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Completed

NCT Number: NCT05106920

Frequency Parameter Used to Apply Ultrasound-guided Neuromodulation Percutaneous

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Seville

Seville, 41009, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Lower Back Pain
  • Having no other therapy

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Level of pain

    Time frame: From baseline measurement up to 1 week

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

  2. Owestry questionnaire

    Time frame: From baseline measurement up to 1 week

    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).

  3. Range of motion

    Time frame: From baseline measurement up to 1 week

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

  4. Y Balance Test

    Time frame: From baseline measurement up to 1 week

    Stability body

  5. Strength

    Time frame: From baseline measurement up to 1 week

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

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

How we Apply Ultrasound-guided Neuromodulation in Lower Back Pain Sufferers

Acronym: Parameters NMP

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Nov 4, 2021
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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