Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Pittsburgh
With
National Center for Complementary and Integrative Health (NCCIH)
Same
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Prolotherapy for the Treatment of Chronic Lateral Epicondylitis
