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Tennis Elbow Trial (Epi-X)

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ClinicalTrials.gov Identifier: NCT00888225
Recruitment Status : Completed
First Posted : April 27, 2009
Last Update Posted : April 27, 2009
The Swedish Research Council
Amersham Foundation
Uppsala County Council, Sweden
Information provided by:
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.

Condition or disease Intervention/treatment
Lateral Epicondylitis Procedure: Eccentric exercise Procedure: Concentric exercise

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Chronic Lateral Epicondylitis. A Randomized Controlled Clinical Trial of Two Physical Training Concepts With Special Reference to Etiology and Treatment Effect
Study Start Date : October 2003
Primary Completion Date : January 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Eccentric exercise
Group exposed to eccentric exercise treatment
Procedure: Eccentric exercise
Eccentric exercise treatment performed at home with three sets of 15 repetitions daily
Active Comparator: Concentric exercise
Group exposed to concentric exercise treatment
Procedure: Concentric exercise
Concentric exercise treatment at home with three sets of 15 repetitions daily

Primary Outcome Measures :
  1. Pain during dynamic and static muscle load [ Time Frame: Month 0, 1, 2, 3, 6, 12 ]

Secondary Outcome Measures :
  1. Muscle strength and function [ Time Frame: Month 0, 1, 2, 3, 6, 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888225

Linköping University
Linköping, Sweden, SE-58183
Uppsala University, Dept of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology Section
Uppsala, Sweden, SE-75185
Sponsors and Collaborators
Uppsala University
The Swedish Research Council
Amersham Foundation
Uppsala County Council, Sweden
Principal Investigator: Kurt Svärdsudd, MD, PhD Uppsala University

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kurt Svärdsudd, professor, section head, Uppsala University
ClinicalTrials.gov Identifier: NCT00888225     History of Changes
Other Study ID Numbers: VR K2005
First Posted: April 27, 2009    Key Record Dates
Last Update Posted: April 27, 2009
Last Verified: April 2009

Keywords provided by Uppsala University:
Tennis elbow
Muscle strength
Quality of life
Chronic tennis elbow

Additional relevant MeSH terms:
Tennis Elbow
Elbow Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries