A prospective, comparative analysis of commercial and customised thumb splints in osteoarthritis effects on pain, hand function and patient preference.

ISRCTN ISRCTN53731769
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

Occupational Therapy Department
Level 07
Derriford Hospital
Derriford
Plymouth
PL6 8DH
United Kingdom

Study information

Study designProspective, longitudinal study with a randomised cross over design
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesOsteoarthritis 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) studiedMusculoskeletal Diseases: Osteoarthritis (OA)
InterventionAt 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 typeOther
Primary outcome measurePain 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 measuresNot provided at time of registration
Overall study start date10/09/2002
Completion date20/04/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment10/09/2002
Date of final enrolment20/04/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Occupational Therapy Department
Plymouth
PL6 8DH
United Kingdom

Sponsor information

Department of Health
Government

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

Plymouth Hospitals NHS Trust (UK), Own Account

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