Myofascial Pain Syndrome (MPS)EPIEMGNCT07351331
Intratissue Electrolysis (EPI) is Effective in Deactivating Myofascial Trigger Points (MTrPs). (EPIEMG)
A study testing Intratissue Percutaneous Electroly and dry needling in people with Myofascial Pain Syndrome (MPS), run by Camilo Jose Cela University at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofascial Pain Syndrome (MPS)
- What is being tested?
- Intratissue Percutaneous Electroly and dry needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 15 Nov 2024to 24 Apr 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
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Myofascial Pain Syndrome (MPS)
- Being tested
- Intratissue Percutaneous Electroly, dry needling
- Keywords
- Percutaneous electrolysis, Dry needling, Myofascial pain syndrome, Flexor hallucis brevis, Electromyography, Pressure platform
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intratissue Percutaneous ElectrolyOther
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.
dry needlingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Percutaneous Intratisular Electrolysis (IPE) | Experimental | 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) . Receives: Other: Intratissue Percutaneous Electroly |
| dry needling (DN) | Experimental | 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) Receives: Other: dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean pressures (MP)
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)
Measured: It was measured at the start of the protocol in week 1, in week 4 and in week 12.
maximum pressures (PMáx)
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)
Measured: It was measured at the start of the protocol in week 1, in week 4 and in week 12.
maximal voluntary contraction (MVC)
The muscular activation is analyzed during 3 sets of 5 seconds of isometric contraction, against the resistance of the examiner's hand
Measured: 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
The subject's position is a protocol that has been previously explained to ensure correct measurement. The subject must walk for 20 seconds
Measured: It was measured at the start of the protocol in week 1, in week 4 and in week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start15 Nov 2024
- Primary completion28 Feb 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain Syndrome (MPS)Studies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Camilo Jose Cela University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- María de Pedro Benito, PhD, Study director, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351331
- Sponsor's protocol ID
- EPIEMG
- Acronym
- EPIEMG
- Status last verified
- Jan 2026
- First submitted
- 17 Nov 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martinez-Jimenez EM, Losa-Iglesias ME, Antolin-Gil MS, Lopez-Lopez D, Romero-Morales C, Benito-de-Pedro M, Calvo-Lobo C, Becerro-de-Bengoa-Vallejo R. Flexor Digitorum Brevis Muscle Dry Needling Changes Surface and Plantar Pressures: A Pre-Post Study. Life (Basel). 2021 Jan 13;11(1):48. doi: 10.3390/life11010048.
PubMed 33451013Rodriguez-Huguet M, Gongora-Rodriguez J, Rodriguez-Huguet P, Ibanez-Vera AJ, Rodriguez-Almagro D, Martin-Valero R, Diaz-Fernandez A, Lomas-Vega R. Effectiveness of Percutaneous Electrolysis in Supraspinatus Tendinopathy: A Single-Blinded Randomized Controlled Trial. J Clin Med. 2020 Jun 12;9(6):1837. doi: 10.3390/jcm9061837.
PubMed 32545583Martinez-Jimenez EM, Losa-Iglesias ME, Mazoteras-Pardo V, Lopez-Lopez D, Pereiro-Buceta H, Calvo-Lobo C, Rodriguez-Sanz D, Becerro-de-Bengoa-Vallejo R, Navarro-Flores E. Dry needling of the flexor digitorum brevis muscle reduces postural control in standing: A pre-post stabilometric study. J Anat. 2023 Sep;243(3):545-554. doi: 10.1111/joa.13862. Epub 2023 Mar 16.
PubMed 36924312Benito-de-Pedro AI, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Rodriguez-Sanz D, Calvo-Lobo C, Benito-de-Pedro M. Efficacy of Deep Dry Needling versus Percutaneous Electrolysis in Ultrasound-Guided Treatment of Active Myofascial Trigger Points of the Levator Scapulae in Short-Term: A Randomized Controlled Trial. Life (Basel). 2023 Apr 3;13(4):939. doi: 10.3390/life13040939.
PubMed 37109468Lopez-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 29924769Galasso A, Urits I, An D, Nguyen D, Borchart M, Yazdi C, Manchikanti L, Kaye RJ, Kaye AD, Mancuso KF, Viswanath O. A Comprehensive Review of the Treatment and Management of Myofascial Pain Syndrome. Curr Pain Headache Rep. 2020 Jun 27;24(8):43. doi: 10.1007/s11916-020-00877-5.
