Efficacy of Percutaneous Electrolysis in the Treatment of Achilles Tendinopathy

Maimonides University

Status: Enrolling

Conditions: Achilles Tendinopathy

Treatments: Device: Sham application; Device: low intensity percutaneous musculoskeletal electrolysis; Other: Silbernagel protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT05301959

5694

Details and patient eligibility

About

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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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102 participants in 2 patient groups

Experimental group

Experimental group

Description:

A single weekly intervention of low intensity galvanic currents will be applied in an ultrasound-guided manner.

Treatment:

Other: Silbernagel protocol

Device: low intensity percutaneous musculoskeletal electrolysis

Simulated group.

Sham Comparator group

Description:

The application of a single weekly intervention of low intensity galvanic currents will be simulated in an echogenic way, with the equipment turned off.

Treatment:

Other: Silbernagel protocol

Device: Sham application