Tennis Elbow Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2008-12-31

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.

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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.

Conditions

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Lateral Epicondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Eccentric exercise

Group exposed to eccentric exercise treatment

Group Type EXPERIMENTAL

Eccentric exercise

Intervention Type PROCEDURE

Eccentric exercise treatment performed at home with three sets of 15 repetitions daily

Concentric exercise

Group exposed to concentric exercise treatment

Group Type ACTIVE_COMPARATOR

Concentric exercise

Intervention Type PROCEDURE

Concentric exercise treatment at home with three sets of 15 repetitions daily

Interventions

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Eccentric exercise

Eccentric exercise treatment performed at home with three sets of 15 repetitions daily

Intervention Type PROCEDURE

Concentric exercise

Concentric exercise treatment at home with three sets of 15 repetitions daily

Intervention Type PROCEDURE

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No