Tennis Elbow Trial

Not Applicable

Completed

• Conditions: Lateral Epicondylitis
• Interventions: Procedure: Eccentric exercise; Procedure: Concentric exercise

• Registration Number: NCT00888225
• Lead Sponsor: Uppsala University

Brief Summary

Epi-X is a multicentered randomized controlled clinical trial of chronic lateral epicondylitis with parallel group design and two phases. In the first phase physical exercise treatment is given in the intervention group and expectance in the reference group. In phase 2 eccentric exercise versus concentric is tested.

Detailed Description

Chronic lateral epicondylitis is defined as the presence of a "tennis elbow" for more than 3 months. It is a common condition in the general population and often results in long-term sick-leave. The etiology is unknown. A large number of treatments have been tried but none is generally accepted. However, in Achilles tendinitis a new treatment has been shown effective. It consists of eccentric exercise, i.e. work during stretching rather than shortening of the muscle (concentric exercise). The latter is currently the most common treatment method.

This project is a randomised controlled clinical trial of eccentric versus concentric exercise in 205 patients with chronic lateral epicondylitis. Pain and muscle strength were recorded at start of treatment and after 1,2,3,6 and 12 months. Activities of daily life (ADL) and well-being were recorded at start of treatment and after 3, 6 and 12 months. In addition, blood specimens for a number of neural peptides have been sampled. Moreover, the involvement of the peripheral nervous system in the elbow area has been examined in a subsample of patients. A biopsy from 20 patients per treatment group and from 20 healthy subjects, and a positron emission tomography (PET) scan of 23 patients were performed to allow qualitative and quantitative examination of neural fibres, peptides and receptors. The health economy of the two treatments will be investigated using data from this project and from available registers.

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2008-01
• Study Completion: 2008-12
• Status Verified: 2009-04
• Study First Submitted: 2009-04-24
• Study First Submitted QC: 2009-04-24
• Last Update Submitted: 2009-04-24
• Study First Posted: 2009-04-27
• Last Update Posted: 2009-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

• Verified tennis elbow for more than three months
• Age 20-75 years
• Informed consent

Exclusion Criteria

• Inability to understand or follow instructions
• Inability to read or fill in questionnaires
• Inability to participate at measurement sessions
• Supinator syndrome
• Compartment syndrome of anconeus muscle
• Rhizopathy of arm
• Inflammatory joint or soft tissue disease including fibromyalgia
• Previous surgery because of tennis elbow

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eccentric exercise	Eccentric exercise	Group exposed to eccentric exercise treatment
Concentric exercise	Concentric exercise	Group exposed to concentric exercise treatment

Primary Outcome Measures

Name	Time	Method
Pain during dynamic and static muscle load	Month 0, 1, 2, 3, 6, 12

Secondary Outcome Measures

Name	Time	Method
Muscle strength and function	Month 0, 1, 2, 3, 6, 12

Trial Locations

Locations (2)

Linköping University; 🇸🇪 Linköping, Sweden

Uppsala University, Dept of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology Section; 🇸🇪 Uppsala, Sweden