PNS vs RFA for Facet Joint Pain | NCT05952518

NCT05952518

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Sprint PNS system	Device	Temporary electrical stimulation of the medial nerve with implanted wires and wearable stimulator	Peripheral Nerve Stimulation

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Eligibility Module

Eligibility Criteria

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:

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.

ID	Term
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative