Clinical trial NCT00888225: Tennis Elbow Trial
Official title: Chronic Lateral Epicondylitis. A Randomized Controlled Clinical Trial of Two Physical Training Concepts With Special Reference to Etiology and Treatment Effect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: Tennis elbow
Epicondylitis
Pain
Muscle strength
Quality of life
RCT
Tendinitis
Chronic tennis elbow
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: Amersham Foundation
name: Uppsala County Council, Sweden
First posted: 2009-04-27
Enrollment: 205
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain during dynamic and static muscle load
timeFrame: Month 0, 1, 2, 3, 6, 12
Secondary outcomes:
measure: Muscle strength and function
timeFrame: Month 0, 1, 2, 3, 6, 12
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University
city: Uppsala
country: Sweden
facility: Uppsala University, Dept of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology Section
Study officials:
affiliation: Uppsala University
name: Kurt Svärdsudd, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.