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

Tracking Information

First Received Date ^ICMJE

April 24, 2009

Last Updated Date

April 24, 2009

Start Date ^ICMJE

October 2003

Primary Completion Date

January 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Not Provided

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

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

Enrollment ^ICMJE

205

Completion Date

December 2008

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

Sexes Eligible for Study:

All

Ages

20 Years to 75 Years (Adult, Senior)

Accepts Healthy Volunteers

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

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Kurt Svärdsudd, professor, section head, Uppsala University

Study Sponsor ^ICMJE

Uppsala University

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

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