Condition category
Musculoskeletal Diseases
Date applied
26/01/2012
Date assigned
08/03/2012
Last edited
08/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Andrew Toms

ORCID ID

Contact details

Royal Devon & Exeter NHS Foundation NHS Trust
Barrack Road
Exeter
EX2 5DW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

"Tenease" - can localised vibration therapy reduce the pain associated with tennis elbow? A pilot randomised controlled trial

Acronym

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

NRES Committee South West - Exeter, 26 September 2011 ref: 11/SW/0190

Study design

Pilot single centre randomised study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/02/2012

Overall trial end date

01/02/2014

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

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

United Kingdom

Trial participating centre

Royal Devon & Exeter NHS Foundation NHS Trust
Exeter
EX2 5DW
United Kingdom

Sponsor information

Organisation

Royal Devon & Exeter NHS Foundation Trust (UK)

Sponsor details

Barrack Road
Exeter
EX2 5DW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.rdehospital.nhs.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

Royal Devon & Exeter NHS Foundation Trust (UK) ref: AT/28/7/11

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

08/08/21016: No publications found in PubMed, verifying study status with principal investigator.