- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00975442
Effects of Eccentric Training for Patients With Lateral Epicondylalgia
September 10, 2009 updated by: Karolinska Institutet
Effects of Eccentric Training for Patients With Lateral Epicondylalgia - a Randomized Controlled Trial
The purpose of this study is to evaluate eccentric training as an intervention for lateral epicondylalgia (tennis elbow) in a clinical setting.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Stockholm, Sweden, 17177
- Karolinska Institutet
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 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)
All subjects were instructed to use the forearm band during all daily activities.
Other Names:
All patients were instructed to use a forearm band during all daily activities.
Other Names:
|
|
PLACEBO_COMPARATOR: Forearm band
|
All subjects were instructed to use the forearm band during all daily activities.
Other Names:
All patients were instructed to use a forearm band during all daily activities.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
3 wk and 6 wk follow up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
3 wk and 6 wk follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Johan Söderberg, P.T., Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Huddinge, Sweden
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Primary Completion (ACTUAL)
May 1, 2005
Study Completion (ACTUAL)
May 1, 2005
Study Registration Dates
First Submitted
September 10, 2009
First Submitted That Met QC Criteria
September 10, 2009
First Posted (ESTIMATE)
September 11, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
September 11, 2009
Last Update Submitted That Met QC Criteria
September 10, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 221/00
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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