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:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
NCT ID:
NCT01911650
Eligibility Criteria:
Inclusion Criteria:
1. age 18-65 years, inclusive
2. diagnosis of moderate to severe AT, confirmed by Dr. Wilson using clinical symptoms and exam findings consistent with chronic AT (\>6 month duration) - which includes pain while palpating the intratendinous swelling part of the Achilles tendon and relief of pain when tendon placed under tension - and pre-procedure US
3. self-reported AT-related pain for at least 6 months and VAS (Visual Analog Scale) pain \>5 (0-10 scale)
4. self-reported failure of eccentric exercise protocol (at least 75% completion)
5. self-reported failure of at least 2 of the 3 most common treatments for AT (NSAIDS, rest/ice or taping)
6. patient considered surgery but decided to wait and/or refused surgery -
Exclusion Criteria:
1. bilateral AT
2. insertional AT
3. local steroid injection within 6 weeks or physical therapy within 4 weeks
4. inability to comply with follow-up criteria
5. history of surgery on the Achilles tendon or systemic diseases (general inflammatory diseases such as rheumatologic disorders and diabetes)
6. daily use of opioids for pain
7. anticoagulation or immunosuppressive therapy
8. intent to use NSAIDs or steroids
9. self-reported pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01911650
Study Brief:
Protocol Section:
NCT01911650