Ultrasound therapy for medial epicondylitis. A double blind randomised placebo controlled trial.
| ISRCTN | ISRCTN71865873 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71865873 |
| Protocol serial number | N0544093511 |
| Sponsor | Department of Health (UK) |
| Funder | Cambridge Consortium - Addenbrooke's (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 31/10/2019
- 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
Dr Cathy Speed
Scientific
Scientific
Box No 204
Dept of Rheumatology
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Ultrasound therapy for medial epicondylitis. A double blind randomised placebo controlled trial. |
| Study objectives | Ultrasound therapy for medial epicondylitis |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Medial epicondylitis |
| Intervention | To evaluate the effects of ultrasound in the treatment of medial epicondylitis. Adult subjects with medial 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 all 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 11/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Not Specified |
| Target sample size at registration | 200 |
| Key inclusion criteria | 200 Adults aged 18-75 (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
- United Kingdom
- England
Study participating centre
Box No 204
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
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 |
Editorial Notes
31/10/2019: No publications found in PubMed, verifying study status with principal investigator.
13/10/2017: No publications found in PubMed, verifying study status with principal investigator.
