SuspendedNCT05952518Updated Feb 10, 2026

PNS vs RFA for Facet Joint Pain

An interventional study of Sprint PNS system and Radiofrequency Ablation in Facet Joint Pain, sponsored by Penn State University. Suspended at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-10.

Sponsored by Penn State University · Not applicable, Interventional, and Treatment

Why this study was suspended

No participants have been enrolled to date. The study is currently under consideration for early termination due to recruitment challenges.

Phase: Not applicable
Study type: Interventional
Enrollment: 70
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Conditions studied

Facet Joint Pain

In context

Lead sponsor

Penn State University is the lead sponsor of 263 studies on the registry; 51 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 70 participants (estimated)

Study arms

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
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

Interventions

DeviceSprint PNS system
Temporary electrical stimulation of the medial nerve with implanted wires and wearable stimulator
ProcedureRadiofrequency Ablation
Thermal ablation of the medial nerve

What researchers measure

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
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
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
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: 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
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
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: 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

Study locations

1 site

Hershey Medical Center
Hershey, Pennsylvania 17033, United States

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05952518
Lead sponsor: Penn State University
Responsible party: Daniel Cortes (Associate Professor, Penn State University) — Principal investigator
First posted: Jul 19, 2023
Start date: Feb 20, 2026 (estimated)
Primary completion: Oct 2026 (estimated)
Completion: Oct 2027 (estimated)
Last update: Feb 10, 2026

Study contacts

Daniel H. Cortes, Ph.D.

principal investigator · Penn State University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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