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Prolotherapy for the Treatment of Chronic Lateral Epicondylitis

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
Ronald M. Glick, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00674622
First received: May 6, 2008
Last updated: June 14, 2012
Last verified: June 2012
History of Changes
  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
 Drug: Prolotherapy
Procedure: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prolotherapy for the Treatment of Chronic Lateral Epicondylitis

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 67
Study Start Date: September 2007
Study Completion Date: October 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Procedure: Placebo
Saline/lidocaine
Placebo Comparator: 2 Procedure: Placebo
Saline/lidocaine
Experimental: 3 Drug: 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:

  1. 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;
  2. Ability to speak, read, and write English;
  3. 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.
  4. Functional impairment, due to the diagnosis of LE, with a Nirschl Pain Phase Scale (NPPS) rating of Phase 4 or higher.

Exclusion Criteria:

  1. Other conditions that result in significant impairment in upper extremity function such as fibromyalgia, rotator cuff tendonitis, cervical radiculopathy, or carpal tunnel syndrome;
  2. Prior surgery of the involved elbow;
  3. Known allergy to lidocaine or dextrose;
  4. Presence of an autoimmune condition such as rheumatoid arthritis, given that a possible immune mechanism is hypothesized for PrT.
  5. Presence of known immune dysfunction, such as with HIV/AIDS, as it might raise the risk for development of infection from injections;
  6. 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;
  7. Active diagnosis of malignancy anywhere in the body, given potential of any concurrent immune dysfunction to impact on the response to PrT;
  8. Treatment with any anticoagulant medication beyond 1 aspirin per day, given the potential to increase bleeding or bruising associated with injections;
  9. Presence of a coagulopathy, given the potential to increase bleeding or bruising associated with injections;
  10. Pregnancy—as there is no research documenting safety of PrT during pregnancy;
  11. 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;
  12. Corticosteroid injection within the 6 weeks prior to entry into the study, as this may diminish the effect of the PrT.
  13. 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

Locations
United States, Pennsylvania
Center for Integrative Medicine at UPMC Shadyside
Pittsburgh, Pennsylvania, United States, 15232
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

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

No publications provided

Responsible Party: Ronald M. Glick, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00674622     History of Changes
Other Study ID Numbers: 1R21AT003969-01A1
Study First Received: May 6, 2008
Last Updated: June 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Lateral epidondylitis
Tennis elbow
Prolotherapy

Additional relevant MeSH terms:
Tennis Elbow
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013