The treatment and advice for tennis elbow study

Completed

Conditions: Tennis elbow
Musculoskeletal Diseases
Other enthesopathies

Registration Number: ISRCTN87141084

Lead Sponsor: Keele University (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 240

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)

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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