Skip to main content
OpenTrials
Completed

NCT Number: NCT00888225

Tennis Elbow Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linköping University, Linköping, Sweden

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eccentric exercise

Procedure

Eccentric exercise treatment performed at home with three sets of 15 repetitions daily

Concentric exercise

Procedure

Concentric exercise treatment at home with three sets of 15 repetitions daily

Primary outcomes

  1. Pain during dynamic and static muscle load

    Time frame: Month 0, 1, 2, 3, 6, 12

Secondary outcomes

  1. Muscle strength and function

    Time frame: Month 0, 1, 2, 3, 6, 12

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Amersham Foundation
  • The Swedish Research Council
  • Uppsala County Council, Sweden

Registry information

Official study title

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

Acronym: Epi-X

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Apr 27, 2009
Registry last updated
Apr 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.