Efficacy of Percutaneous Electrolysis in the Treatment of Achilles Tendinopathy

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

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.

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
    Argentina

    Active - Recruiting

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