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PNS vs RFA for Facet Joint Pain

Primary Purpose

Facet Joint Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sprint PNS system
Radiofrequency Ablation
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Facet Joint Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age range (18-80 years): The age range of the patient population at Hershey Medical Center with facet pain is 24 to 90 years old, with a mean age of 63 years old. Due to the physical tests planned in the study, the maximum age limit will be restricted to 80 years old. English Speaking: Adults who only speak other languages will not be included because of the lack of feasibility of employing reliable instruments and interviewers fluent in other languages. Facet Joint Pain: male and female patients having a diagnosis of facet joint pain based upon accepted diagnostic criteria (i.e., two positive nerve blocks) and assessed by an experienced physical therapist or physician. Indication for Surgical Procedure: Physical therapy is the first line of action for facet joint pain. If PT is not effective, patients are eligible for RFA or PNS. Exclusion Criteria: Previous Spinal Conditions Surgery: We will exclude patients with other spinal conditions like scoliosis or who have received previous spinal surgeries. Systemic neurological or neuromuscular disease: Such disorders (e.g., stroke, muscular dystrophy, myopathies) affect muscle and may confound muscle data and/or balance and physical performance data. Allergic reaction to ultrasound gels: It is possible, although rare, that patients develop allergic reaction to ultrasound gels. Those subjects will be excluded from the study. Physical Activity: Subjects will be asked to fill out the Physical Activity Readiness Questionnaire (PAR-Q), and if they answer yes to any of the questions, they need to be cleared by their physician prior to participating in the study. Current infection, illness, or condition: Individuals with a current infection, illness, or condition (e.g., uncontrolled blood pressure, pregnancy) that may affect their ability to safely participate will be excluded. Mental incompetency: Individuals who cannot legally consent themselves to the surgical procedure and participation in the research study, will not be considered for inclusion. Patients who have a Deep Brain Stimulation (DBS) system. Patients who have an implanted active cardiac implant (e.g. pacemaker or defibrillator). Patients who have any other implantable neuro-stimulator whose stimulus current pathway may overlap with that of the SPRINT System.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Peripheral Nerve Stimulation

    Radiofrequency Ablation

    Arm Description

    Peripheral nerve stimulation (PNS) is a procedure used to relieve chronic back pain by targeting the nerves responsible for transmitting pain signals from the back to the brain. It is a minimally invasive approach that aims to disrupt the pain signals and provide pain relief.

    Radiofrequency ablation (RFA) is the current standard of care for facet joint pain. It is a minimally invasive procedure used to relieve chronic back or neck pain caused by issues with the small joints in the spine called facet joints.

    Outcomes

    Primary Outcome Measures

    Multifidus muscle activity
    Muscle contraction quantification via shear wave elastography
    Multifidus muscle activity
    Muscle contraction quantification via shear wave elastography
    Multifidus muscle activity
    Muscle contraction quantification via shear wave elastography

