Tennis Elbow Trial (Epi-X)
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ClinicalTrials.gov Identifier: NCT00888225 |
Recruitment Status :
Completed
First Posted : April 27, 2009
Last Update Posted : April 27, 2009
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Tracking Information | ||||
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First Submitted Date ICMJE | April 24, 2009 | |||
First Posted Date ICMJE | April 27, 2009 | |||
Last Update Posted Date | April 27, 2009 | |||
Study Start Date ICMJE | October 2003 | |||
Actual Primary Completion Date | January 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Pain during dynamic and static muscle load [ Time Frame: Month 0, 1, 2, 3, 6, 12 ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
Muscle strength and function [ Time Frame: Month 0, 1, 2, 3, 6, 12 ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Tennis Elbow Trial | |||
Official Title ICMJE | Chronic Lateral Epicondylitis. A Randomized Controlled Clinical Trial of Two Physical Training Concepts With Special Reference to Etiology and Treatment Effect | |||
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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE | Lateral Epicondylitis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
205 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | December 2008 | |||
Actual Primary Completion Date | January 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Sweden | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00888225 | |||
Other Study ID Numbers ICMJE | VR K2005 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Kurt Svärdsudd, professor, section head, Uppsala University | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Uppsala University | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Uppsala University | |||
Verification Date | April 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |