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Tennis Elbow Trial (Epi-X)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00888225
Recruitment Status : Completed
First Posted : April 27, 2009
Last Update Posted : April 27, 2009
Sponsor:
Collaborators:
The Swedish Research Council
Amersham Foundation
Uppsala County Council, Sweden
Information provided by:
Uppsala University

Tracking Information
First Submitted Date  ICMJE April 24, 2009
First Posted Date  ICMJE April 27, 2009
Last Update Posted Date April 27, 2009
Study Start Date  ICMJE October 2003
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2009)
Pain during dynamic and static muscle load [ Time Frame: Month 0, 1, 2, 3, 6, 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2009)
Muscle strength and function [ Time Frame: Month 0, 1, 2, 3, 6, 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tennis Elbow Trial
Official Title  ICMJE Chronic Lateral Epicondylitis. A Randomized Controlled Clinical Trial of Two Physical Training Concepts With Special Reference to Etiology and Treatment Effect
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Lateral Epicondylitis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2009)
205
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00888225
Other Study ID Numbers  ICMJE VR K2005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Kurt Svärdsudd, professor, section head, Uppsala University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Uppsala University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • The Swedish Research Council
  • Amersham Foundation
  • Uppsala County Council, Sweden
Investigators  ICMJE
Principal Investigator: Kurt Svärdsudd, MD, PhD Uppsala University
PRS Account Uppsala University
Verification Date April 2009

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