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
Protocol serial number	N0082185031
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funders	Hounslow Primary Care Trust, NHS R&D Support Funding

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

Hand Injuries Unit
'O' Block Therapy Centre
West Middlesex University Hospital
Twickenham Rd
Isleworth
TW7 6AF
United Kingdom

Phone	+44 (0)20 8630 3616
Email	abc@email.com

Study information

Primary study design	Interventional
Study design	Randomised controlled pilot study
Secondary study design	Randomised controlled trial
Study type	Participant 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(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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/06/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

United Kingdom
England

Study participating centre

West Middlesex University Hospital

Isleworth
TW7 6AF
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes