Last updated: July 29, 2023
Sponsor: Maimonides University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Tendon Injuries
Sprains
Treatment
low intensity percutaneous musculoskeletal electrolysis
Silbernagel protocol
Sham application
Clinical Study ID
NCT05301959
5694
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Presence of symptoms in one or both Achilles tendons with a minimum duration of twomonths. In case the symptoms are bilateral, the intervention or placebo will only beadministered and its results evaluated- in the limb with greater symptomatology. If itis not possible to differentiate which one presents greater pain, the right Achillestendon 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 Achillestendon 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 duringthe conduct of the trial.
- Willingness to attempt to discontinue self-administration of medications (NSAIDs) forpain relief Achilles tendon(s) pain for at least 14 days prior to baseline assessmentand during the course of the trial.
Exclusion
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 ofthe 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 twomonths
- 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
Study Design
Total Participants: 102
Treatment Group(s): 3
Primary Treatment: low intensity percutaneous musculoskeletal electrolysis
Phase:
Study Start date:
July 01, 2023
Estimated Completion Date:
December 31, 2025
Connect with a study center
Maimonides University
Ciudad Autonoma de Buenos Aires, Caba 1405
ArgentinaActive - Recruiting
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