Tennis Elbow Trial (Epi-X)
Primary Purpose
Lateral Epicondylitis
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Eccentric exercise
Concentric exercise
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Tennis elbow, Epicondylitis, Pain, Muscle strength, Quality of life, RCT, Tendinitis, Chronic tennis elbow
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
Sites / Locations
- Linköping University
- Uppsala University, Dept of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology Section
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Eccentric exercise
Concentric exercise
Arm Description
Group exposed to eccentric exercise treatment
Group exposed to concentric exercise treatment
Outcomes
Primary Outcome Measures
Pain during dynamic and static muscle load
Secondary Outcome Measures
Muscle strength and function
Full Information
NCT ID
NCT00888225
First Posted
April 24, 2009
Last Updated
April 24, 2009
Sponsor
Uppsala University
Collaborators
The Swedish Research Council, Amersham Foundation, Uppsala County Council, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT00888225
Brief Title
Tennis Elbow Trial
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Uppsala University
Collaborators
The Swedish Research Council, Amersham Foundation, Uppsala County Council, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
Tennis elbow, Epicondylitis, Pain, Muscle strength, Quality of life, RCT, Tendinitis, Chronic tennis elbow
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
205 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eccentric exercise
Arm Type
Experimental
Arm Description
Group exposed to eccentric exercise treatment
Arm Title
Concentric exercise
Arm Type
Active Comparator
Arm Description
Group exposed to concentric exercise treatment
Intervention Type
Procedure
Intervention Name(s)
Eccentric exercise
Intervention Description
Eccentric exercise treatment performed at home with three sets of 15 repetitions daily
Intervention Type
Procedure
Intervention Name(s)
Concentric exercise
Intervention Description
Concentric exercise treatment at home with three sets of 15 repetitions daily
Primary Outcome Measure Information:
Title
Pain during dynamic and static muscle load
Time Frame
Month 0, 1, 2, 3, 6, 12
Secondary Outcome Measure Information:
Title
Muscle strength and function
Time Frame
Month 0, 1, 2, 3, 6, 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt Svärdsudd, MD, PhD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linköping University
City
Linköping
ZIP/Postal Code
SE-58183
Country
Sweden
Facility Name
Uppsala University, Dept of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology Section
City
Uppsala
ZIP/Postal Code
SE-75185
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
24155873
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.
Results Reference
derived
PubMed Identifier
22066975
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.
Results Reference
derived
Links:
URL
http://www.pubcare.uu.se
Description
Uppsala University, Department of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology Section, Sweden
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Tennis Elbow Trial
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