    Secondary Outcome Measures

    Pain Intensity
    Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain.
    Pain Intensity
    Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain.
    Pain Intensity
    Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain.
    Oswestry Disability Index
    Survey evaluating disability level, 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled
    Oswestry Disability Index
    Survey evaluating disability level, 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled
    Oswestry Disability Index
    Survey evaluating disability level, 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled
    PROMIS-29 v2.0
    Survey assessing pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance)
    PROMIS-29 v2.0
    Survey assessing pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance)
    PROMIS-29 v2.0
    Survey assessing pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance)
    isometric back strength
    Measurement of peak force generated by the torso in extension in Newtons
    Isometric back strength
    Measurement of peak force generated by the torso in extension in Newtons
    isometric back strength
    Measurement of peak force generated by the torso in extension in Newtons
    Functional Reach
    distance between the length of an outstretched arm in a maximal forward reach, 10"/25 cm or greater Low risk of falls, 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal, 6"/15cm or less Risk of falling is 4x greater than normal, Unwilling to reach Risk of falling is 8x greater than normal.
    Functional Reach
    distance between the length of an outstretched arm in a maximal forward reach, 10"/25 cm or greater Low risk of falls, 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal, 6"/15cm or less Risk of falling is 4x greater than normal, Unwilling to reach Risk of falling is 8x greater than normal.
    Functional Reach
    distance between the length of an outstretched arm in a maximal forward reach, 10"/25 cm or greater Low risk of falls, 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal, 6"/15cm or less Risk of falling is 4x greater than normal, Unwilling to reach Risk of falling is 8x greater than normal.
    Repetitive Trunk Rotation
    Time to complete 20 rotations, seconds, longer times are worse performance.
    Repetitive Trunk Rotation
    Time to complete 20 rotations, seconds, longer times are worse performance.
    Repetitive Trunk Rotation
    Time to complete 20 rotations, seconds, longer times are worse performance.
    Repeated Chair Stands
    Time to perform 5 repeated chair stands, higher times mean worse outcomes.
    Repeated Chair Stands
    Time to perform 5 repeated chair stands, higher times mean worse outcomes.
    Repeated Chair Stands
    Time to perform 5 repeated chair stands, higher times mean worse outcomes.
    Pfirmmann grade
    Degeneration of lumbar discs at the treated level, grade 1 - 5, 1 is normal and 5 is completely collapsed disc.
    Pfirmmann grade
    Degeneration of lumbar discs at the treated level, grade 1 - 5, 1 is normal and 5 is completely collapsed disc.
    Pfirmmann grade
    Degeneration of lumbar discs at the treated level, grade 1 - 5, 1 is normal and 5 is completely collapsed disc.
    t2-relaxation time
    T2 relaxation time of the disc at the treated level. Lower values indicate more degeneration.
    t2-relaxation time
    T2 relaxation time of the disc at the treated level. Lower values indicate more degeneration.
    t2-relaxation time
    T2 relaxation time of the disc at the treated level. Lower values indicate more degeneration.
    2-point dixon MRI
    Intramuscular fat percentage, higher percentage means worse outcome.
    2-point dixon MRI
    Intramuscular fat percentage, higher percentage means worse outcome.
    2-point dixon MRI
    Intramuscular fat percentage, higher percentage means worse outcome.

