Ultrasound therapy for lateral epicondylitis. A double blind randomised placebo controlled trial
| ISRCTN | ISRCTN34475330 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34475330 |
| Secondary identifying numbers | N0544103837 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 06/12/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Cathy Speed
Scientific
Scientific
Box No 204
Department of Rheumatology
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Ultrasound therapy for lateral epicondylitis |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Lateral epicondylitis (tennis elbow) |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 11/09/2000 |
| Completion date | 11/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | 200 18-75 year olds (PROJ) |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 11/09/2000 |
| Date of final enrolment | 11/09/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Box No 204
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Other
Cambridge Consortium - Addenbrooke's (UK)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2006 | Yes | No |
