A prospective, comparative analysis of commercial and customised thumb splints in osteoarthritis effects on pain, hand function and patient preference.
ISRCTN | ISRCTN53731769 |
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DOI | https://doi.org/10.1186/ISRCTN53731769 |
Secondary identifying numbers | N0185146346 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 25/04/2014
- 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
Miss Lisa Vant'Wout
Scientific
Scientific
Occupational Therapy Department
Level 07
Derriford Hospital
Derriford
Plymouth
PL6 8DH
United Kingdom
Study information
Study design | Prospective, longitudinal study with a randomised cross over design |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study objectives | Osteoarthritis of the thumb and splinting: 1. To contrast and compare levels of pain relief and scores on hand functions between the splints 2. To contrast and compare patients views of each splint in terms of pain relief, hand function and cosmesis 3. To compare this to the theoretical basis of splinting, and findings of previous studies in this area 4. To make recommendations for how practice can be improved 5. The null hypothesis is: there is no significant difference between customised and commercial splints with reference to pain levels, hand function and patient preference. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Osteoarthritis (OA) |
Intervention | At the first appointment a Baseline assessment will be carried out , and the patient will be randomly allocated either a hard/ customised or soft/commercial splint, to be worn for two weeks. |
Intervention type | Other |
Primary outcome measure | Pain will be measured using a visual analogue scale, hand function will be assessed using the arthritis hand function test, and patient preference by using a questionnaire. After randomisation, the patients will be reassessed, using the same assessments, with the said splint in situ. At this point they will be given a questionnaire to fill out, at home, within a week. At the third appointment they will be given the second, different type of splint to wear for two weeks. The same procedure of appointments and assessments as for the first splint will be repeated. At the final appointment patients will be asked which splint, if any, they prefer, and they will take this one away with them. Results gained will then be compared and contrasted as set out in the research proposal. |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 10/09/2002 |
Completion date | 20/04/2003 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | Not provided at time of registration |
Key inclusion criteria | Not provided at time of registration |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 10/09/2002 |
Date of final enrolment | 20/04/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Occupational Therapy Department
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Plymouth Hospitals NHS Trust (UK), Own Account
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |