Prolotherapy for the Treatment of Chronic Lateral Epicondylitis

NCT ID: NCT00674622

Last Updated: 2016-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2011-10-31

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 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.

Detailed Description

Same

Conditions

Lateral Epicondylitis; Tennis Elbow

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 1-Prolotherapy

Deep injection with 15% dextrose in lidocaine

Group Type: EXPERIMENTAL

Prolotherapy

Intervention Type: DRUG

Injection of 15% dextrose with lidocaine at the lateral epicondyle

Group 2-Deep Saline/Lidocaine

Deep injection with saline/lidocaine

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: PROCEDURE

Saline/lidocaine

Group 3-Superficial Saline/lidocaine

Superficial injection with saline/lidocaine

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: PROCEDURE

Saline/lidocaine

Interventions

Prolotherapy

Injection of 15% dextrose with lidocaine at the lateral epicondyle

Intervention Type: DRUG

Placebo

Saline/lidocaine

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Ronald M. Glick

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ronald M Glick, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Center for Integrative Medicine at UPMC Shadyside

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

1R21AT003969-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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1R21AT003969-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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