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
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