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
  Purpose

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 Intervention
Lateral Epicondylitis
Procedure: Eccentric exercise
Procedure: Concentric exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Pain during dynamic and static muscle load [ Time Frame: Month 0, 1, 2, 3, 6, 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Muscle strength and function [ Time Frame: Month 0, 1, 2, 3, 6, 12 ] [ Designated as safety issue: No ]

Enrollment: 205
Study Start Date: October 2003
Study Completion Date: December 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888225

Locations
Sweden
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
Investigators
Principal Investigator: Kurt Svärdsudd, MD, PhD Uppsala University
  More Information

Additional Information:
No publications provided by Uppsala University

Additional 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
Study First Received: April 24, 2009
Last Updated: April 24, 2009
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Uppsala University:
Tennis elbow
Epicondylitis
Pain
Muscle strength
Quality of life
RCT
Tendinitis
Chronic tennis elbow

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

ClinicalTrials.gov processed this record on October 30, 2014