PNS vs RFA for Facet Joint Pain

February 6, 2026 updated by: Daniel Cortes, Penn State University

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

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Daniel H Cortes, Ph.D.
  • Phone Number: 814-863-3103
  • Email: dhc13@psu.edu

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Multifidus muscle activity
Time Frame: pre-treatment
Muscle contraction quantification via shear wave elastography
pre-treatment
Multifidus muscle activity
Time Frame: within two weeks of treatment completion
Muscle contraction quantification via shear wave elastography
within two weeks of treatment completion
Multifidus muscle activity
Time Frame: 12 months after pre-treatment measurement
Muscle contraction quantification via shear wave elastography
12 months after pre-treatment measurement

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: pre-treatment
Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain.
pre-treatment
Pain Intensity
Time Frame: within two weeks of treatment completion
Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain.
within two weeks of treatment completion
Pain Intensity
Time Frame: 12 months after pre-treatment measurement
Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain.
12 months after pre-treatment measurement
Oswestry Disability Index
Time Frame: pre-treatment
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
Time Frame: within two weeks of treatment completion
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
Time Frame: 12 months after pre-treatment measurement
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
Time Frame: pre-treatment
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
Time Frame: within two weeks of treatment completion
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
Time Frame: 12 months after pre-treatment measurement
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
Time Frame: pre-treatment
Measurement of peak force generated by the torso in extension in Newtons
pre-treatment
Isometric back strength
Time Frame: within two weeks of treatment completion
Measurement of peak force generated by the torso in extension in Newtons
within two weeks of treatment completion
isometric back strength
Time Frame: 12 months after pre-treatment measurement
Measurement of peak force generated by the torso in extension in Newtons
12 months after pre-treatment measurement
Functional Reach
Time Frame: pre-treatment
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
Time Frame: within two weeks of treatment completion
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
Time Frame: 12 months after pre-treatment measurement
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 Frame: pre-treatment
Time to complete 20 rotations, seconds, longer times are worse performance.
pre-treatment
Repetitive Trunk Rotation
Time Frame: within two weeks of treatment completion
Time to complete 20 rotations, seconds, longer times are worse performance.
within two weeks of treatment completion
Repetitive Trunk Rotation
Time Frame: 12 months after pre-treatment measurement
Time to complete 20 rotations, seconds, longer times are worse performance.
12 months after pre-treatment measurement
Repeated Chair Stands
Time Frame: pre-treatment
Time to perform 5 repeated chair stands, higher times mean worse outcomes.
pre-treatment
Repeated Chair Stands
Time Frame: within two weeks of treatment completion
Time to perform 5 repeated chair stands, higher times mean worse outcomes.
within two weeks of treatment completion
Repeated Chair Stands
Time Frame: 12 months after pre-treatment measurement
Time to perform 5 repeated chair stands, higher times mean worse outcomes.
12 months after pre-treatment measurement
Pfirmmann grade
Time Frame: pre-treatment
Degeneration of lumbar discs at the treated level, grade 1 - 5, 1 is normal and 5 is completely collapsed disc.
pre-treatment
Pfirmmann grade
Time Frame: within two weeks of treatment completion
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
Time Frame: 12 months after pre-treatment measurement
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
Time Frame: pre-treatment
T2 relaxation time of the disc at the treated level. Lower values indicate more degeneration.
pre-treatment
t2-relaxation time
Time Frame: within two weeks of treatment completion
T2 relaxation time of the disc at the treated level. Lower values indicate more degeneration.
within two weeks of treatment completion
t2-relaxation time
Time Frame: 12 months after pre-treatment measurement
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
Time Frame: pre-treatment
Intramuscular fat percentage, higher percentage means worse outcome.
pre-treatment
2-point dixon MRI
Time Frame: within two weeks of treatment completion
Intramuscular fat percentage, higher percentage means worse outcome.
within two weeks of treatment completion
2-point dixon MRI
Time Frame: 12 months after pre-treatment measurement
Intramuscular fat percentage, higher percentage means worse outcome.
12 months after pre-treatment measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penn State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel H. Cortes, Ph.D., Penn State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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