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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarc Badia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients over 18 years of age

Healthy patients at the time of inclusion selection.

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Valera & Minaya protocolActive comparator 1 intervention
Group B: High-frequency PNMExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dynamic strength gluteus

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

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

Secondary outcomes

1

Isometric strenght gluteous

Isometric strenght gluteous, traction dynamometer (MicroFet2 hand-held dynamometer, Hoggan Health Industries, Biometrics, Netherlands) or (Force sensor, Chronojump, Boscosystem, Barcelona, Spain).

Time frame
Baseline, immediately post intervention, 15 days post intervention, 30 days post intervention
2

Contraction speed

Gluteus contraction speed (Encoder lineal Chronojump, Boscosystem, Barcelona, España).

Time frame
Baseline, immediately post intervention, 15 days post intervention, 30 days post intervention
3

Fatigue resistance

Gluteus fatigue resistance with repetitions

Time frame
Baseline, immediately post intervention, 15 days post intervention, 30 days post intervention
4

Power

Gluteus power (rotary encoder, Chronojump, Boscosystem, Barcelona, Spain)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marc Badia

Lead sponsor

Universidad de Zaragoza

Sponsor institution