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

ISRCTN ISRCTN77716513
DOI https://doi.org/10.1186/ISRCTN77716513
Secondary identifying numbers N0077170554
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
29/04/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr J Holmes
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA 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
Study objectives1. 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMusculoskeletal Diseases: Osteoarthritis
InterventionPatients, 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 typeProcedure/Surgery
Primary outcome measureThe 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 measuresNot provided at time of registration
Overall study start date01/01/2006
Completion date31/03/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40
Key inclusion criteria1. Diagnosis of osteoarthritis of the first carpometacarpal joint
2. Pain at base of thumb
3. Those who are able to give informed voluntary consent
Key exclusion criteria1. 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
Date of first enrolment01/01/2006
Date of final enrolment31/03/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Derby Hospitals NHS Foundation Trust
Derby
DE1 2QY
United Kingdom

Sponsor information

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan