Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT01476605
Eligibility Criteria:
Inclusion Criteria:
1. age 18-65 years
2. diagnosis of CLE, confirmed by the PI using clinical symptoms and exam findings of tenderness over the lateral epicondyle and/or extensor tendon, and pain on 2 extensor muscle provocation tests
3. self-reported CLE-related pain for at least 6 months
4. self-reported failure of at least 2 of the 3 most common treatments for CLE (a course of NSAIDS, physical therapy or corticosteroid injections).
Exclusion Criteria:
1. current bilateral CLE
2. a corticosteroid injection in the prior 3 months or prior PrT or PRP for CLE
3. current carpal tunnel syndrome, other elbow pathology, or acute trauma of the CLE-affected upper extremity
4. self-reported history of bleeding disorders, other hematologic conditions, inflammatory arthritis, systemic nervous system disease, upper extremity surgeries or neuropathy
5. current use of opioids for pain
6. anticoagulation or immunosuppressive therapy in the prior month
7. intent to use NSAIDs or steroids
8. known allergy to dextrose, acetaminophen or lidocaine
9. MRI contraindications: non-compatible metal in the CLE-affected upper extremity or severe claustrophobia
10. unresolved litigation
11. self-reported pregnancy. Pregnant women are excluded from the study because pregnancy changes the characteristics of connective tissue including ligaments and tendons associated with CLE and, so, is an unacceptable confounder in this pilot level study. There is no report however, about dextrose, morrhuate sodium or PrT being harmful to pregnant women. Therefore we will not draw confirmatory labs to ensure that women of childbearing age are not pregnant. Rather we will accept self-report on pregnancy status at the time of consent. If a woman becomes pregnant during the study she will be dropped from the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01476605
Study Brief:
Protocol Section:
NCT01476605