PNS vs RFA for Facet Joint Pain

Penn State University70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Facet Joint Pain

Interventions

Sprint PNS systemDEVICE

Temporary electrical stimulation of the medial nerve with implanted wires and wearable stimulator

Radiofrequency AblationPROCEDURE

Thermal ablation of the medial nerve

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. 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. 3. 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. 4. 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: 1. Previous Spinal Conditions Surgery: We will exclude patients with other spinal conditions like scoliosis or who have received previous spinal surgeries. 2. 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. 3. 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. 4. 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. 5. 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. 6. Mental incompetency: Individuals who cannot legally consent themselves to the surgical procedure and participation in the research study, will not be considered for inclusion. 7. Patients who have a Deep Brain Stimulation (DBS) system. 8. Patients who have an implanted active cardiac implant (e.g. pacemaker or defibrillator). 9. Patients who have any other implantable neuro-stimulator whose stimulus current pathway may overlap with that of the SPRINT System.

Locations (1)

Hershey Medical Center

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

Multifidus muscle activity

Muscle contraction quantification via shear wave elastography

Time frame: pre-treatment

Multifidus muscle activity

Muscle contraction quantification via shear wave elastography

Time frame: within two weeks of treatment completion

Multifidus muscle activity

Muscle contraction quantification via shear wave elastography

Time frame: 12 months after pre-treatment measurement

Secondary Outcomes

Pain Intensity

Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain.

Time frame: pre-treatment

Pain Intensity

Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain.

Time frame: within two weeks of treatment completion

Pain Intensity

Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain.

Time frame: 12 months after pre-treatment measurement

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

Time frame: pre-treatment

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

Data from ClinicalTrials.gov

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Time frame: within two weeks of treatment completion

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

Time frame: 12 months after pre-treatment measurement

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)

Time frame: pre-treatment

PROMIS-29 v2.0

Time frame: within two weeks of treatment completion

PROMIS-29 v2.0

Time frame: 12 months after pre-treatment measurement

isometric back strength

Measurement of peak force generated by the torso in extension in Newtons

Time frame: pre-treatment

Isometric back strength

Measurement of peak force generated by the torso in extension in Newtons

Time frame: within two weeks of treatment completion

isometric back strength

Measurement of peak force generated by the torso in extension in Newtons

Time frame: 12 months after pre-treatment measurement

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.

Time frame: pre-treatment

Functional Reach

Time frame: within two weeks of treatment completion

Functional Reach

Time frame: 12 months after pre-treatment measurement

Repetitive Trunk Rotation

Time to complete 20 rotations, seconds, longer times are worse performance.

Time frame: pre-treatment

Repetitive Trunk Rotation

Time to complete 20 rotations, seconds, longer times are worse performance.

Time frame: within two weeks of treatment completion

Repetitive Trunk Rotation

Time to complete 20 rotations, seconds, longer times are worse performance.

Time frame: 12 months after pre-treatment measurement

Repeated Chair Stands

Time to perform 5 repeated chair stands, higher times mean worse outcomes.

Time frame: pre-treatment

Repeated Chair Stands

Time to perform 5 repeated chair stands, higher times mean worse outcomes.

Time frame: within two weeks of treatment completion

Repeated Chair Stands

Time to perform 5 repeated chair stands, higher times mean worse outcomes.

Time frame: 12 months after pre-treatment measurement

Pfirmmann grade

Degeneration of lumbar discs at the treated level, grade 1 - 5, 1 is normal and 5 is completely collapsed disc.

Time frame: pre-treatment

Pfirmmann grade

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

Pfirmmann grade

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

t2-relaxation time

T2 relaxation time of the disc at the treated level. Lower values indicate more degeneration.

Time frame: pre-treatment

t2-relaxation time

T2 relaxation time of the disc at the treated level. Lower values indicate more degeneration.

Time frame: within two weeks of treatment completion

t2-relaxation time

T2 relaxation time of the disc at the treated level. Lower values indicate more degeneration.

Time frame: 12 months after pre-treatment measurement

2-point dixon MRI

Intramuscular fat percentage, higher percentage means worse outcome.

Time frame: pre-treatment

2-point dixon MRI

Intramuscular fat percentage, higher percentage means worse outcome.

Time frame: within two weeks of treatment completion

2-point dixon MRI

Intramuscular fat percentage, higher percentage means worse outcome.

Time frame: 12 months after pre-treatment measurement