CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 67 enrolled
Drug / intervention
Prolotherapy +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00674622
NCT00674622Phase 3Completed

Prolotherapy for the Treatment of Chronic Lateral Epicondylitis

University of Pittsburgh·interventional·Posted May 8, 2008·Updated May 16, 2016

In Brief

A Phase 3 clinical trial evaluating Prolotherapy and Placebo for Lateral Epicondylitis and Tennis Elbow. Completed, enrolled 67 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 8, 2008
Enrollment StartSep 1, 2007
Primary CompletionOct 1, 2010
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 18.2 years ago

Interventions

Prolotherapydrug

Injection of 15% dextrose with lidocaine at the lateral epicondyle

Placeboprocedure

Saline/lidocaine