Clinical trial NCT05952518: PNS Vs RFA for Facet Joint Pain
Official title: Evaluation of Peripheral Nerve Stimulation As an Alternative to Radiofrequency Ablation for Facet Joint Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Facet Joint Pain
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Multifidus muscle activity
timeFrame: pre-treatment
measure: Multifidus muscle activity
timeFrame: within two weeks of treatment completion
measure: Multifidus muscle activity
timeFrame: 12 months after pre-treatment measurement
Secondary outcomes:
measure: Pain Intensity
timeFrame: pre-treatment
measure: Pain Intensity
timeFrame: within two weeks of treatment completion
measure: Pain Intensity
timeFrame: 12 months after pre-treatment measurement
measure: Oswestry Disability Index
timeFrame: pre-treatment
measure: Oswestry Disability Index
timeFrame: within two weeks of treatment completion
measure: Oswestry Disability Index
timeFrame: 12 months after pre-treatment measurement
measure: PROMIS-29 v2.0
timeFrame: pre-treatment
measure: PROMIS-29 v2.0
timeFrame: within two weeks of treatment completion
measure: PROMIS-29 v2.0
timeFrame: 12 months after pre-treatment measurement
measure: isometric back strength
timeFrame: pre-treatment
measure: Isometric back strength
timeFrame: within two weeks of treatment completion
measure: isometric back strength
timeFrame: 12 months after pre-treatment measurement
measure: Functional Reach
timeFrame: pre-treatment
measure: Functional Reach
timeFrame: within two weeks of treatment completion
measure: Functional Reach
timeFrame: 12 months after pre-treatment measurement
measure: Repetitive Trunk Rotation
timeFrame: pre-treatment
measure: Repetitive Trunk Rotation
timeFrame: within two weeks of treatment completion
measure: Repetitive Trunk Rotation
timeFrame: 12 months after pre-treatment measurement
measure: Repeated Chair Stands
timeFrame: pre-treatment
measure: Repeated Chair Stands
timeFrame: within two weeks of treatment completion
measure: Repeated Chair Stands
timeFrame: 12 months after pre-treatment measurement
measure: Pfirmmann grade
timeFrame: pre-treatment
measure: Pfirmmann grade
timeFrame: within two weeks of treatment completion
measure: Pfirmmann grade
timeFrame: 12 months after pre-treatment measurement
measure: t2-relaxation time
timeFrame: pre-treatment
measure: t2-relaxation time
timeFrame: within two weeks of treatment completion
measure: t2-relaxation time
timeFrame: 12 months after pre-treatment measurement
measure: 2-point dixon MRI
timeFrame: pre-treatment
measure: 2-point dixon MRI
timeFrame: within two weeks of treatment completion
measure: 2-point dixon MRI
timeFrame: 12 months after pre-treatment measurement
Other outcomes:
Locations:
Study officials:
affiliation: Penn State University
name: Daniel H. Cortes, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: