Tennis Elbow Trial (Epi-X)
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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 |
- Pain during dynamic and static muscle load [ Time Frame: Month 0, 1, 2, 3, 6, 12 ] [ Designated as safety issue: No ]
- 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 |
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| 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 | |
| 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 Musculoskeletal Diseases Arm Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013