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 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT05301959
Eligibility Criteria:
Inclusion Criteria:
* Presence of symptoms in one or both Achilles tendons with a minimum duration of two months. In case the symptoms are bilateral, the intervention or placebo will only be administered and its results evaluated- in the limb with greater symptomatology. If it is not possible to differentiate which one presents greater pain, the right Achilles tendon will be chosen.
* Spontaneous pain of at least three points measured by a visual analog scale (VAS), reproducible by palpation between 2 and 6 cm above the insertion of the Achilles tendon in the calcaneal bone.
* Evidence of tendinopathy by MRI.
* Presence of post-static dyskinesia.
* Willingness to not perform additional treatments (such as footwear modifications, physical therapy, orthotics, injections, or surgery) for Achilles tendon pain during the conduct of the trial.
* Willingness to attempt to discontinue self-administration of medications (NSAIDs) for pain relief Achilles tendon(s) pain for at least 14 days prior to baseline assessment and during the course of the trial.
Exclusion Criteria:
* Presence or suspicion of pregnancy.
* Previous surgical intervention on the AT in the symptomatic leg(s)
* Total or partial rupture in the symptomatic AT
* Chronic ankle instability, in the foot with symptomatic tendon(s).
* Pathologies that can derive in pain in the region of the AT without being proper of the picture. (e.g.: osteoarthritis, impingement syndromes).
* Presence of arthritis or any metabolic or endocrine disorder (type 1 or 2 diabetes).
* Psychological disorders.
* Oncologic history.
* Treatment with quinolones or fluoroquinolones during the last two years.
* Treatment with statins for the control of hypercholesterolemia for more than two months
* Treatments within or at the periphery of the Achilles tendon, with anesthetics, corticosteroids or any other pharmacological agent during the last three months.
* Needle phobia
* Allergy to metal
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05301959
Study Brief:
Protocol Section:
NCT05301959