Prolotherapy for the Treatment of Chronic Lateral Epicondylitis
Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
Participant gender:
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 significant pain and disability, limiting work productivity and an
individual's ability to participate in and enjoy recreational activities. Like many other
chronic musculoskeletal conditions LE often shows an incomplete response to acute treatments,
leading to chronic pain and disability. Prolotherapy (PrT) involves the injection of an
irritant or proliferant solution into tendons, ligaments, and joints to treat chronic
musculoskeletal pain. We will be conducting a 3-group randomized, blinded trial to determine
the safety and efficacy of PrT injections in the treatment of chronic LE. Additionally, we
will seek to determine to what extent any beneficial effect of PrT is derived from deep
needle placement vs. a specific effect of the injectate. The specific aims for this study
are: 1) to determine if PrT is a safe, well-tolerated, and effective treatment for
individuals with chronic LE; and 2) to determine whether the deep needle placement alone is
responsible for the therapeutic effect, independent of injectate. In order to accomplish
these aims, we will measure indicators of pain and disability using self-rating scales,
questionnaires and physical measures. Subjects will be stratified prior to randomization on
two factors: 1) unilateral vs. bilateral LE; and 2) treatment with steroids within the prior
6 months. If effective, subjects receiving PrT will show greater reduction of pain and
functional impairment compared with the other two groups. This research will guide future
studies on prolotherapy by determining what may be the best control condition. Additionally,
further studies may explore the mechanism responsible for any beneficial effect.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of Pittsburgh
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)