    Full Information

    First Posted
    June 15, 2023
    Last Updated
    July 11, 2023
    Sponsor
    Penn State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05952518
    Brief Title
    PNS vs RFA for Facet Joint Pain
    Official Title
    Evaluation of Peripheral Nerve Stimulation as an Alternative to Radiofrequency Ablation for Facet Joint Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    October 2026 (Anticipated)
    Study Completion Date
    October 2027 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    Radiofrequency ablation of the medial nerve is the current surgical treatment for back pain originating from the facet joints in the spine. However, this procedure causes denervation of spinal muscles. Peripheral nerve stimulation is another treatment for facet joint pain that may not cause damage to the spinal muscles. This study will compare both treatments in terms pain relief and spine biomechanics.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Facet Joint Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Peripheral Nerve Stimulation
    Arm Type
    Experimental
    Arm Description
    Peripheral nerve stimulation (PNS) is a procedure used to relieve chronic back pain by targeting the nerves responsible for transmitting pain signals from the back to the brain. It is a minimally invasive approach that aims to disrupt the pain signals and provide pain relief.
    Arm Title
    Radiofrequency Ablation
    Arm Type
    Active Comparator
    Arm Description
    Radiofrequency ablation (RFA) is the current standard of care for facet joint pain. It is a minimally invasive procedure used to relieve chronic back or neck pain caused by issues with the small joints in the spine called facet joints.
    Intervention Type
    Device
    Intervention Name(s)
    Sprint PNS system
    Intervention Description
    Temporary electrical stimulation of the medial nerve with implanted wires and wearable stimulator
    Intervention Type
    Procedure
    Intervention Name(s)
    Radiofrequency Ablation
    Intervention Description
    Thermal ablation of the medial nerve
    Primary Outcome Measure Information:
    Title
    Multifidus muscle activity
    Description
    Muscle contraction quantification via shear wave elastography
    Time Frame
    pre-treatment
    Title
    Multifidus muscle activity
    Description
    Muscle contraction quantification via shear wave elastography
    Time Frame
    within two weeks of treatment completion
    Title
    Multifidus muscle activity
    Description
    Muscle contraction quantification via shear wave elastography
    Time Frame
    12 months after pre-treatment measurement
    Secondary Outcome Measure Information:
    Title
    Pain Intensity
    Description
    Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain.
    Time Frame
    pre-treatment
    Title
    Pain Intensity
    Description
    Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain.
    Time Frame
    within two weeks of treatment completion
    Title
    Pain Intensity
    Description
    Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain.
    Time Frame
    12 months after pre-treatment measurement
    Title
    Oswestry Disability Index
    Description
    Survey evaluating disability level, 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled
    Time Frame
    pre-treatment
    Title
    Oswestry Disability Index
    Description
    Survey evaluating disability level, 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled
    Time Frame
    within two weeks of treatment completion
    Title
    Oswestry Disability Index
    Description
    Survey evaluating disability level, 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled
    Time Frame
    12 months after pre-treatment measurement
    Title
    PROMIS-29 v2.0
    Description
    Survey assessing pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance)
    Time Frame
    pre-treatment
    Title
    PROMIS-29 v2.0
    Description
    Survey assessing pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance)
    Time Frame
    within two weeks of treatment completion
    Title
    PROMIS-29 v2.0
    Description
    Survey assessing pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance)
    Time Frame
    12 months after pre-treatment measurement
    Title
    isometric back strength
    Description
    Measurement of peak force generated by the torso in extension in Newtons
    Time Frame
    pre-treatment
    Title
    Isometric back strength
    Description
    Measurement of peak force generated by the torso in extension in Newtons
    Time Frame
    within two weeks of treatment completion
    Title
    isometric back strength
    Description
    Measurement of peak force generated by the torso in extension in Newtons
    Time Frame
    12 months after pre-treatment measurement
    Title
    Functional Reach
    Description
    distance between the length of an outstretched arm in a maximal forward reach, 10"/25 cm or greater Low risk of falls, 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal, 6"/15cm or less Risk of falling is 4x greater than normal, Unwilling to reach Risk of falling is 8x greater than normal.
    Time Frame
    pre-treatment
    Title
    Functional Reach
    Description
    distance between the length of an outstretched arm in a maximal forward reach, 10"/25 cm or greater Low risk of falls, 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal, 6"/15cm or less Risk of falling is 4x greater than normal, Unwilling to reach Risk of falling is 8x greater than normal.
    Time Frame
    within two weeks of treatment completion
    Title
    Functional Reach
    Description
    distance between the length of an outstretched arm in a maximal forward reach, 10"/25 cm or greater Low risk of falls, 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal, 6"/15cm or less Risk of falling is 4x greater than normal, Unwilling to reach Risk of falling is 8x greater than normal.
    Time Frame
    12 months after pre-treatment measurement
    Title
    Repetitive Trunk Rotation
    Description
    Time to complete 20 rotations, seconds, longer times are worse performance.
    Time Frame
    pre-treatment
    Title
    Repetitive Trunk Rotation
    Description
    Time to complete 20 rotations, seconds, longer times are worse performance.
    Time Frame
    within two weeks of treatment completion
    Title
    Repetitive Trunk Rotation
    Description
    Time to complete 20 rotations, seconds, longer times are worse performance.
    Time Frame
    12 months after pre-treatment measurement
    Title
    Repeated Chair Stands
    Description
    Time to perform 5 repeated chair stands, higher times mean worse outcomes.
    Time Frame
    pre-treatment
    Title
    Repeated Chair Stands
    Description
    Time to perform 5 repeated chair stands, higher times mean worse outcomes.
    Time Frame
    within two weeks of treatment completion
    Title
    Repeated Chair Stands
    Description
    Time to perform 5 repeated chair stands, higher times mean worse outcomes.
    Time Frame
    12 months after pre-treatment measurement
    Title
    Pfirmmann grade
    Description
    Degeneration of lumbar discs at the treated level, grade 1 - 5, 1 is normal and 5 is completely collapsed disc.
    Time Frame
    pre-treatment
    Title
    Pfirmmann grade
    Description
    Degeneration of lumbar discs at the treated level, grade 1 - 5, 1 is normal and 5 is completely collapsed disc.
    Time Frame
    within two weeks of treatment completion
    Title
    Pfirmmann grade
    Description
    Degeneration of lumbar discs at the treated level, grade 1 - 5, 1 is normal and 5 is completely collapsed disc.
    Time Frame
    12 months after pre-treatment measurement
    Title
    t2-relaxation time
    Description
    T2 relaxation time of the disc at the treated level. Lower values indicate more degeneration.
    Time Frame
    pre-treatment
    Title
    t2-relaxation time
    Description
    T2 relaxation time of the disc at the treated level. Lower values indicate more degeneration.
    Time Frame
    within two weeks of treatment completion
    Title
    t2-relaxation time
    Description
    T2 relaxation time of the disc at the treated level. Lower values indicate more degeneration.
    Time Frame
    12 months after pre-treatment measurement
    Title
    2-point dixon MRI
    Description
    Intramuscular fat percentage, higher percentage means worse outcome.
    Time Frame
    pre-treatment
    Title
    2-point dixon MRI
    Description
    Intramuscular fat percentage, higher percentage means worse outcome.
    Time Frame
    within two weeks of treatment completion
    Title
    2-point dixon MRI
    Description
    Intramuscular fat percentage, higher percentage means worse outcome.
    Time Frame
    12 months after pre-treatment measurement

