Intratissue Electrolysis (EPI) is Effective in Deactivating Myofascial Trigger Points (MTrPs). (EPIEMG) (EPIEMG)

January 10, 2026 updated by: Camilo Jose Cela University

The Effectiveness of Intratissue Percutaneous Electrolysis in the Shortening of the Flexor Hallucis Brevis Caused by Myofascial Pain Syndrome. A Pre-post Study.

Invasive physiotherapy techniques, such as Intratissue Percutaneous Electroly-sis (IPE), have numerous beneficial effects depending on the pathology being treated, in-cluding the deactivation of myofascial trigger points (MTP) caused by myofascial pain syndrome (MPS).

The objectives are (1) evaluate the effectiveness of low intesity IPE treatment com-pared to DN on the shortening of FHB in patients with MPS, in 4 and 12 weeks evaluation, (2) assess the distribution of plantar pressures after the interventions and (3) evaluate the modification of FHB activation following the interventions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients are divided into two intervention groups (IPE; n=18) and (DN; n=22). Before the intervention, variables of mean and maximum pressure are measured in all patients using a pressure platform, and neuromuscular activity is assessed through surface electromy-ography (sEMG). These measures are repeated at 4- and 12-weeks post-intervention. The results show efficacy in both techniques, with significant differences at both 4 weeks and 12 weeks in favor of the IPE group, both in plantar pressure distribution and muscular activity.

The first measurement (week of November 25, 2024) is considered the baseline measurement since the subjects had not been previously intervened. Therefore, the measurement is first performed using the pressure platform and sEMG, followed by the intervention of DN or IPE based on the group to which the subjects were previously as-signed.

At week 4 from the first measurement (week of December 23, 2024), the second data collection is conducted, using the same procedure as in the first measurement.

At week 12 from the initial measurement (week of February 17, 2025), the third data collection takes place using the same procedure as the previous two, with the difference that in this final measurement there will be no intervention of DN or IPE.

Study Type

Interventional

Enrollment (Actual)

40

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
      • Madrid, Spain
        • Universidad Camilo José Cela

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:

  • subjects with ages between 18 and 65 years,
  • hypersensitive spot within a taut band in FHB muscle.
  • pain upon stimulation of the MTP.
  • painful limit to the full range of motion

Exclusion Criteria:

  • subjets who had bilateral LTP present.
  • who have had a lower limb injury or surgery within the last 6 months.
  • subjectss with active pathologies at the time of measurement in the lower limb.
  • subjectss with cognitive impairment.
  • subjectss with belonephobia or contraindications for the use of needles (oral anticoagulant therapy).

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
Experimental: Group Percutaneous Intratisular Electrolysis (IPE)
To perform the intervention correctly, whether for DN or IPE, the patient is positioned in a prone position. followed by disinfection with an antiseptic applied to the region to be addressed, with the therapist always wearing gloves as protection. Once the respective treatment is completed, pressure is applied to the needle entry point for 30 seconds. The IPE intervention is performed with the Physio Invasiva® device (Enraf Nonius Ibérica S.A., Madrid, Spain), following the same approach as in the DN, with gloves worn and the region disinfected beforehand. The tense band is located to introduce the needle into the nodule, attempting to elicit a LTR produced by an MTP (20,34,37,38) , Galvanic current is then applied, with 3 pulses of 5 seconds each at an intensity of 1.5 milliamperes (mA) and current interruption between each pulse (34) , differing from other studies that apply 3 mA or more (37,38) .
Other: Intratissue Percutaneous Electroly
Three interventions were performed, the first in the initial week, after pressure and sEMG measurements, the second in week 4, and the third in week 12.
Experimental: dry needling (DN)
To perform the intervention correctly, whether for DN or IPE, the patient is positioned in a prone position. followed by disinfection with an antiseptic applied to the region to be addressed, with the therapist always wearing gloves as protection. Once the respective treatment is completed, pressure is applied to the needle entry point for 30 seconds. The intervention with DN is performed using the "quick entries and exits technique of Hong" (35) , with gloves and alcohol disinfectant applied to the region to be treated, in this case, the internal part of the plantar foot (FHB) (33) . Next, the taud band of the FHB muscle is located, and a palpable nodule that is painful to mechanical stimulation is identified in the taud band. The needle is then inserted into the nodule to perform the "quick entry and exit technique" (34) , with 4 entries and exits performed on the FHB, aiming to provoke local twich responses (LTR)
Other: dry needling
Three interventions were performed, the first in the initial week, after pressure and sEMG measurements, the second in week 4, and the third in week 12.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean pressures (MP)
Time Frame: It was measured at the start of the protocol in week 1, in week 4 and in week 12.
it is the average value of the pressure measured on a pressure platform, representing the general distribution of force per unit area across a surface (g/cm²)
It was measured at the start of the protocol in week 1, in week 4 and in week 12.
maximum pressures (PMáx)
Time Frame: It was measured at the start of the protocol in week 1, in week 4 and in week 12.
it is the highest pressure value recorded on the pressure platform, indicating the point of greatest concentration of force per unit area on the evaluated surface.(g/cm²)
It was measured at the start of the protocol in week 1, in week 4 and in week 12.
maximal voluntary contraction (MVC)
Time Frame: It was measured at the start of the protocol in week 1, in week 4 and in week 12.
The muscular activation is analyzed during 3 sets of 5 seconds of isometric contraction, against the resistance of the examiner's hand
It was measured at the start of the protocol in week 1, in week 4 and in week 12.
dynamic muscular activation of the FHB
Time Frame: It was measured at the start of the protocol in week 1, in week 4 and in week 12.
The subject's position is a protocol that has been previously explained to ensure correct measurement. The subject must walk for 20 seconds
It was measured at the start of the protocol in week 1, in week 4 and in week 12.

Collaborators and Investigators

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

Sponsor

Camilo Jose Cela University

Investigators

  • Study Director: María de Pedro Benito, PhD, Associate professor

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 15, 2024

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

April 24, 2025

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

January 10, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 10, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPIEMG

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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