PNS vs RFA for Facet Joint Pain (NCT05952518) | Clinical Trial Compass
SuspendedNot Applicable
PNS vs RFA for Facet Joint Pain
Stopped: No participants have been enrolled to date. The study is currently under consideration for early termination due to recruitment challenges.
United States70 participantsStarted 2026-02-20
Plain-language 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.
Who can participate
Age range18 Years ā 80 Years
SexALL
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Inclusion criteria
ā. 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.
ā. 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.
ā. 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.
ā. 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
ā. Previous Spinal Conditions Surgery: We will exclude patients with other spinal conditions like scoliosis or who have received previous spinal surgeries.
ā. 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.
What they're measuring
1
Multifidus muscle activity
Timeframe: pre-treatment
2
Multifidus muscle activity
Timeframe: within two weeks of treatment completion
3
Multifidus muscle activity
Timeframe: 12 months after pre-treatment measurement
ā. 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.
ā. 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.
ā. 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.
ā. Mental incompetency: Individuals who cannot legally consent themselves to the surgical procedure and participation in the research study, will not be considered for inclusion.
ā. Patients who have a Deep Brain Stimulation (DBS) system.
ā. Patients who have an implanted active cardiac implant (e.g. pacemaker or defibrillator).