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 @ 1:40 PM
Ignite Modification Date:
2025-12-24 @ 1:40 PM
NCT ID:
NCT06736795
Eligibility Criteria:
Inclusion Criteria:
* Pain localized to the Achilles tendon (insertion or midportion)
* AT pain greater than or equal to 3/10 with tendon-loading exercise
Exclusion Criteria:
* Younger than 18 years of age or older than 60 years of age
* BMI \> 45 kg/m2
* Pain primarily due to a differential diagnosis, including paratendonitis, bursitis (retrocalcaneal or subcutaneous), posterior ankle impingement or os trigonum, irritation or neuropathy of the sural nerve, plantaris tendon involvement)
* Presence of a partial Achilles tendon tear or rupture on imaging or a history of Achilles tendon rupture that was verified by surgical or conservative management
* Attended physical therapy for AT in the past 3 months
* History of steroid injection to lower extremity tendons/fascia, ESWT or any injection to the Achilles tendon region in the past 3 months
* History of taking fluoroquinolones in the past 6 months
* History of surgery or invasive procedure for AT on side enrolling for treatment
* Diagnosed systemic conditions affecting the foot and ankle (e.g., rheumatoid arthritis, ankylosing spondylitis), endocrine disorder with complications (e.g., uncontrolled Type I or II diabetes, diabetic peripheral neuropathy), connective tissue disorder (e.g., Marfan's syndrome, Ehlers Danlos), or pregnancy
* At high risk for falls (four step square test \>15 seconds)
* Refusal of randomization or unable or uninterested in completing virtual visits with a webcam or smart phone or completing quizzes and surveys
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06736795
Study Brief:
Protocol Section:
NCT06736795