| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN34475330 |
| Date ISRCTN assigned | 12/09/2003 |
| Local reference number(s) | N0544103837 |
| Public title | Ultrasound therapy for lateral epicondylitis. A double blind randomised placebo controlled trial |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Musculoskeletal Diseases: Lateral epicondylitis (tennis elbow) |
| Study hypothesis | Ultrasound therapy for lateral epicondylitis |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 200 18-75 year olds (PROJ) |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 11/09/2000 |
| Anticipated end date | 11/09/2003 |
| Status of trial | Completed |
| Target number of participants | 200 |
| Interventions | To evaluate the effects of ultrasound in the treatment of lateral epicondylitis. Adult subjects with lateral epicondylitis will be randomised to receive either ultrasound (US) or sham (S) therapy. In the US group pulsed ultrasound will be delivered at a standardised dosage, initially five times weekly for 3 weeks, then three times weekly for 3 weeks. A single machine will be used and calibrated twice daily. The patient, assessor and treating clinician will be blinded. Outcome measures will be recorded at 6 weeks and at 9 months from baseline. These will include a forearm evaluation score and pain (primary measures), grip strength, flexibility, inflammation (thermographic score), quality of life and general health status, a summary item of status of the injury and a follow up transition item. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cambridge Consortium - Addenbrookes |
| Sponsor name | Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK) |
| 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 (0)20 7307 2623 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.doh.gov.uk |
| Contact name | Dr Cathy Speed |
| Contact details | Box No 204
Department of Rheumatology
Addenbrooke's NHS Trust
Hills Road
Cambridge
United Kingdom
CB2 2QQ |
| Contact telephone | +44 01223 586518 |
| Contact fax | +44 |
| Contact email | cas50@medschl.cam.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN34475330 |
| Date last extracted from ISRCTN register | 17/04/2008 |
