Facet Joint Pain
Conditions
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.
Interventions
DEVICESprint PNS system
Temporary electrical stimulation of the medial nerve with implanted wires and wearable stimulator
PROCEDURERadiofrequency Ablation
Thermal ablation of the medial nerve
Sponsors
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Multifidus muscle activity | pre-treatment | Muscle contraction quantification via shear wave elastography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | pre-treatment | Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain. |
| Oswestry Disability Index | pre-treatment | Survey evaluating disability level, 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled |
| PROMIS-29 v2.0 | pre-treatment | Survey assessing pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) |
| isometric back strength | pre-treatment | Measurement of peak force generated by the torso in extension in Newtons |
| Isometric back strength | within two weeks of treatment completion | Measurement of peak force generated by the torso in extension in Newtons |
| Functional Reach | pre-treatment | distance between the length of an outstretched arm in a maximal forward reach, 10"/25 cm or greater Low risk of falls, 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal, 6"/15cm or less Risk of falling is 4x greater than normal, Unwilling to reach Risk of falling is 8x greater than normal. |
| Repetitive Trunk Rotation | pre-treatment | Time to complete 20 rotations, seconds, longer times are worse performance. |
| Repeated Chair Stands | pre-treatment | Time to perform 5 repeated chair stands, higher times mean worse outcomes. |
| Pfirmmann grade | pre-treatment | Degeneration of lumbar discs at the treated level, grade 1 - 5, 1 is normal and 5 is completely collapsed disc. |
| t2-relaxation time | pre-treatment | T2 relaxation time of the disc at the treated level. Lower values indicate more degeneration. |
| 2-point dixon MRI | pre-treatment | Intramuscular fat percentage, higher percentage means worse outcome. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel H. Cortes, Ph.D.
Penn State University
Outcome results
None listed