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age range (18-80 years): The age range of the patient population at Hershey Medical Center with facet pain is 24 to 90 years old, with a mean age of 63 years old. Due to the physical tests planned in the study, the maximum age limit will be restricted to 80 years old. English Speaking: Adults who only speak other languages will not be included because of the lack of feasibility of employing reliable instruments and interviewers fluent in other languages. Facet Joint Pain: male and female patients having a diagnosis of facet joint pain based upon accepted diagnostic criteria (i.e., two positive nerve blocks) and assessed by an experienced physical therapist or physician. Indication for Surgical Procedure: Physical therapy is the first line of action for facet joint pain. If PT is not effective, patients are eligible for RFA or PNS. Exclusion Criteria: Previous Spinal Conditions Surgery: We will exclude patients with other spinal conditions like scoliosis or who have received previous spinal surgeries. Systemic neurological or neuromuscular disease: Such disorders (e.g., stroke, muscular dystrophy, myopathies) affect muscle and may confound muscle data and/or balance and physical performance data. Allergic reaction to ultrasound gels: It is possible, although rare, that patients develop allergic reaction to ultrasound gels. Those subjects will be excluded from the study. Physical Activity: Subjects will be asked to fill out the Physical Activity Readiness Questionnaire (PAR-Q), and if they answer yes to any of the questions, they need to be cleared by their physician prior to participating in the study. Current infection, illness, or condition: Individuals with a current infection, illness, or condition (e.g., uncontrolled blood pressure, pregnancy) that may affect their ability to safely participate will be excluded. Mental incompetency: Individuals who cannot legally consent themselves to the surgical procedure and participation in the research study, will not be considered for inclusion. Patients who have a Deep Brain Stimulation (DBS) system. Patients who have an implanted active cardiac implant (e.g. pacemaker or defibrillator). Patients who have any other implantable neuro-stimulator whose stimulus current pathway may overlap with that of the SPRINT System.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Daniel H Cortes, Ph.D.
    Phone
    814-863-3103
    Email
    dhc13@psu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniel H. Cortes, Ph.D.
    Organizational Affiliation
    Penn State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    PNS vs RFA for Facet Joint Pain

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