"Tenease" - a new treatment for tennis elbow
| ISRCTN | ISRCTN92449236 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92449236 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/01/2012
- Registration date
- 08/03/2012
- Last edited
- 21/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Tennis elbow is a painful condition of the elbow that is both common and debilitating. We are investigating a new type of treatment called Tenease. It is a small device that straps onto the elbow and is worn for a short period each day.
Who can participate?
People over 18 years old who have a new diagnosis of tennis elbow from their GP.
What does the study involve?
Participants will be randomly allocated to receive either the standard treatment for tennis elbow (painkillers etc) for 6 weeks, or the standard treatment and a Tenease unit. We can then see if there is any difference between the two groups. We will be following patients for a year to see if any differences last.
What are the possible benefits and risks of participating?
Participants may experience an improvement in their symptoms.
Where is the study run from?
Royal Devon & Exeter NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
February 2012 to February 2014
Who is funding the study?
Royal Devon & Exeter NHS Foundation Trust (UK)
Who is the main contact?
Mr Andrew Toms
Contact information
Scientific
Royal Devon & Exeter NHS Foundation NHS Trust
Barrack Road
Exeter
EX2 5DW
United Kingdom
Study information
| Study design | Pilot single centre randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | "Tenease" - can localised vibration therapy reduce the pain associated with tennis elbow? A pilot randomised controlled trial |
| Study hypothesis | Null hypothesis: The Tenease therapy will provide no extra benefit in the treatment of Lateral Epicondyle Tendonopathy (LET) that routine treatment from the General Practitioner alone. Analysis of the pilot study data will allow us to perform a power calculation for a larger randomised controlled study. |
| Ethics approval(s) | NRES Committee South West - Exeter, 26 September 2011 ref: 11/SW/0190 |
| Condition | Lateral epicondyle tendonopathy |
| Intervention | Tenease (vibration therapy unit) and conventional Tennis Elbow treatment (analgesia and activity modification) versus. conventional treatment alone. Duration of treatment 6 weeks, follow up 12 months. |
| Intervention type | Other |
| Primary outcome measure | Average intensity of pain in the elbow over 24 hours, at 6 weeks from commencement of treatment |
| Secondary outcome measures | 1. Grip strength 2. Pain 3. Limitation of function 4. Global assessment of change 5. Days of sick leave 6. Overall health status |
| Overall study start date | 01/02/2012 |
| Overall study end date | 01/02/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Participant inclusion criteria | 1. Male and female 2. Over 18 years old 3. Consulting their GP with a first diagnosis of lateral epicondyle tendonopathy 4. Diagnosis will be made clinically by the GP 5. Diagnosed with the following symptoms: 5.1. Pain on the lateral elbow that radiates down the forearm 5.2. Point tenderness over the origin of the extensor muscles or at its close proximity (within 2.5cm) 5.3. Pain on resisted extension of the wrist 5.4. Pain on resisted extension of the middle finger 6. Patients must speak English, be willing to take part and able to consent to the trial |
| Participant exclusion criteria | 1. Concomitant inflammatory arthritides 2. Structural abnormality of the elbow 3. Unable to comprehend the instructions of the Tenease unit 4. Unable to apply the unit correctly |
| Recruitment start date | 01/02/2012 |
| Recruitment end date | 01/02/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
EX2 5DW
United Kingdom
Sponsor information
Hospital/treatment centre
Barrack Road
Exeter
EX2 5DW
England
United Kingdom
| Website | http://www.rdehospital.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/03085z545 |
Funders
Funder type
Hospital/treatment centre
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 | 01/09/2018 | 21/01/2019 | Yes | No |
Editorial Notes
21/01/2019: Publication reference added
08/08/21016: No publications found in PubMed, verifying study status with principal investigator.
