Efficacy of Percutaneous Electrolysis in the Treatment of Achilles Tendinopathy

NCT05301959 | Recruiting DMC

• 1 other identifier: 5694
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Achilles Tendinopathy

Keywords

tendinopathy; physiotherapy; percutaneous electrolysis

Outcome Measures

Primary Outcomes (15)

• Victorian Institute of Sport Assessment - Achilles - Baseline

  patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).

  Baseline

• Victorian Institute of Sport Assessment - Achilles - Week 1

  patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).

  one week at study entry

• Victorian Institute of Sport Assessment - Achilles - Week 2

  patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).

  two week at study entry

• Victorian Institute of Sport Assessment - Achilles - Week 3

  patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).

  three week at study entry

• Victorian Institute of Sport Assessment - Achilles - Week 4

  patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).

  four week at study entry

• Victorian Institute of Sport Assessment - Achilles - Week 5

  patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).

  five week at study entry

• Victorian Institute of Sport Assessment - Achilles - Week 6

  patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).

  six week at study entry

• Victorian Institute of Sport Assessment - Achilles - Week 7

  patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).

  seven week at study entry

• Victorian Institute of Sport Assessment - Achilles - Week 8

  patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).

  eight week at study entry

• Victorian Institute of Sport Assessment - Achilles - Week 9

  patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).

  nine week at study entry

• Victorian Institute of Sport Assessment - Achilles - Week 10

  patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).

  ten week at study entry

• Victorian Institute of Sport Assessment - Achilles - Week 11

  patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).

  eleven week at study entry

• Victorian Institute of Sport Assessment - Achilles - Week 12

  patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).

  twelve week at study entry

• Victorian Institute of Sport Assessment - Achilles - Week 26

  patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).

  twenty-six week at study entry

• Victorian Institute of Sport Assessment - Achilles - Week 52

  patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).

  fifty-two week at study entry

Secondary Outcomes (42)

• visual analog scale - Baseline

  Baseline

• visual analog scale - Week 1

  one week at study entry

• visual analog scale - Week 2

  Two week at study entry

• visual analog scale - Week 3

  three week at study entry

• visual analog scale - Week 4

  four week at study entry

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Device: low intensity percutaneous musculoskeletal electrolysis; Other: Silbernagel protocol

Simulated group.

SHAM COMPARATOR

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

Device: Sham application; Other: Silbernagel protocol

Interventions

low intensity percutaneous musculoskeletal electrolysis DEVICE

An acupuncture needle (0.30mm X 25mm) will be introduced into the device's strut. With the equipment on and with a base intensity of 120µA, the acupuncture needle is introduced in a proximal-distal and postero-anterior direction, in the area of the Achilles tendon body. The position of the needle will be checked with ultrasound and once the point to be treated is reached, the working intensity will be increased up to 600 µA. The emission will be maintained until the participant reports a pain of 60/100 in VAS. At that moment, the emission will be paused completely until the participant reports a sensation of at least 20/100 in VAS. After this period the emission will be continued at 600 µA. This cycle will continue until the emission lasts for more than 120 sec, continuously. At this point, the needle will be repositioned to repeat the emission protocol a maximum of 3 times in total.

Also known as: percutaneous microelectrolysis

Experimental group

Sham application DEVICE

A modification will be made in a second equipment, closing the circuit with a 10kΩ resistor inside the equipment, in the output strand chip. Allowing the simulation of emission without emitting current to the participant and without being able to appreciate any type of alteration in the handling of the equipment, by the operators. Therefore, the same steps will be followed as in the experimental group.

Simulated group.

Silbernagel protocol OTHER

The Silbernagel et al. protocol comprises several heel raising exercises with concentric and eccentric movements, performed on two legs and one leg. It is composed of 3 sets of 15 repetitions and that during the exercises allows pain to be present, but not being disabling. The exercises will be performed only once a day. The progression will be made by changing from standing exercises to monopodal support, moving from concentric-eccentric to purely eccentric loading, adding weight in a backpack (in steps of 5 kg when pain does not exceed 5 in the pain monitoring model) and finally using fast rebound exercises and plyometric exercises.

Also known as: Silbernagel et al. Achilles tendinopathy protocol

Experimental group; Simulated group.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maimonides University: lead

Study Sites (1)

Maimonides University

Buenos Aires, Buenos Aires F.D., 1405, Argentina

RECRUITING

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Study Officials

• Santiago M d'Almeida, PT SCS

  Maimonides University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Santiago M d'Almeida, PT SCS

CONTACT

01140573099; dalmeida.santiago@maimonides.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2022
• First Posted: March 31, 2022
• Study Start: July 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

AR (1)