RecruitingNot Applicable

Efficacy of Percutaneous Electrolysis in the Treatment of Achilles Tendinopathy

Argentina102 participantsStarted 2023-07-01

Plain-language summary

Achilles tendinopathy (AT) is one of the most reported myotendinous pathologies due to overuse in the literature. In the general adult population, its incidence is 2.35 cases per 1,000 patients, with no difference between men and women. The international literature reports that up to 29% of patients fail with conservative treatment. Within physiotherapy, new alternatives for the treatment of tendinopathies arise, applying electric currents percutaneously, which from a mechanical effect associated to the use of a needle and an electric effect by the use of galvanic currents, generate a local inflammatory response; activation of the central nervous system and analgesia. The aim of the research is to evaluate the efficacy of adding low intensity percutaneous electrolysis to the treatment with a high load eccentric exercise program based on the protocol of Silbernagel et al. in adults with Achilles tendinopathy to improve its functionality. A randomized, double-blind, blinded, evaluator-blinded, controlled clinical trial will be conducted in parallel groups (experimental treatment vs. sham treatment), with a follow-up at 26 and 52 weeks after the first intervention. Non-probability and intentional sampling will be performed.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 en…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Victorian Institute of Sport Assessment - Achilles - Baseline

Timeframe: Baseline

Victorian Institute of Sport Assessment - Achilles - Week 1

Timeframe: one week at study entry

Victorian Institute of Sport Assessment - Achilles - Week 2

Timeframe: two week at study entry

Victorian Institute of Sport Assessment - Achilles - Week 3

Timeframe: three week at study entry

Victorian Institute of Sport Assessment - Achilles - Week 4

Timeframe: four week at study entry

Victorian Institute of Sport Assessment - Achilles - Week 5

Timeframe: five week at study entry

Victorian Institute of Sport Assessment - Achilles - Week 6

Timeframe: six week at study entry

Trial details

NCT IDNCT05301959

SponsorMaimonides University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Santiago M d'Almeida, PT SCS

01140573099 dalmeida.santiago@maimonides.edu

View on ClinicalTrials.gov More Achilles Tendinopathy trials