Status:
COMPLETED
Efficacy of Injection Therapy for Lateral Epicondylosis
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Tennis Elbow
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
While evidence does not identify any conventional therapy as definitive for chronic lateral epicondylosis (CLE, tennis elbow), basic science and limited pilot level trials support rigorous assessment ...
Detailed Description
CLE is a prevalent, disabling condition with significant individual and societal costs. The incidence of CLE is increasing. CLE is often refractory to care. There is limited scientific evidence to sup...
Eligibility Criteria
Inclusion
- age 18-65 years
- diagnosis of CLE, confirmed by the PI using clinical symptoms and exam findings of tenderness over the lateral epicondyle and/or extensor tendon, and pain on 2 extensor muscle provocation tests
- self-reported CLE-related pain for at least 6 months
- self-reported failure of at least 2 of the 3 most common treatments for CLE (a course of NSAIDS, physical therapy or corticosteroid injections).
Exclusion
- current bilateral CLE
- a corticosteroid injection in the prior 3 months or prior PrT or PRP for CLE
- current carpal tunnel syndrome, other elbow pathology, or acute trauma of the CLE-affected upper extremity
- self-reported history of bleeding disorders, other hematologic conditions, inflammatory arthritis, systemic nervous system disease, upper extremity surgeries or neuropathy
- current use of opioids for pain
- anticoagulation or immunosuppressive therapy in the prior month
- intent to use NSAIDs or steroids
- known allergy to dextrose, acetaminophen or lidocaine
- MRI contraindications: non-compatible metal in the CLE-affected upper extremity or severe claustrophobia
- unresolved litigation
- self-reported pregnancy. Pregnant women are excluded from the study because pregnancy changes the characteristics of connective tissue including ligaments and tendons associated with CLE and, so, is an unacceptable confounder in this pilot level study. There is no report however, about dextrose, morrhuate sodium or PrT being harmful to pregnant women. Therefore we will not draw confirmatory labs to ensure that women of childbearing age are not pregnant. Rather we will accept self-report on pregnancy status at the time of consent. If a woman becomes pregnant during the study she will be dropped from the study.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01476605
Start Date
June 1 2009
End Date
December 1 2015
Last Update
February 18 2019
Active Locations (2)
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1
Northeast Family Medical Center
Madison, Wisconsin, United States, 53704
2
University of Wisconsin General Clinical Research Center
Madison, Wisconsin, United States, 53792