| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN36694296 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0082185031 |
| Public title | A pilot study comparing the effectiveness of two methods of immobilisation in the treatment of de Quervain's disease |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Musculoskeletal Diseases: De Quervain's disease |
| Study hypothesis | 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. |
| Design/methodology | Randomised controlled pilot study |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Thirty patients who have been diagnosed as having de Quervain's disease. |
| Participants - 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. |
| Patient information material |
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| Anticipated start date | 01/09/2006 |
| Anticipated end date | 01/06/2007 |
| Status of trial | Completed |
| Target number of participants | 30 |
| Interventions | 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. |
| Primary outcome measure(s) | 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 measure(s) | Not provided at time of registration |
| Sources of funding | Hounslow Primary Care Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Miss Cara Easton |
| Contact details | Hand Injuries Unit
'O' Block Therapy Centre
West Middlesex University Hospital
Twickenham Rd
Isleworth
United Kingdom
TW7 6AF |
| Contact telephone | +44 020 8630 3616 |
| Contact fax | +44 020 8630 3478 |
| Contact email | cara.easton@hounslowpct.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN36694296 |
| Date last extracted from ISRCTN register | 17/04/2008 |
