PNS vs RFA for Facet Joint Pain

NCT ID: NCT05952518

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-20
• Study Completion Date: 2027-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sprint PNS system

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Radiofrequency Ablation

Intervention Type: PROCEDURE

Thermal ablation of the medial nerve

Interventions

Sprint PNS system

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

Intervention Type: DEVICE

Radiofrequency Ablation

Thermal ablation of the medial nerve

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Daniel Cortes

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel H. Cortes, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Daniel H Cortes, Ph.D.

Role: CONTACT

dhc13@psu.edu

814-863-3103

Facility Contacts

Daniel Cortes, PhD

Role: primary

dhc13@psu.edu

814-863-3103

Ruth Jarbadan

Role: backup

njarbadan@pennstatehealth.psu.edu

717-531-6135

Other Identifiers

STUDY00022997

Identifier Type: -

Identifier Source: org_study_id