Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0185146346
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Prospective, longitudinal study with a randomised cross over design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
10/09/2002
Overall trial end date
20/04/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
10/09/2002
Recruitment end date
20/04/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Occupational Therapy Department
Plymouth
PL6 8DH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Plymouth Hospitals NHS Trust (UK), Own Account
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