Prolotherapy for the Treatment of Chronic Lateral Epicondylitis - Full Text View

Sponsors and Collaborators:	University of Pittsburgh National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00674622

Purpose

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.

Condition	Intervention	Phase
Lateral Epicondylitis Tennis Elbow	Procedure: Prolotherapy Procedure: Placebo	Phase II Phase III

MedlinePlus related topics: Elbow Injuries and Disorders

Drug Information available for: Dextrose Lidocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Prolotherapy for the Treatment of Chronic Lateral Epicondylitis

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

McGill Pain Questionnaire [ Time Frame: 6 weeks and 12 weeks post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Upper Extremity Functioning on the QuickDASH [ Time Frame: 6 weeks and 12 weeks post-intervention ] [ Designated as safety issue: No ]
Physical measures including grip strength and pain threshold on dolorimetry. [ Time Frame: 6 weeks and 12 weeks post-intervention ] [ Designated as safety issue: No ]
Nirschl Pain Phase Scale [ Time Frame: 6 weeks post-intervention ] [ Designated as safety issue: No ]
Adverse event form [ Time Frame: Every 3 weeks during intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Procedure: Placebo
2: Placebo Comparator	Procedure: Placebo
3: Experimental	Procedure: Prolotherapy Injection of 15% dextrose with lidocaine at the lateral epicondyle

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674622

Contacts

Contact: Mark Shefsiek	412-623-3811	shefsiekmd@upmc.edu
Contact: J. Megan DeBertrand	412-623-6872	debertrandjm@upmc.edu

Locations

United States, Pennsylvania
Center for Integrative Medicine at UPMC Shadyside	Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Principal Investigator: Ronald M Glick, MD
Sub-Investigator: Neal D Ryan, MD
Sub-Investigator: Richard Day, PhD
Sub-Investigator: Michael J Schneider, DC
Sub-Investigator: David A Stone, MD
Sub-Investigator: Megan Cortazzo, MD

Sponsors and Collaborators

University of Pittsburgh

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Ronald M Glick, MD

University of Pittsburgh

More Information

Center for Integrative Medicine at UPMC Shadyside Research page This link exits the ClinicalTrials.gov site

Responsible Party:	University of Pittsbrugh School of Medicine ( Ronald M. Glick, M.D. Assistant Professor of Psychiatry, Physical Medicine and Rehabilation, and Family Medicine )
Study ID Numbers:	1R21AT003969-01A1
Study First Received:	May 6, 2008
Last Updated:	May 7, 2008
ClinicalTrials.gov Identifier:	NCT00674622
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:

Lateral epidondylitis
Tennis elbow
Prolotherapy

Study placed in the following topic categories:

Musculoskeletal Diseases
Tennis Elbow
Lidocaine

Wounds and Injuries
Disorders of Environmental Origin
Arm Injuries

ClinicalTrials.gov processed this record on January 16, 2009