Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Miss Cara Easton


Contact details

Hand Injuries Unit
'O' Block Therapy Centre
West Middlesex University Hospital
Twickenham Rd
United Kingdom
+44 (0)20 8630 3616

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A pilot study comparing the effectiveness of two methods of immobilisation in the treatment of 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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled pilot study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Musculoskeletal Diseases: De Quervain's disease


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



Not Specified

Drug names

Primary outcome measures

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 trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

Thirty patients who have been diagnosed as having de Quervain's disease

Participant type


Age group

Not Specified


Not Specified

Target number of participants


Participant 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.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

West Middlesex University Hospital
United Kingdom

Sponsor information


Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
United Kingdom
+44 (0)20 7307 2622

Sponsor type




Funder type


Funder name

Hounslow Primary Care Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype


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