Status:
COMPLETED
Prolotherapy for the Treatment of Chronic Lateral Epicondylitis
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Lateral Epicondylitis
Tennis Elbow
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
Lateral epicondylitis (LE), or tennis elbow, is a common and often disabling condition affecting young and middle-aged adults-most commonly manual workers and recreational athletes. It results in sign...
Detailed Description
Same
Eligibility Criteria
Inclusion
- Ages 18-65, as younger individuals are more likely to have other developmental conditions and older individuals are more likely to have a significant arthritic component to their elbow pain;
- Ability to speak, read, and write English;
- Unilateral or bilateral lateral elbow pain associated with findings on exam consistent with LE and absence of other conditions that can mimic LE such as radial tunnel syndrome.
- Functional impairment, due to the diagnosis of LE, with a Nirschl Pain Phase Scale (NPPS) rating of Phase 4 or higher.
Exclusion
- Other conditions that result in significant impairment in upper extremity function such as fibromyalgia, rotator cuff tendonitis, cervical radiculopathy, or carpal tunnel syndrome;
- Prior surgery of the involved elbow;
- Known allergy to lidocaine or dextrose;
- Presence of an autoimmune condition such as rheumatoid arthritis, given that a possible immune mechanism is hypothesized for PrT.
- Presence of known immune dysfunction, such as with HIV/AIDS, as it might raise the risk for development of infection from injections;
- Ongoing treatment with systemic corticosteroids or immunosuppressant medications, as they may block a potential immune mechanism of the PrT and increase the risk for infection;
- Active diagnosis of malignancy anywhere in the body, given potential of any concurrent immune dysfunction to impact on the response to PrT;
- Treatment with any anticoagulant medication beyond 1 aspirin per day, given the potential to increase bleeding or bruising associated with injections;
- Presence of a coagulopathy, given the potential to increase bleeding or bruising associated with injections;
- Pregnancy-as there is no research documenting safety of PrT during pregnancy;
- Medical necessity for taking ongoing nonsteroidal anti-inflammatory medication, beyond 1 aspirin per day for cardiac prevention, as this may diminish the effect of PrT;
- Corticosteroid injection within the 6 weeks prior to entry into the study, as this may diminish the effect of the PrT.
- Prior treatment with PrT for any condition, as this may impact on blinding.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00674622
Start Date
September 1 2007
End Date
October 1 2011
Last Update
May 16 2016
Active Locations (1)
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1
Center for Integrative Medicine at UPMC Shadyside
Pittsburgh, Pennsylvania, United States, 15232