PubMed 32594264
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Intratissue Percutaneous Electrolysis in the Shortening of the Flexor Hallucis Brevis Caused by Myofascial Pain Syndrome. A Pre-post Study.
- ClinicalTrials.gov ID
- NCT07351331
- Acronym / sponsor ID
- EPIEMG / EPIEMG
- Conditions
- Myofascial Pain Syndrome (MPS)
- Keywords
- Percutaneous electrolysis, Dry needling, Myofascial pain syndrome, Flexor hallucis brevis, Electromyography, Pressure platform
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Camilo Jose Cela UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 20 Jan 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Percutaneous Intratisular Electrolysis (IPE) | Experimental | Other: Intratissue Percutaneous ElectrolyTo 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) . |
| dry needling (DN) | Experimental | Other: dry needlingTo 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
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 |
|---|---|---|
| Intratissue Percutaneous ElectrolyThree 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. | Other | Group Percutaneous Intratisular Electrolysis (IPE) |
| dry needlingThree 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. | Other | dry needling (DN) |
Primary outcome
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)
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)
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
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
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 20 Jan 2026.
- Results publication: PubMed 33451013Martinez-Jimenez EM, Losa-Iglesias ME, Antolin-Gil MS, Lopez-Lopez D, Romero-Morales C, Benito-de-Pedro M, Calvo-Lobo C, Becerro-de-Bengoa-Vallejo R. Flexor Digitorum Brevis Muscle Dry Needling Changes Surface and Plantar Pressures: A Pre-Post Study. Life (Basel). 2021 Jan 13;11(1):48. doi: 10.3390/life11010048.
- Results publication: PubMed 32545583Rodriguez-Huguet M, Gongora-Rodriguez J, Rodriguez-Huguet P, Ibanez-Vera AJ, Rodriguez-Almagro D, Martin-Valero R, Diaz-Fernandez A, Lomas-Vega R. Effectiveness of Percutaneous Electrolysis in Supraspinatus Tendinopathy: A Single-Blinded Randomized Controlled Trial. J Clin Med. 2020 Jun 12;9(6):1837. doi: 10.3390/jcm9061837.
- Results publication: PubMed 36924312Martinez-Jimenez EM, Losa-Iglesias ME, Mazoteras-Pardo V, Lopez-Lopez D, Pereiro-Buceta H, Calvo-Lobo C, Rodriguez-Sanz D, Becerro-de-Bengoa-Vallejo R, Navarro-Flores E. Dry needling of the flexor digitorum brevis muscle reduces postural control in standing: A pre-post stabilometric study. J Anat. 2023 Sep;243(3):545-554. doi: 10.1111/joa.13862. Epub 2023 Mar 16.
- Results publication: PubMed 37109468Benito-de-Pedro AI, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Rodriguez-Sanz D, Calvo-Lobo C, Benito-de-Pedro M. Efficacy of Deep Dry Needling versus Percutaneous Electrolysis in Ultrasound-Guided Treatment of Active Myofascial Trigger Points of the Levator Scapulae in Short-Term: A Randomized Controlled Trial. Life (Basel). 2023 Apr 3;13(4):939. doi: 10.3390/life13040939.
- Results publication: 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.
- Results publication: PubMed 32594264Galasso A, Urits I, An D, Nguyen D, Borchart M, Yazdi C, Manchikanti L, Kaye RJ, Kaye AD, Mancuso KF, Viswanath O. A Comprehensive Review of the Treatment and Management of Myofascial Pain Syndrome. Curr Pain Headache Rep. 2020 Jun 27;24(8):43. doi: 10.1007/s11916-020-00877-5.
- 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.
María de Pedro Benito, PhD study director
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intratissue Percutaneous Electroly and dry needling in people with Myofascial Pain Syndrome (MPS), run by Camilo Jose Cela University at 1 site in Spain.
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 5 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 20 Jan 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. 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?
mean pressures (MP) (time frame: It was measured at the start of the protocol in week 1, in week 4 and in week 12.). The study lists 4 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 NCT07351331, which also lists 6 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 20 Jan 2026.