Tennis Elbow Trial (Epi-X)
Chronic Lateral Epicondylitis. A Randomized Controlled Clinical Trial of Two Physical Training Concepts With Special Reference to Etiology and Treatment Effect
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Linköping, Sweden, SE-58183
- Linköping University
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Uppsala, Sweden, SE-75185
- Uppsala University, Dept of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology Section
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Eccentric exercise
Group exposed to eccentric exercise treatment
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Eccentric exercise treatment performed at home with three sets of 15 repetitions daily
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Active Comparator: Concentric exercise
Group exposed to concentric exercise treatment
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Concentric exercise treatment at home with three sets of 15 repetitions daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pain during dynamic and static muscle load
Time Frame: Month 0, 1, 2, 3, 6, 12
|
Month 0, 1, 2, 3, 6, 12
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Muscle strength and function
Time Frame: Month 0, 1, 2, 3, 6, 12
|
Month 0, 1, 2, 3, 6, 12
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kurt Svärdsudd, MD, PhD, Uppsala University
Publications and helpful links
General 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VR K2005
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