Tennis Elbow Trial (Epi-X)

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

Tracking Information

• First Submitted Date: April 24, 2009
• First Posted Date: April 27, 2009
• Last Update Posted Date: April 27, 2009
• Study Start Date: October 2003
• Actual Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 24, 2009): Pain during dynamic and static muscle load [ Time Frame: Month 0, 1, 2, 3, 6, 12 ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: April 24, 2009): Muscle strength and function [ Time Frame: Month 0, 1, 2, 3, 6, 12 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Tennis Elbow Trial
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Lateral Epicondylitis

Intervention

• 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, Svardsudd K, Appel L, Engler H, Aarnio M, Gordh T, Langstrom B, Sorensen 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, Svardsudd 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 24, 2009): 205
• Original Actual Enrollment: 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

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, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT00888225
• Other Study ID Numbers: VR K2005
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Kurt Svärdsudd, professor, section head, Uppsala University
• Original Responsible Party: Same as current
• Current Study Sponsor: Uppsala University
• Original Study Sponsor: Same as current

Collaborators

• The Swedish Research Council
• Amersham Foundation
• Uppsala County Council, Sweden

Investigators

• Principal Investigator: Kurt Svärdsudd, MD, PhD; Uppsala University

• PRS Account: Uppsala University
• Verification Date: April 2009