Expired Study
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Pittsburgh, Pennsylvania 15232


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.


Study summary:

Same


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.


Study is Available At:


Original ID:

1R21AT003969-01A1


NCT ID:

NCT00674622


Secondary ID:

1R21AT003969-01A1


Study Acronym:


Brief Title:

Prolotherapy for the Treatment of Chronic Lateral Epicondylitis


Official Title:

Prolotherapy for the Treatment of Chronic Lateral Epicondylitis


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pittsburgh


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

67


Enrollment Type:

Actual


Overall Contact Information

Official Name:Ronald M Glick, MD
Principal Investigator
University of Pittsburgh

Study Dates

Start Date:September 2007
Completion Date:October 2011
Completion Type:Actual
Primary Completion Date:October 2010
Primary Completion Type:Actual
Verification Date:May 2016
Last Changed Date:May 13, 2016
First Received Date:May 6, 2008
First Results Date:January 8, 2016

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Pain Threshold on Dolorimetry
Time Frame:6 and 12 weeks post-intervention
Safety Issues:True
Description: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.
Outcome Type:Secondary Outcome
Measure:Nirschl Pain Phase Scale
Time Frame:6 and 12 weeks post-intervention
Safety Issues:False
Description: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 ra
Outcome Type:Secondary Outcome
Measure:Grip Strength
Time Frame:6 weeks and 12 weeks post-intervention
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:QuickDASH
Time Frame:6 weeks and 12 weeks post-intervention
Safety Issues:False
Description: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 collaborat
Outcome Type:Primary Outcome
Measure:McGill Pain Questionnaire
Time Frame:6 weeks and 12 weeks post intervention
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Drug
Name:Prolotherapy
Description:Injection of 15% dextrose with lidocaine at the lateral epicondyle
Arm Name:Group 1-Prolotherapy
Intervention Type:Procedure
Name:Placebo
Description:Saline/lidocaine
Arm Name:Group 2-Deep Saline/Lidocaine

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Group 3-Superficial Saline/lidocaine
Description:Superficial injection with saline/lidocaine
Study Arm Type:Placebo Comparator
Arm Name:Group 2-Deep Saline/Lidocaine
Description:Deep injection with saline/lidocaine
Study Arm Type:Experimental
Arm Name:Group 1-Prolotherapy
Description:Deep injection with 15% dextrose in lidocaine

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Pittsburgh
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Center for Complementary and Integrative Health (NCCIH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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