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Prolotherapy for the Treatment of Chronic Lateral Epicondylitis

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ClinicalTrials.gov Identifier: NCT00674622
Recruitment Status : Completed
First Posted : May 8, 2008
Results First Posted : May 16, 2016
Last Update Posted : May 16, 2016
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Ronald M. Glick, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE May 6, 2008
First Posted Date  ICMJE May 8, 2008
Results First Submitted Date  ICMJE January 8, 2016
Results First Posted Date  ICMJE May 16, 2016
Last Update Posted Date May 16, 2016
Study Start Date  ICMJE September 2007
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2016)
McGill Pain Questionnaire [ Time Frame: 6 weeks and 12 weeks post intervention ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2008)
McGill Pain Questionnaire [ Time Frame: 6 weeks and 12 weeks post intervention ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2016)
  • QuickDASH [ Time Frame: 6 weeks and 12 weeks post-intervention ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2008)
  • Upper Extremity Functioning on the QuickDASH [ Time Frame: 6 weeks and 12 weeks post-intervention ]
  • Physical measures including grip strength and pain threshold on dolorimetry. [ Time Frame: 6 weeks and 12 weeks post-intervention ]
  • Nirschl Pain Phase Scale [ Time Frame: 6 weeks post-intervention ]
  • Adverse event form [ Time Frame: Every 3 weeks during intervention ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prolotherapy for the Treatment of Chronic Lateral Epicondylitis
Official Title  ICMJE Prolotherapy for the Treatment of Chronic Lateral Epicondylitis
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Lateral Epicondylitis
  • Tennis Elbow
Intervention  ICMJE
  • Drug: Prolotherapy
    Injection of 15% dextrose with lidocaine at the lateral epicondyle
  • Procedure: Placebo
    Saline/lidocaine
Study Arms  ICMJE
  • Experimental: Group 1-Prolotherapy
    Deep injection with 15% dextrose in lidocaine
    Intervention: Drug: Prolotherapy
  • Placebo Comparator: Group 2-Deep Saline/Lidocaine
    Deep injection with saline/lidocaine
    Intervention: Procedure: Placebo
  • Placebo Comparator: Group 3-Superficial Saline/lidocaine
    Superficial injection with saline/lidocaine
    Intervention: Procedure: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2012)
67
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2008)
60
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00674622
Other Study ID Numbers  ICMJE 1R21AT003969-01A1( U.S. NIH Grant/Contract )
1R21AT003969-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Presented at conference.
Responsible Party Ronald M. Glick, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Ronald M Glick, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP