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Frequency Parameter Used to Apply Ultrasound-guided Neuromodulation Percutaneous (Parameters NMP)

Primary Purpose

Low Back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NMP
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosis of Lower Back Pain
  • Having no other therapy

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    NMP 3 Hz

    NMP 10 Hz

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Level of pain
    Measured by Visual Analogue Scale (0, no pain; 100, max pain)
    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).
    Range of motion
    Measured by goniometer. Hip flexion, external and internal rotation range of motion
    Y Balance Test
    Stability body
    Strength
    Measured by dynamometer. Hip flexion, abduction, external and internal rotation muscle strength

    Secondary Outcome Measures

    Full Information

    First Posted
    October 23, 2021
    Last Updated
    November 4, 2021
    Sponsor
    University of Seville
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05106920
    Brief Title
    Frequency Parameter Used to Apply Ultrasound-guided Neuromodulation Percutaneous
    Acronym
    Parameters NMP
    Official Title
    How we Apply Ultrasound-guided Neuromodulation in Lower Back Pain Sufferers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 3, 2021 (Anticipated)
    Primary Completion Date
    November 3, 2021 (Anticipated)
    Study Completion Date
    March 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Seville

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NMP 3 Hz
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    NMP 10 Hz
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    NMP
    Intervention Description
    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 Outcome Measure Information:
    Title
    Level of pain
    Description
    Measured by Visual Analogue Scale (0, no pain; 100, max pain)
    Time Frame
    From baseline measurement up to 1 week
    Title
    Owestry questionnaire
    Description
    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).
    Time Frame
    From baseline measurement up to 1 week
    Title
    Range of motion
    Description
    Measured by goniometer. Hip flexion, external and internal rotation range of motion
    Time Frame
    From baseline measurement up to 1 week
    Title
    Y Balance Test
    Description
    Stability body
    Time Frame
    From baseline measurement up to 1 week
    Title
    Strength
    Description
    Measured by dynamometer. Hip flexion, abduction, external and internal rotation muscle strength
    Time Frame
    From baseline measurement up to 1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of Lower Back Pain Having no other therapy Exclusion Criteria: Other pathology (discal hernia, injured limbs, neurological pathology) Belenophobia

    12. IPD Sharing Statement

    Learn more about this trial

    Frequency Parameter Used to Apply Ultrasound-guided Neuromodulation Percutaneous

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