Tennis Elbow Trial (Epi-X)

This study has been completed.
Sponsor:
Collaborators:
The Swedish Research Council
Amersham Foundation
Uppsala County Council, Sweden
Information provided by:
Uppsala University
ClinicalTrials.gov Identifier:
NCT00888225
First received: April 24, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted

April 24, 2009
April 24, 2009
October 2003
January 2008   (final data collection date for primary outcome measure)
Pain during dynamic and static muscle load [ Time Frame: Month 0, 1, 2, 3, 6, 12 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Muscle strength and function [ Time Frame: Month 0, 1, 2, 3, 6, 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Tennis Elbow Trial
Chronic Lateral Epicondylitis. A Randomized Controlled Clinical Trial of Two Physical Training Concepts With Special Reference to Etiology and Treatment Effect

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Lateral Epicondylitis
  • Procedure: Eccentric exercise
    Eccentric exercise treatment performed at home with three sets of 15 repetitions daily
  • Procedure: Concentric exercise
    Concentric exercise treatment at home with three sets of 15 repetitions daily
  • Experimental: Eccentric exercise
    Group exposed to eccentric exercise treatment
    Intervention: Procedure: Eccentric exercise
  • Active Comparator: Concentric exercise
    Group exposed to concentric exercise treatment
    Intervention: Procedure: Concentric exercise

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
205
December 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00888225
VR K2005
No
Kurt Svärdsudd, professor, section head, Uppsala University
Uppsala University
  • The Swedish Research Council
  • Amersham Foundation
  • Uppsala County Council, Sweden
Principal Investigator: Kurt Svärdsudd, MD, PhD Uppsala University
Uppsala University
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP