A pilot study comparing the effectiveness of two methods of immobilisation in the treatment of de Quervain's disease
| ISRCTN | ISRCTN36694296 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36694296 |
| Secondary identifying numbers | N0082185031 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 02/09/2015
- 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 Cara Easton
Scientific
Scientific
Hand Injuries Unit
'O' Block Therapy Centre
West Middlesex University Hospital
Twickenham Rd
Isleworth
TW7 6AF
United Kingdom
| Phone | +44 (0)20 8630 3616 |
|---|---|
| abc@email.com |
Study information
| Study design | Randomised controlled pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A pilot study comparing the effectiveness of two methods of immobilisation in the treatment of de Quervain's disease |
| Study objectives | The principal objective is to establish if increasing compliance with an immobilisation technique (by comparing removable and non-removable techniques) will produce a better clinical outcome. The hypothesis is that by reducing patients' ability to be 'non-compliant' to the splinting regime, and immobilising the hand and wrist in a non-removable cast, the number of patients reporting ongoing symptoms at 6 week review will decrease, and the need for further immobilisation and referral for steroid injection will be reduced. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: De Quervain's disease |
| Intervention | The study consists of a pre-test post-test design, with a sample of thirty patients referred for assessment to the Hand Injuries Unit at the West Middlesex University Hospital Therapy Centre, and who are subsequently diagnosed to have de Quervain's disease. The sample will be randomised into a treatment group of 15, for each of whom a 'non-removable' cast for hand and wrist will be applied, and a control group of 15, for each of whom a thermoplastic removable splint will be applied. Prior to immobilisation, each patient will be assessed by means of the 'Disability of the Arm and Shoulder' (DASH) assessment questionnaire, a pain scale, Finkenstein's test and the Jebsen Hand Function test. The same measures will be applied to each patient after a period of six weeks immobilisation is complete, when either the 'non-removable' cast or the thermoplastic splint, depending on which group the patient has been randomised into, will be removed. Additionally, all participants will be interviewed at 12 weeks after they enter the study and begin treatment, by a research assistant about their treatment experience and experience following treatment. The research assistant will be blinded to the treatment received by the participant and to their results. |
| Intervention type | Other |
| Primary outcome measure | 1. Disability of the Arm Shoulder and Hand - measures subjective bilateral function in the upper limb in the week preceding its completion 2. Pain assessment with a modified McGill pain questionnaire, combining a visual analogue scale, word descriptors and body map indicators 3. Jebsen Hand Function test - testing gross functional dexterity 4. Finkelstein's test , of the affected tendons - indicating de Quervain's 5. Interview of participants about compliance, pain, functional impairment and treatment preferences |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2006 |
| Completion date | 01/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 30 |
| Key inclusion criteria | Thirty patients who have been diagnosed as having de Quervain's disease |
| Key exclusion criteria | 1. Patients who have already received invasive treatment including steroid injections or surgery to the first dorsal compartment of the affected hand for de Quervain's disease. These patients have already received invasive treatment and therefore conservative management is less likely to be effective. By excluding these patients we will be reducing any influencing variables and ensuring that only the effectiveness of immobilisation is being studied. 2. Patients who display a positive grind test for 1st CMC joint osteoarthritis. The nature and cause of pain in patients with a positive grind test is likely to be due to osteoarthritis of the joint and not de Quervain's disease. 3. Patients with a negative Finkelsteins test or whose pain during the test is not localised to the first dorsal compartment - as this is a diagnostic tool patients who do not display a positive Finkelsteins test are unlikely to have de Quervain's disease. 4. Patients who are unable to give informed consent or comply with the treatment regime will be excluded from this study. Hounslow PCT requires all patients to give informed consent and as this study requires participants to adhere to a protocol, all patients who are unable to do so will be excluded. 5. Patients not registered with a General Practitioner (GP). The Hand Injuries Unit requires that all patient referred to the unit are registered with a GP. This allows handover of duty of care to occur when treatment is completed. Patients who are not registered with a GP will not be assessed or receive treatment from the Hand Injuries Unit until they are registered. |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 01/06/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
West Middlesex University Hospital
Isleworth
TW7 6AF
United Kingdom
TW7 6AF
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Hounslow Primary Care Trust
No information available
NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
