Condition category
Musculoskeletal Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
25/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Lisa Vant'Wout

ORCID ID

Contact details

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

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes