- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00674622
Prolotherapy for the Treatment of Chronic Lateral Epicondylitis
May 13, 2016 updated by: Ronald M. Glick, University of Pittsburgh
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Same
Study Type
Interventional
Enrollment (Actual)
67
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15232
- Center for Integrative Medicine at UPMC Shadyside
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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;
- Ability to speak, read, and write English;
- 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.
- Functional impairment, due to the diagnosis of LE, with a Nirschl Pain Phase Scale (NPPS) rating of Phase 4 or higher.
Exclusion Criteria:
- Other conditions that result in significant impairment in upper extremity function such as fibromyalgia, rotator cuff tendonitis, cervical radiculopathy, or carpal tunnel syndrome;
- Prior surgery of the involved elbow;
- Known allergy to lidocaine or dextrose;
- Presence of an autoimmune condition such as rheumatoid arthritis, given that a possible immune mechanism is hypothesized for PrT.
- Presence of known immune dysfunction, such as with HIV/AIDS, as it might raise the risk for development of infection from injections;
- 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;
- Active diagnosis of malignancy anywhere in the body, given potential of any concurrent immune dysfunction to impact on the response to PrT;
- Treatment with any anticoagulant medication beyond 1 aspirin per day, given the potential to increase bleeding or bruising associated with injections;
- Presence of a coagulopathy, given the potential to increase bleeding or bruising associated with injections;
- Pregnancy-as there is no research documenting safety of PrT during pregnancy;
- 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;
- Corticosteroid injection within the 6 weeks prior to entry into the study, as this may diminish the effect of the PrT.
- Prior treatment with PrT for any condition, as this may impact on blinding.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1-Prolotherapy
Deep injection with 15% dextrose in lidocaine
|
Injection of 15% dextrose with lidocaine at the lateral epicondyle
|
Placebo Comparator: Group 2-Deep Saline/Lidocaine
Deep injection with saline/lidocaine
|
Saline/lidocaine
|
Placebo Comparator: Group 3-Superficial Saline/lidocaine
Superficial injection with saline/lidocaine
|
Saline/lidocaine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 weeks and 12 weeks post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 weeks and 12 weeks post-intervention
|
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.
|
6 weeks and 12 weeks post-intervention
|
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.
|
6 and 12 weeks post-intervention
|
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.
|
6 and 12 weeks post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
May 6, 2008
First Submitted That Met QC Criteria
May 7, 2008
First Posted (Estimate)
May 8, 2008
Study Record Updates
Last Update Posted (Estimate)
May 16, 2016
Last Update Submitted That Met QC Criteria
May 13, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R21AT003969-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Presented at conference.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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