Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Danielle van der Windt

ORCID ID

Contact details

Arthritis Research Campaign National Primary Care Centre
Keele University
Keele
Staffordshire
ST5 5BG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PB-PG-0407-13189

Study information

Scientific title

Improving the effectiveness of pain relief for tennis elbow in Primary Care: the use of transcutaneous electrical nerve stimulation (TENS) for the management of tennis elbow

Acronym

TATE

Study hypothesis

This study will test whether the addition of transcutaneous electrical nerve stimulation (TENS) to advice and exercise in patients who consult their GP with tennis elbow is more effective than advice and exercise alone for reducing pain.

Ethics approval

To be submitted to South Staffordshire Research Ethics Committee on 1st April 2009.

Study design

Single centre pragmatic randomised controlled trial

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

Tennis elbow

Intervention

Primary care management alone (control intervention):
A study clinician (nurse or physiotherapist) trained to deliver the study interventions will provide patients with the tennis elbow information leaflet and will reinforce the messages on advice, and education contained within. Patients will be informed of the usually self-limiting nature of tennis elbow and advised that while the elbow pain persists, they should avoid repetitive elbow extension, forceful elbow activities or activities that provoke pain wherever possible. Potential ergonomic impact factors derived from sporting or working activities will be discussed and self-management in the form of rest/avoidance suggested, although absolute rest of the arm will not be advocated. In addition, the patient will be advised to gradually increase activity once acute pain has settled down and some basic progressive exercises will be explained.

Primary care management plus patient-controlled TENS:
In addition to the control intervention described above, patients will be given a TENS machine and instructed on how to use it. They will be shown how to apply the TENS locally, to the lateral aspect of the elbow and forearm and will be encouraged to use the TENS machine at least once per day for a 30 - 45 minute treatment session for each day that symptoms persist. Patients may use the TENS machine more often if they wish. The TENS parameter settings will be high frequency (110 Hz) pulse duration of 200 ms (frequency and pulse duration will be pre-programmed) with a self-selected intensity described as of strong but tolerable sensation (measured as amplitude mA). Patients will be informed that they should experience an uncomfortable (but not painful) ‘tingling’ sensation and that they may experience muscle contractions and a local cooling of the area. Patients will be encouraged to use the TENS machine for a minimum of six weeks unless their symptoms have fully resolved before then.

All patients will attend one appointment to receive the study intervention from the treating clinician and then self-manage their treatment for up to six weeks depending on symptoms.

Baseline questionnaires will be completed after written informed consent and before randomisation. Follow up will be by postal questionnaires at 6 weeks, 6 months and 12 months. Patients will also be given a 14 -day daily diary to complete after their clinic attendance and return to the research centre on completion.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The average intensity of elbow pain over the past 24 hours measured using a numerical rating scale (NRS) (where 0 = no pain and 10 = worst pain imaginable). This measure will be collected at baseline, and postal questionnaires at 6 and 12 months as well as at 6 weeks and in the daily diary.

Secondary outcome measures

1. Pain and limitation in function (Patient-rated Tennis Elbow Evaluation (PTEE)
2. Days sick leave and ability to carry out usual activities
3. Self reported global change in elbow pain (5-point adjectival scale: much better - much worse
4. Illness Perception Questionnaire short-form (IPQ-R)
5. General Health: the EuroQoL EQ-5D, 12-item short form (SF-12) and 6-dimensions short form (SF-6D)
6. Health care resource use (including visits to health care professionals, and use of co-interventions and analgesics)
7. Beliefs and expectations of treatment (IPQ-R and specific items)
8. Satisfaction with treatment, feasibility, and applicability of TENS (0-10 NRS), measured with daily diary and 6-week follow up
9. Compliance with treatment (adherence to advice/exercise, and use of TENS in minutes per day in the TENS group), measured with daily diary and 6-week questionnaire

Overall trial start date

15/05/2009

Overall trial end date

30/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults aged 18 years and over, either sex
2. Consult their GP with a new episode of tennis elbow (i.e. adults with pain and tenderness in the lateral region of the elbow, increasing on pressure on the lateral epicondyle and on resisted dorsiflexion of the wrist)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

Participant exclusion criteria

1. A history of inflammatory arthritis or gross structural abnormality of the elbow
2. Contraindications to TENS (pacemakers, epilepsy, dermatological conditions, abnormal sensation in the affected arm, indwelling electrical pumps/pacemakers and pregnancy)
3. Neuropathic pain
4. Inability to independently apply TENS, complete written questionnaires, or read instruction leaflets written in English

Recruitment start date

15/05/2009

Recruitment end date

30/06/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Arthritis Research Campaign National Primary Care Centre
Staffordshire
ST5 5BG
United Kingdom

Sponsor information

Organisation

Keele University (UK)

Sponsor details

c/o Professor Peter Croft
Institute of Primary Care Sciences
Keele
Staffordshire
ST5 5BG
United Kingdom

Sponsor type

University/education

Website

http://www.keele.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) (ref: PB-PG-0407-13189)

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

2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20003341
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23999980

Publication citations

  1. Protocol

    Chesterton LS, van der Windt DA, Sim J, Lewis M, Mallen CD, Mason EE, Warlow C, Vohora K, Hay EM, Transcutaneous electrical nerve stimulation for the management of tennis elbow: a pragmatic randomized controlled trial: the TATE trial (ISRCTN 87141084)., BMC Musculoskelet Disord, 2009, 10, 156, doi: 10.1186/1471-2474-10-156.

  2. Results

    Chesterton LS, Lewis AM, Sim J, Mallen CD, Mason EE, Hay EM, van der Windt DA, Transcutaneous electrical nerve stimulation as adjunct to primary care management for tennis elbow: pragmatic randomised controlled trial (TATE trial)., BMJ, 2013, 347, f5160.

Editorial Notes