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
Protocol serial number	N0185146346
Sponsor	Department of Health
Funder	Plymouth Hospitals NHS Trust (UK), Own Account

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

Primary study design	Interventional
Study design	Prospective, longitudinal study with a randomised cross over design
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	20/04/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
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

United Kingdom
England

Study participating centre

Occupational Therapy Department

Plymouth
PL6 8DH
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