Effects of Eccentric Training for Patients With Lateral Epicondylalgia

Tracking Information
First Submitted Date ICMJE	September 10, 2009
First Posted Date ICMJE	September 11, 2009
Last Update Posted Date	September 11, 2009
Study Start Date ICMJE	February 2005
Actual Primary Completion Date	May 2005 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 10, 2009)	Diagnostic criteria, whether or not the patient had recovered according to the diagnostic criteria for LE, Haker (1991) at follow up examinations [ Time Frame: 3 wk and 6 wk follow up ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: September 10, 2009)	Measurements of pain free functional grip strength using the Martin Vigorimeter test, and maximum pain free isometric extensor strength by using Nicholas Myometer [ Time Frame: 3 wk and 6 wk follow-up ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effects of Eccentric Training for Patients With Lateral Epicondylalgia
Official Title ICMJE	Effects of Eccentric Training for Patients With Lateral Epicondylalgia - a Randomized Controlled Trial
Brief Summary	The purpose of this study is to evaluate eccentric training as an intervention for lateral epicondylalgia (tennis elbow) in a clinical setting.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
Condition ICMJE	Tennis Elbow; Epicondylitis, Lateral Humeral
Intervention ICMJE	Other: Eccentric training A home training program of eccentric training of the wrist extensors to be carried out daily with 3 sets of 15 repetitions. All subjects were instructed to use the forearm band (Epi Forsa 4061, Rehband, Sweden); Device: Forearm band All subjects were instructed to use the forearm band during all daily activities. Other Name: Epi Forsa 4061, Rehband, Sweden; Device: Forearm band All patients were instructed to use a forearm band during all daily activities. Other Name: Epi Forsa 4061, Rehband, Sweden
Study Arms	Experimental: Eccentric training Interventions: Other: Eccentric training Device: Forearm band; Placebo Comparator: Forearm band Intervention: Device: Forearm band
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 10, 2009)	42
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	May 2005
Actual Primary Completion Date	May 2005 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Positive diagnostic criteria according to Haker (1991): A history of pain around the lateral epicondyle for at least one month.; Pain at palpation of the lateral epicondyle of humerus and positive results in two of the following three pain provocation tests: Middle finger test, resisted extension of the wrist, and Vigorimeter test. Each of these tests is described in detail by Haker (1991) Exclusion Criteria: Subjects with rheumatoid arthritis; Fibromyalgia; Previous surgery in the elbow region; Neck dysfunction suggesting possible cervical rhizopathy; Entrapment of n.radialis; Patients with ongoing treatment, or previous treatment less than three months before enrolled to the study.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	Not Provided
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	NCT00975442
Other Study ID Numbers ICMJE	221/00
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Johan Söderberg P.T., Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Huddinge, Sweden
Study Sponsor ICMJE	Karolinska Institutet
Collaborators ICMJE	Rehband Sweden
Investigators ICMJE	Principal Investigator: Johan Söderberg, P.T. Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Huddinge, Sweden
PRS Account	Karolinska Institutet
Verification Date	September 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP