or equivalence of the pain decrease and function increase between the two splinting methods, by comparison of results from the initial assessment, 3 month and 12 month assessments.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2006

Overall trial end date

31/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of osteoarthritis of the first carpometacarpal joint
2. Pain at base of thumb
3. Those who are able to give informed voluntary consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Dislocated basal thumb joint
2. Multiple joint involvement of the hand
3. Neurological disease
4. Rheumatoid arthritis
5. Previous McKenna thumb shield or Colditz splint supplied
6. Those who are unable to give informed voluntary consent

Recruitment start date

01/01/2006

Recruitment end date

31/03/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Derby Hospitals NHS Foundation Trust
Derby
DE1 2QY
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

Derby Hospitals NHS Foundation Trust (UK), 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