Muscle InjuryNCT06713200

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

A study testing High intensity percutaneous electrolysis, Low intensity Percutaneous Electrolysis and Simulated Percutaneous Electrolysis in people with Muscle Injury and Fibrosis, run by University of Salamanca at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Muscle Injury, Fibrosis
What is being tested?: High intensity percutaneous electrolysis, Low intensity Percutaneous Electrolysis and Simulated Percutaneous Electrolysis
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 75 participants
Where: 1 siteSpain
Study dates: 26 Nov 2024to 12 Jun 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Universidad de Salamanca
Salamanca, Salamanca, 37005

Other trials in Spain

About this study

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

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.

Read the 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.

Conditions: Muscle Injury, Fibrosis
Being tested: High intensity percutaneous electrolysis, Low intensity Percutaneous Electrolysis, Simulated Percutaneous Electrolysis
Keywords: TENNIS LEG, GASTROCNEMIOUS INJURY, FIBROSIS, PERCUTANEOUS ELECTROLYSIS
Medical subject headings: Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High intensity percutaneous electrolysisProcedure or surgery
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.
Low intensity Percutaneous ElectrolysisProcedure or surgery
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.
Simulated Percutaneous ElectrolysisProcedure or surgery
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.

Study groups in NCT06713200
Study group	Role	What they receive
Subjects treated with high-intensity percutaneous electrolysis.	Active comparator	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. Receives: Procedure: High intensity percutaneous electrolysis
Subjects treated with low intensity percutaneous electrolysis.	Active comparator	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. Receives: Procedure: Low intensity Percutaneous Electrolysis
Subjects treated with simulated percutaneous electrolysis	Sham comparator	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. Receives: Procedure: Simulated Percutaneous Electrolysis

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain at rest
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.
Measured: From admission to the end of treatment at 28 days
Pain on load
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.
Measured: From admission to the end of treatment at 28 days
Level of kinesiophobia
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.
Measured: From admission to the end of treatment at 28 days
Ankle dorsiflexion range with the knee in extension.
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.
Measured: From admission to the end of treatment at 28 days
Muscle fatigue
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.
Measured: From admission to the end of treatment at 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Nov 202412 Jun 2025

First posted3 Dec 2024
Study start26 Nov 2024
Primary completion27 Mar 2025
Study completion12 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Muscle InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The study will include pacients randomized into three treatment groups: high-intensity percutaneous electrolysis, low-intensity and a control group with sham treatment.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06713200
Sponsor's protocol ID: PI 2023 08 1418 - TD
Status last verified: Mar 2026
First submitted: 20 Nov 2024
Last updated: 5 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

De-la-Cruz-Torres B, Romero-Rodriguez B, Romero-Morales C. Ultrasound-Guided Percutaneous Needle Electrolysis Combined With Therapeutic Exercise May Add Benefit in the Management of Soleus Injury in Female Soccer Players: A Pilot Study. J Sport Rehabil. 2022 Nov 21;32(3):265-271. doi: 10.1123/jsr.2022-0021. Print 2023 Mar 1.
PubMed 36410342
Lopez-Martos R, Gonzalez-Perez LM, Ruiz-Canela-Mendez P, Urresti-Lopez FJ, Gutierrez-Perez JL, Infante-Cossio P. Randomized, double-blind study comparing percutaneous electrolysis and dry needling for the management of temporomandibular myofascial pain. Med Oral Patol Oral Cir Bucal. 2018 Jul 1;23(4):e454-e462. doi: 10.4317/medoral.22488.
PubMed 29924769
De-la-Cruz-Torres B, Barrera-Garcia-Martin I, Valera-Garrido F, Minaya-Munoz F, Romero-Morales C. Ultrasound-Guided Percutaneous Needle Electrolysis in Dancers with Chronic Soleus Injury: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2020 Aug 27;2020:4156258. doi: 10.1155/2020/4156258. eCollection 2020.
PubMed 32908559
Vicente-Vega C, Barbero-Iglesias FJ, Martin-Vallejo J, Varela-Rodriguez S. Effectiveness of percutaneous electrolysis in subacute and early chronic medial gastrocnemius muscle injuries: a single-blinded randomized clinical trial. Front Med (Lausanne). 2026 Mar 13;13:1757222. doi: 10.3389/fmed.2026.1757222. eCollection 2026.
PubMed 41907266

