Ultrasound-guided Percutaneous Electrical Stimulation for Gluteus Muscle Dysfunction After Low Back Pain Episode

NCT06873386 | Not Yet Recruiting

• 1 other identifier: C.I. PI24/578
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Percutaneous ultrasound-guided neuromodulation (US-guided PNM) is the electrical stimulation of a peripheral nerve at some point along its pathway or at a muscular motor point under the guidance of an ultrasound probe with a therapeutic objective. The application of electrical current to a peripheral motor nerve is associated with a motor response that results in an uncontrolled, anarchic and exaggerated response of the musculature, which is normalized after the application of the electrical current. In 2016, the authors of the book Invasive Physiotherapy, Fermín Valera and Francisco Minaya, developed by themselves based on the fundamentals of segmental dry needling and neurofunctional acupuncture created by Dr. Alejandro Elorriaga. The authors defined that the application parameters to achieve the best result to the electrical stimulus are controversial, due to the high variability in the literature, but knowing that the most important parameter is the frequency, where studies are observed in which they have used from 2 to 100Hz looking for the motor response. The parameters of the protocol created are: frequency of 10Hz, pulse width of 250us, with a motor or sensory response, performing 8 stimulations of 8 seconds duration, with 8 seconds of rest, with the aim of improving neuromuscular function, muscle recruitment patterns and motor control. Although the scientific basis of the authors were 3 articles, none of which were aimed at improving muscle function, but were for neuropathic pain, chronic pain, and treatment of overactive bladder, the basis of clinical observation is correct and many studies currently using their protocol show improvements at the functional level. In a review of neuromodulation and muscle function, studies that carry out percutaneous stimulation use frequencies of 2Hz to 10Hz, using the protocol of Garrido F. V., Muñoz F. M. , which, as stated above, was not specifically designed to improve muscle function, while the studies that carry out transcutaneous stimulation use much higher frequencies, from 20Hz to 100Hz, all obtaining positive results. For this reason, and the great difference between the frequencies, the need to carry out specific research on the benefits that percutaneous stimulation with a frequency range of 20-100 HZ. The hypotheses of this study are,US-guided PNM, with frequency sweeps of 20Hz -100Hz increases static and dynamic strength, more relevantly than current 10Hz protocols.

Conditions

Low Back Pain; Functional Motor Disorder

Keywords

Low back pain; Muscle dysfunction; Neuromodulation; Nercutaneous ultrasound-guided neuromodulation; Neuromuscular activation; gluteal dysfunction after low back pain

Outcome Measures

Primary Outcomes (1)

• Dynamic strength gluteus

  digital dynamometer, Wagner Force TenTM Digital Force Cage Algometer, FPX25, Massachusetts, USA.

  Baseline, immediately post intervention, 15 days post intervention, 30 days post intervention

Secondary Outcomes (8)

• Isometric strenght gluteous

  Baseline, immediately post intervention, 15 days post intervention, 30 days post intervention

• Contraction speed

  Baseline, immediately post intervention, 15 days post intervention, 30 days post intervention

• Fatigue resistance

  Baseline, immediately post intervention, 15 days post intervention, 30 days post intervention

• Power

  Baseline, immediately post intervention, 15 days post intervention, 30 days post intervention

• Jump

  Baseline, immediately post intervention, 15 days post intervention, 30 days post intervention

Study Arms (2)

Valera & Minaya protocol

ACTIVE COMPARATOR

US-guided PNM with the conventional frequency of the Valera Minaya protocol, with localised location on the peripheral nerve. Stimulation of the upper gluteal nerve and lower gluteal nerve will be performed, with 10 stimulations, with 10 seconds of stimulation and 10 seconds of rest, at a frequency of 10 Hz, with a pulse amplitude of 250 μs, and of maximum intensity tolerable by the patient that causes an exacerbated muscle contraction.

Device: Valera & Minaya protocol

High-frequency PNM

EXPERIMENTAL

High-frequency US-guided PNM with localised peripheral nerve location. Ten 10-second stimulations of the upper gluteal nerve and lower gluteal nerve will be performed, with frequency sweeps of 20Hz -100Hz with a pulse amplitude of 250 μs, and of maximum intensity tolerable by the patient that causes an exacerbated muscle contraction, with 10 seconds of rest between each stimulation.

Device: High-frequency US-guided PNM

Interventions

Valera & Minaya protocol DEVICE

Valera \& Minaya protocol: US-guided PNM with the conventional frequency of the Valera Minaya protocol, with localised location on the peripheral nerve. Stimulation of the upper gluteal nerve and lower gluteal nerve will be performed, with 10 stimulations, with 10 seconds of stimulation and 10 seconds of rest, at a frequency of 10 Hz, with a pulse amplitude of 250 μs, and of maximum intensity tolerable by the patient that causes an exacerbated muscle contraction. The specific device used will be an electric needle stimulator, AS Super 4 Digital, Schwa-medico Holistic Health, Ehringshausen, Germany.

Also known as: convenctional frequency

Valera & Minaya protocol

High-frequency US-guided PNM DEVICE

High-frequency US-guided PNM with localised peripheral nerve location. Ten 10-second stimulations of the upper gluteal nerve and lower gluteal nerve will be performed, with frequency sweeps of 20Hz -100Hz with a pulse amplitude of 250 μs, and of maximum intensity tolerable by the patient that causes an exacerbated muscle contraction, with 10 seconds of rest between each stimulation. The specific device used will be an electric needle stimulator, AS Super 4 Digital, Schwa-medico Holistic Health, Ehringshausen, Germany.

High-frequency PNM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age
• Patients with a history of low back pain, without acute episodes at the time of the study.
• Patients who show an alteration in the function of the gluteus maximus and gluteus medius by EMG.
• Patients who show a decrease in the strength of the gluteus maximus and gluteus medius by dynamometry.
• Patients who have signed the information and consent document for participation.

You may not qualify if:

• Patients with belenophobia.
• Pregnant patients.
• Patients with cardiac pathologies or with pacemakers that do not allow electrical stimulation.
• Patients with low back pain in the acute phase.
• Patients with chronic low back pain.
• Patients with skin or immune disorders with contraindications for the application of invasive techniques.
• Patients who refuse to sign the informed consent or to participate in the study.
• Individuals who are planning a change in their lifestyle that involves a change in relation to physical activity or training.

Sponsors & Collaborators

• Marc Badia: lead

Study Sites (1)

Fiostec Funcional

Sabadell, Barcelona, 08205, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Badia Rosells, Physiotherapist

  Universidad de Zaragoza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Badia Rosells, Physioterapist

CONTACT

+34 605635801; marcbadia.fisio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The principal investigator, who carries out the intervention, is not masked. The participants and the researchers in charge of analysing the outcome variables are masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: physiotherapist

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 12, 2025
• Study Start: April 15, 2025
• Primary Completion: June 15, 2025
• Study Completion: November 15, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)