Frequency Parameter Used to Apply Ultrasound-guided Neuromodulation Percutaneous

NCT05106920 | Completed

• 1 other identifier: NMP-Frequency
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In the daily clinical practice, one of the most frequent reasons for consultation physiotherapists is low back pain (LBP). Regardless of the origin of the problem, the approach from physiotherapy contemplates the reduction of pain through different procedures, including neuromodulation. In the field of Physiotherapy, ultrasound-guided Percutaneous Neuromodulation (PNM) is defined as the application through a needle with ultrasound guidance of an electrical current at low or medium frequency, seeking a sensitive and / or motor response of a peripheral nerve in some point of its trajectory, or of a muscle in a motor point, with a therapeutic objective. The objective of the study is to analyze that the effect of PNM on the sciatic nerve produces statistically significant changes in pain, joint range and functionality in patients with chronic LBP. Forty subjects will be recruited, which will be divided into 2 groups: group 1 to which PNM will be applied to the sciatic nerve at 250 microseconds, 3 Hz) during 90 seconds; group 2 to which PNM will be applied to the sciatic nerve in at 250 microseconds, 10 Hz during 90 second. The PNM intervention with NMP will consist in the single application of an asymmetric rectangular biphasic current.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (5)

• Level of pain

  Measured by Visual Analogue Scale (0, no pain; 100, max pain)

  From baseline measurement up to 1 week

• Owestry questionnaire

  Lower back pain questionnaire. The final result is classified as minimal disability (0-20), moderate disability (21-40), severe disability (41-60), crippled (61-80) and bed-bound or exaggerating their symptoms (81-100).

  From baseline measurement up to 1 week

• Range of motion

  Measured by goniometer. Hip flexion, external and internal rotation range of motion

  From baseline measurement up to 1 week

• Y Balance Test

  Stability body

  From baseline measurement up to 1 week

• Strength

  Measured by dynamometer. Hip flexion, abduction, external and internal rotation muscle strength

  From baseline measurement up to 1 week

Study Arms (2)

NMP 3 Hz

EXPERIMENTAL

Participants received the percutaneous electrical stimulation intervention. Specifically, this consisted of the application of a square wave biphasic electrical current, with 3 Hz frequency and a 250µs pulse width, at the maximal tolerable intensity, to cause an tolerable muscle contraction. The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations. A trained physiotherapist performed the PNM intervention.

Other: NMP

NMP 10 Hz

EXPERIMENTAL

Participants received the percutaneous electrical stimulation intervention. Specifically, this consisted of the application of a square wave biphasic electrical current, with 10 Hz frequency and a 250µs pulse width, at the maximal tolerable intensity, to cause an tolerable muscle contraction. The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations. A trained physiotherapist performed the PNM intervention.

Other: NMP

Interventions

NMP OTHER

Participants received the percutaneous electrical stimulation intervention. Specifically, this consisted of the application of a square wave biphasic electrical current, to cause a tolerable muscle contraction. The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations. A trained physiotherapist performed the PNM intervention.

NMP 10 Hz; NMP 3 Hz

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Lower Back Pain
• Having no other therapy

You may not qualify if:

• Other pathology (discal hernia, injured limbs, neurological pathology)
• Belenophobia

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

University of Seville

Seville, 41009, 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 23, 2021
• First Posted: November 4, 2021
• Study Start: November 3, 2021
• Primary Completion: November 3, 2021
• Study Completion: November 1, 2023
• Last Updated: December 26, 2023

Record last verified: 2023-12

Locations

ES (1)