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Muscle Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Percutaneous Electrolysis in Subacute and Early Chronic Medial Gastrocnemius Muscle Injuries: A Single-Blinded Randomized Clinical Trial.
ClinicalTrials.gov ID: NCT06713200
Acronym / sponsor ID: PI 2023 08 1418 - TD
Conditions: Muscle Injury, Fibrosis
Keywords: TENNIS LEG, GASTROCNEMIOUS INJURY, FIBROSIS, PERCUTANEOUS ELECTROLYSIS
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: University of SalamancaUniversity, hospital or other
Study start: 26 Nov 2024 (actual)
Primary completion: 27 Mar 2025 (actual)
Study completion: 12 Jun 2025 (actual)
First posted: 3 Dec 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3
Model description: The study will include pacients randomized into three treatment groups: high-intensity percutaneous electrolysis, low-intensity and a control group with sham treatment.

Arm	Type	Receives
Subjects treated with high-intensity percutaneous electrolysis.	Active comparator	Procedure: High intensity percutaneous electrolysisAll 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.
Subjects treated with low intensity percutaneous electrolysis.	Active comparator	Procedure: Low intensity Percutaneous ElectrolysisAll 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.
Subjects treated with simulated percutaneous electrolysis	Sham comparator	Procedure: Simulated Percutaneous ElectrolysisAll 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
High intensity percutaneous electrolysisA 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.	Procedure or surgery	Subjects treated with high-intensity percutaneous electrolysis.
Low intensity Percutaneous ElectrolysisThis 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.	Procedure or surgery	Subjects treated with low intensity percutaneous electrolysis.
Simulated Percutaneous ElectrolysisThe 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.	Procedure or surgery	Subjects treated with simulated percutaneous electrolysis

Primary outcome

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.
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.
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.
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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
Background: PubMed 36410342De-la-Cruz-Torres B, Romero-Rodriguez B, Romero-Morales C. Ultrasound-Guided Percutaneous Needle Electrolysis Combined With Therapeutic Exercise May Add Benefit in the Management of Soleus Injury in Female Soccer Players: A Pilot Study. J Sport Rehabil. 2022 Nov 21;32(3):265-271. doi: 10.1123/jsr.2022-0021. Print 2023 Mar 1.
Background: PubMed 29924769Lopez-Martos R, Gonzalez-Perez LM, Ruiz-Canela-Mendez P, Urresti-Lopez FJ, Gutierrez-Perez JL, Infante-Cossio P. Randomized, double-blind study comparing percutaneous electrolysis and dry needling for the management of temporomandibular myofascial pain. Med Oral Patol Oral Cir Bucal. 2018 Jul 1;23(4):e454-e462. doi: 10.4317/medoral.22488.
Background: PubMed 32908559De-la-Cruz-Torres B, Barrera-Garcia-Martin I, Valera-Garrido F, Minaya-Munoz F, Romero-Morales C. Ultrasound-Guided Percutaneous Needle Electrolysis in Dancers with Chronic Soleus Injury: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2020 Aug 27;2020:4156258. doi: 10.1155/2020/4156258. eCollection 2020.
Derived from this study: PubMed 41907266Vicente-Vega C, Barbero-Iglesias FJ, Martin-Vallejo J, Varela-Rodriguez S. Effectiveness of percutaneous electrolysis in subacute and early chronic medial gastrocnemius muscle injuries: a single-blinded randomized clinical trial. Front Med (Lausanne). 2026 Mar 13;13:1757222. doi: 10.3389/fmed.2026.1757222. eCollection 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fausto Barbero-Iglesias, Doctor study director

University of Salamanca

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain at rest (time frame: From admission to the end of treatment at 28 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06713200, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.