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 |
| Protocol serial number | N0077170554 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding |
- 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
Scientific
Derby Hospitals NHS Foundation Trust
Pulvertaft Hand Centre
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 31/03/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Derby Hospitals NHS Foundation Trust
Derby
DE1 2QY
United Kingdom
DE1 2QY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
