Tennis Elbow Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Chronic Lateral Epicondylitis. A Randomized Controlled Clinical Trial of Two Physical Training Concepts With Special Reference to Etiology and Treatment Effect

Conditions
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Lateral Epicondylitis

Intervention / Treatment
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* Procedure: Eccentric exercise
* Procedure: Concentric exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eccentric exercise<br>Group exposed to eccentric exercise treatment | Procedure: Eccentric exercise<br>* Eccentric exercise treatment performed at home with three sets of 15 repetitions daily<br>|
| Active Comparator: Concentric exercise<br>Group exposed to concentric exercise treatment | Procedure: Concentric exercise<br>* Concentric exercise treatment at home with three sets of 15 repetitions daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during dynamic and static muscle load |  | Month 0, 1, 2, 3, 6, 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength and function |  | Month 0, 1, 2, 3, 6, 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tennis elbow, Epicondylitis, Pain, Muscle strength, Quality of life, RCT, Tendinitis, Chronic tennis elbow