PNS vs RFA for Facet Joint Pain

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Peripheral Nerve Stimulation as an Alternative to Radiofrequency Ablation for Facet Joint Pain

Conditions
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Facet Joint Pain

Intervention / Treatment
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* Device: Sprint PNS system
* Procedure: Radiofrequency Ablation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peripheral Nerve Stimulation<br>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. | Device: Sprint PNS system<br>* Temporary electrical stimulation of the medial nerve with implanted wires and wearable stimulator<br>|
| Active Comparator: Radiofrequency Ablation<br>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. | Procedure: Radiofrequency Ablation<br>* Thermal ablation of the medial nerve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multifidus muscle activity | Muscle contraction quantification via shear wave elastography | pre-treatment | 
| Multifidus muscle activity | Muscle contraction quantification via shear wave elastography | within two weeks of treatment completion | 
| Multifidus muscle activity | Muscle contraction quantification via shear wave elastography | 12 months after pre-treatment measurement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain. | pre-treatment | 
| Pain Intensity | Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain. | within two weeks of treatment completion | 
| Pain Intensity | Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain. | 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 | 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 | 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 | 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) | pre-treatment | 
| 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) | within two weeks of treatment completion | 
| 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) | 12 months after pre-treatment measurement | 
| isometric back strength | Measurement of peak force generated by the torso in extension in Newtons | pre-treatment | 
| Isometric back strength | Measurement of peak force generated by the torso in extension in Newtons | within two weeks of treatment completion | 
| isometric back strength | Measurement of peak force generated by the torso in extension in Newtons | 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. | pre-treatment | 
| 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. | within two weeks of treatment completion | 
| 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. | 12 months after pre-treatment measurement | 
| Repetitive Trunk Rotation | Time to complete 20 rotations, seconds, longer times are worse performance. | pre-treatment | 
| Repetitive Trunk Rotation | Time to complete 20 rotations, seconds, longer times are worse performance. | within two weeks of treatment completion | 
| Repetitive Trunk Rotation | Time to complete 20 rotations, seconds, longer times are worse performance. | 12 months after pre-treatment measurement | 
| Repeated Chair Stands | Time to perform 5 repeated chair stands, higher times mean worse outcomes. | pre-treatment | 
| Repeated Chair Stands | Time to perform 5 repeated chair stands, higher times mean worse outcomes. | within two weeks of treatment completion | 
| Repeated Chair Stands | Time to perform 5 repeated chair stands, higher times mean worse outcomes. | 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. | pre-treatment | 
| Pfirmmann grade | Degeneration of lumbar discs at the treated level, grade 1 - 5, 1 is normal and 5 is completely collapsed disc. | 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. | 12 months after pre-treatment measurement | 
| t2-relaxation time | T2 relaxation time of the disc at the treated level. Lower values indicate more degeneration. | pre-treatment | 
| t2-relaxation time | T2 relaxation time of the disc at the treated level. Lower values indicate more degeneration. | within two weeks of treatment completion | 
| t2-relaxation time | T2 relaxation time of the disc at the treated level. Lower values indicate more degeneration. | 12 months after pre-treatment measurement | 
| 2-point dixon MRI | Intramuscular fat percentage, higher percentage means worse outcome. | pre-treatment | 
| 2-point dixon MRI | Intramuscular fat percentage, higher percentage means worse outcome. | within two weeks of treatment completion | 
| 2-point dixon MRI | Intramuscular fat percentage, higher percentage means worse outcome. | 12 months after pre-treatment measurement |