Tennis Elbow Trial

Lateral Epicondylitis Clinical Trial

— Epi-X  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888225
• Other study ID #: VR K2005
• Status: Completed
• Phase: N/A
• First received: April 24, 2009
• Last updated: April 24, 2009
• Start date: October 2003
• Est. completion date: December 2008

Study information

• Verified date: April 2009
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: December 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

Procedure:
• Eccentric exercise
Eccentric exercise treatment performed at home with three sets of 15 repetitions daily
• Concentric exercise
Concentric exercise treatment at home with three sets of 15 repetitions daily

Locations

Country	Name	City	State
Sweden	Linköping University	Linköping
Sweden	Uppsala University, Dept of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology Section	Uppsala

Sponsors (4)

Lead Sponsor	Collaborator
Uppsala University	Amersham Foundation, The Swedish Research Council, Uppsala County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain during dynamic and static muscle load		Month 0, 1, 2, 3, 6, 12	No
Secondary	Muscle strength and function		Month 0, 1, 2, 3, 6, 12	No

External Links

•   Uppsala University, Department of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology Section, Sweden