Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Prolotherapy for the Treatment of Chronic Lateral Epicondylitis

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Ronald M. Glick, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00674622
First received: May 6, 2008
Last updated: May 13, 2016
Last verified: May 2016
  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:


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 ]
    This is a pain severity rating. 15 adjectival descriptors of pain are scored on a 0-3 scale for a total score of 0-45 with a high score reflecting greater pain severity.


Secondary Outcome Measures:
  • QuickDASH [ Time Frame: 6 weeks and 12 weeks post-intervention ] [ Designated as safety issue: No ]
    The QuickDASH is an abbreviated form of the rating scale DASH or Disabilities of the Arm, Shoulder, & Hand. This is a self-report rating of function for individuals with problems of the upper extremity. The Institute for Work and Health, in collaboration with the American Academy of Orthopaedic Surgeons developed a self-report questionnaire "Disabilities of the Arm, Shoulder, & Hand". It is seen as a valid and reliable measure of upper extremity functional impairment, is in widespread use in the States and abroad, having been translated into multiple languages and has been used for studies on LE. 11 items are scored on this self-rating instrument on a 1-5 Likert scale with higher score reflecting greater disability. The scores are averaged and then converted to a 100 point scale (0-100), with higher score reflecting greater disability.

  • Grip Strength [ Time Frame: 6 weeks and 12 weeks post-intervention ] [ Designated as safety issue: No ]
    Maximal pain-free grip strength has been used as a physical correlate of disability associated with LE. Grip strength was obtained using a Jamar Dynamometer set in the 2nd position. 3 trials were recorded and the average pain-free grip strength was noted.

  • Nirschl Pain Phase Scale [ Time Frame: 6 and 12 weeks post-intervention ] [ Designated as safety issue: No ]
    The Nirschl Pain Phase Scale (NPPS), which has been used to describe functional impairment related to tendinopathies such as lateral epicondylitis. This scale provides a global rating of impairment associated with sports and musculoskeletal injuries. A rating from 0-7 describes the phase of overuse injuries, with Phase 0 noting "No stiffness or soreness after activity" and Phase 7 corresponding with "Pain that also disrupts sleep consistently. Pain is aching in nature and intensifies with activity". It was used as an indication of severity for entry into the study and as the criterion for treatment response.

  • Pain Threshold on Dolorimetry [ Time Frame: 6 and 12 weeks post-intervention ] [ Designated as safety issue: Yes ]
    Pressure pain threshold (PPT) has been noted to correlate with pain and disability associated with LE. PPT was determined by applying pressure with a digital algometer over the area of maximal tenderness corresponding with the common extensor tendon area. Only 1 determination was obtained as the 1st application of pressure can lower the pain threshold for subsequent testing.


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
Experimental: Group 1-Prolotherapy
Deep injection with 15% dextrose in lidocaine
Drug: Prolotherapy
Injection of 15% dextrose with lidocaine at the lateral epicondyle
Placebo Comparator: Group 2-Deep Saline/Lidocaine
Deep injection with saline/lidocaine
Procedure: Placebo
Saline/lidocaine
Placebo Comparator: Group 3-Superficial Saline/lidocaine
Superficial injection with saline/lidocaine
Procedure: Placebo
Saline/lidocaine

Detailed Description:
Same
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Integrative Health (NCCIH)
Investigators
Principal Investigator: Ronald M Glick, MD University of Pittsburgh
  More Information

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
Results First Received: January 8, 2016
Last Updated: May 13, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Presented at conference.

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

Additional relevant MeSH terms:
Tennis Elbow
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 26, 2016