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Tennis Elbow Trial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00888225
Acronym
Epi-X
Enrollment
205
Registered
2009-04-27
Start date
2003-10-31
Completion date
2008-12-31
Last updated
2009-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lateral Epicondylitis

Keywords

Tennis elbow, Epicondylitis, Pain, Muscle strength, Quality of life, RCT, Tendinitis, Chronic tennis elbow

Brief summary

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

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.

Interventions

PROCEDUREEccentric exercise

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

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

Sponsors

The Swedish Research Council
CollaboratorOTHER_GOV
Amersham Foundation
CollaboratorUNKNOWN
Uppsala County Council, Sweden
CollaboratorOTHER_GOV
Uppsala University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
Pain during dynamic and static muscle loadMonth 0, 1, 2, 3, 6, 12

Secondary

MeasureTime frame
Muscle strength and functionMonth 0, 1, 2, 3, 6, 12

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026