Evaluation of the Efficacy of Adding Low-intensity Percutaneous Musculoskeletal Electrolysis to the Conservative Treatment of Noninsertional Achilles Tendinopathy: a Randomized Controlled Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Argentina
Maimonides University
RECRUITING
Buenos Aires
Contact Information
Primary
Santiago M d'Almeida, PT SCS
dalmeida.santiago@maimonides.edu
01140573099
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 102
Treatments
Experimental: Experimental group
A single weekly intervention of low intensity galvanic currents will be applied in an ultrasound-guided manner.
Sham_comparator: Simulated group.
The application of a single weekly intervention of low intensity galvanic currents will be simulated in an echogenic way, with the equipment turned off.
Related Therapeutic Areas
Sponsors
Leads: Maimonides University

This content was sourced from clinicaltrials.gov