PNS vs RFA for Facet Joint Pain

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

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 Overview

• Status: Suspended
• Conditions: Facet Joint Pain
• Intervention / Treatment: Device: Sprint PNS system; Procedure: Radiofrequency Ablation

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peripheral Nerve Stimulation; 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; Temporary electrical stimulation of the medial nerve with implanted wires and wearable stimulator
Active Comparator: Radiofrequency Ablation; 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; Thermal ablation of the medial nerve

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Penn State University
• Investigators: Principal Investigator: Daniel H. Cortes, Ph.D., Penn State University

Study record dates

Study Major Dates

• Study Start (Estimated): February 20, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Therapeutics; Surgical Procedures, Operative; Ablation Techniques; Radiofrequency Therapy; Radiofrequency Ablation
• Other Study ID Numbers: STUDY00022997

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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