Clinical Trials Directory

Trials / Completed

CompletedNCT00888225

Tennis Elbow Trial

Chronic Lateral Epicondylitis. A Randomized Controlled Clinical Trial of Two Physical Training Concepts With Special Reference to Etiology and Treatment Effect

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
205 (actual)
Sponsor
Uppsala University · Academic / Other
Sex
All
Age
20 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREEccentric exerciseEccentric exercise treatment performed at home with three sets of 15 repetitions daily
PROCEDUREConcentric exerciseConcentric exercise treatment at home with three sets of 15 repetitions daily

Timeline

Start date
2003-10-01
Primary completion
2008-01-01
Completion
2008-12-01
First posted
2009-04-27
Last updated
2009-04-27

Locations

2 sites across 1 country: Sweden

Source: ClinicalTrials.gov record NCT00888225. Inclusion in this directory is not an endorsement.