PNS vs RFA for Facet Joint Pain

NCT05952518 | Suspended FDA Device

• 1 other identifier: STUDY00022997
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Facet Joint Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (30)

• Pain Intensity

  pre-treatment

• Pain Intensity

  within two weeks of treatment completion

• Pain Intensity

  12 months after pre-treatment measurement

• Oswestry Disability Index

  pre-treatment

• Oswestry Disability Index

  within two weeks of treatment completion

Study Arms (2)

Peripheral Nerve Stimulation

EXPERIMENTAL

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

Radiofrequency Ablation

ACTIVE COMPARATOR

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

Sprint PNS system DEVICE

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

Peripheral Nerve Stimulation

Radiofrequency Ablation PROCEDURE

Thermal ablation of the medial nerve

Radiofrequency Ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Daniel H. Cortes, Ph.D.

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 19, 2023
• Study Start: February 20, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)