Tennis Elbow Trial (Epi-X)

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 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 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	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 *	Peterson M, Svärdsudd K, Appel L, Engler H, Aarnio M, Gordh T, Långström B, Sörensen J. PET-scan shows peripherally increased neurokinin 1 receptor availability in chronic tennis elbow: visualizing neurogenic inflammation? PLoS One. 2013 Oct 14;8(10):e75859. doi: 10.1371/journal.pone.0075859. eCollection 2013.; Peterson M, Butler S, Eriksson M, Svärdsudd K. A randomized controlled trial of exercise versus wait-list in chronic tennis elbow (lateral epicondylosis). Ups J Med Sci. 2011 Nov;116(4):269-79. doi: 10.3109/03009734.2011.600476.
* 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	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	Sexes Eligible for Study: All
Ages	20 Years to 75 Years (Adult, Senior)
Accepts Healthy Volunteers	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	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