Effectiveness of Percutaneous Electrolysis in Subacute and Early Chronic Medial Gastrocnemius Muscle Injuries

March 3, 2026 updated by: Carlos Vicente Vega, University of Salamanca

Effectiveness of Percutaneous Electrolysis in Subacute and Early Chronic Medial Gastrocnemius Muscle Injuries: A Single-Blinded Randomized Clinical Trial.

OBJECTIVE: Determine the effectiveness of an intervention that consists of the application of percutaneous electrolysis in different doses compared to the application of a simulated intervention in adults who present a muscle tear in the internal gastrocnemius.

MATERIAL AND METHODS: Around fifty adults with muscle tears in the medial gastrocnemius will be included in the following study. The first group will be treated with high-intensity percutaneous electrolysis (3 mA), the second group will be treated with low-intensity percutaneous electrolysis (0.3 mA), and the third group will receive a sham intervention. Myofascial pain, level of kinesiophobia, range of ankle dorsiflexion with full knee extension, and triceps surae muscle fatigue will be evaluated both before and after treatment.

APPLICABILITY OF THE EXPECTED RESULTS: The results of this study are intended to help provide information about the effects of electrolysis on muscle tears, thus improving their management. Likewise, this work can contribute to the knowledge of the use of percutaneous electrolysis since it applies two protocols with different intensity and application time. In this way, it will provide information on the treatment, management and prognosis of muscle injuries addressed through invasive physiotherapy and more specifically, percutaneous electrolysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Before the application of percutaneous electrolysis (or sham procedure), all participants underwent a standardized pre-treatment protocol including massage therapy, joint mobilization, and radiofrequency diathermy. This protocol was applied uniformly across all groups to ensure consistency and replicate routine clinical practice conditions.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Salamanca
      • Salamanca, Salamanca, Spain, 37005
        • Universidad de Salamanca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Muscle injury in the medial gastrocnemius
  • Pain in the area of injury

  • Informed of the purpose, risks and benefits of this study and written consent to participate in the trial.

    • Available for follow-up.

Exclusion criteria:

  • Active rehabilitation for another musculoskeletal pathology.
  • Belenophobia
  • Immunosuppression.
  • Uncontrolled metabolic diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Subjects treated with high-intensity percutaneous electrolysis.
All participants received a standardized pre-treatment protocol consisting of 10 minutes of massage therapy to the triceps surae, 5 minutes of subtalar joint mobilization, and 10 minutes of radiofrequency diathermy (0.5 MHz, capacitive mode) prior to needle insertion.
Procedure: High intensity percutaneous electrolysis
A sterile, disposable stainless steel needle of different lengths depending on the area to be treated will be connected to the EP device; the gauge of these needles will be 0.25 mm. A current of 3 mA will be applied for 3 times with a duration of 3 seconds each. In order to avoid biases, the technique will be performed for 90 seconds as in the low intensity treatment group and in the last 20 seconds the current will be applied with the parameters previously described. Three sessions divided in three consecutive weeks will be applied.
Active Comparator: Subjects treated with low intensity percutaneous electrolysis.
All participants received a standardized pre-treatment protocol consisting of 10 minutes of massage therapy to the triceps surae, 5 minutes of subtalar joint mobilization, and 10 minutes of radiofrequency diathermy (0.5 MHz, capacitive mode) prior to needle insertion.
Procedure: Low intensity Percutaneous Electrolysis
This technique will be performed with the same instrument as the high intensity technique. It differs from the previous treatment group in that the current intensity in this case will be of an amperage of 0.3mA during 90 seconds. In the same way, 3 sessions divided in 21 consecutive days will be applied.
Sham Comparator: Subjects treated with simulated percutaneous electrolysis
All participants received a standardized pre-treatment protocol consisting of 10 minutes of massage therapy to the triceps surae, 5 minutes of subtalar joint mobilization, and 10 minutes of radiofrequency diathermy (0.5 MHz, capacitive mode) prior to needle insertion.
Procedure: Simulated Percutaneous Electrolysis
The needle and PD device will be connected in the same way as for the other treatment groups. The needle will be inserted without reaching the lesion area and the characteristic sound of turning on the PD machine will be made. It will last 90 seconds and at no time the galvanic current will be applied. The same aseptic precautions will be applied, in addition to performing the same final hemostasis guidelines and providing the same post-treatment guidelines as for all the other subjects in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain at rest
Time Frame: From admission to the end of treatment at 28 days
Pain assessment of participants' pain in both upright and contracted positions will be performed using a 10-point Verbal Numerical Pain Scale (0=no pain, 10=maximum pain tolerable). Subjects will be asked to rate numerically the pain at rest and in a maintained position of elevation of both heels, also commonly known as "standing on tiptoe". In the latter position, 10 will be considered if the subjects fail to stand in this position for at least one complete elevation.
From admission to the end of treatment at 28 days
Pain on load
Time Frame: From admission to the end of treatment at 28 days
Pain assessment of participants' pain in both upright and contracted positions will be performed using a 10-point Verbal Numerical Pain Scale (0=no pain, 10=maximum pain tolerable). Subjects will be asked to rate numerically the pain at rest and in a maintained position of elevation of both heels, also commonly known as "standing on tiptoe". In the latter position, 10 will be considered if the subjects fail to stand in this position for at least one complete elevation.
From admission to the end of treatment at 28 days
Level of kinesiophobia
Time Frame: From admission to the end of treatment at 28 days
Recovery from painful injuries is associated with fear of movement or also called kinesiophobia. It could be defined as an irrational or excessive fear of movement for fear of injury or re-injury. That is why a kinesiophobia questionnaire (Annex II) will be provided at the beginning of the study (day I, assessment and first intervention) to all participants to assess kinesiophobia to perform certain movements that may cause pain or worsen previous injuries. It consists of 11 questions with a minimum score of 11 and a maximum score of 44.
From admission to the end of treatment at 28 days
Ankle dorsiflexion range with the knee in extension.
Time Frame: From admission to the end of treatment at 28 days
The evaluation of this variable will be carried out by measuring the angle extracted from the dorsiflexion of the ankle with a knee extension. This stretch is commonly performed in sports practice so patients are generally already familiar with it. The stretches will be performed with the participants barefoot. Likewise, the participants will be instructed on the positioning of the test. The leg to be evaluated will be placed in such a way that the foot is placed in the midline of an area marked on the floor, and the foot of the healthy leg will be placed forward at the distance of one step. The end point of the gastrocnemius stretch will be defined as the point at which the participants feel discomfort without lifting the heel and without pelvic rotation.
From admission to the end of treatment at 28 days
Muscle fatigue
Time Frame: From admission to the end of treatment at 28 days
Fatigue in this muscle group will be assessed by performing a heel-raise test at the beginning and end of the trial for all participants who have completed it. The test consists of placing the patient on one leg and, using a metronome at a speed of 40 beats per minute (Garmin Fénix 5/5S), asking them to raise their heels. If they are unable to raise their heels for 3 consecutive beats, fatigue will be considered. Light support on a wall is allowed to maintain the patient's balance.
From admission to the end of treatment at 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Salamanca

Investigators

  • Study Director: Fausto Barbero-Iglesias, Doctor, University of Salamanca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2024

Primary Completion (Actual)

March 27, 2025

Study Completion (Actual)

June 12, 2025

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

December 3, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI 2023 08 1418 - TD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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