NCT07351331

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

November 17, 2025

Last Update Submit

January 10, 2026

Conditions

Keywords

Percutaneous electrolysisDry needlingMyofascial pain syndromeFlexor hallucis brevisElectromyographyPressure platform

Outcome Measures

Primary Outcomes (4)

  • 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)

    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)

    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

    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

    It was measured at the start of the protocol in week 1, in week 4 and in week 12.

Study Arms (2)

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) .

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)

Other: dry needling

Interventions

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.

Group Percutaneous Intratisular Electrolysis (IPE)

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 needling (DN)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Camilo José Cela

Madrid, Spain

Location

Related Publications (6)

  • 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.

  • Rodriguez-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.

  • Martinez-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.

  • Benito-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.

  • 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.

  • Galasso 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.

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • María de Pedro Benito, PhD

    Associate Professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

January 20, 2026

Study Start

November 15, 2024

Primary Completion

February 28, 2025

Study Completion

April 24, 2025

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations