PNS vs RFA for Facet Joint Pain

Facet Joint Pain Clinical Trial

Official title:

Evaluation of Peripheral Nerve Stimulation as an Alternative to Radiofrequency Ablation for Facet Joint Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05952518
• Other study ID #: STUDY00022997
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: October 2027

Study information

• Verified date: July 2023
• Source: Penn State University
• Contact: Daniel H Cortes, Ph.D.
• Phone: 814-863-3103
• Email: dhc13[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: October 2027
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthralgia
• Facet Joint Pain

Intervention

Device:
• Sprint PNS system
Temporary electrical stimulation of the medial nerve with implanted wires and wearable stimulator

Procedure:
• Radiofrequency Ablation
Thermal ablation of the medial nerve

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multifidus muscle activity	Muscle contraction quantification via shear wave elastography	pre-treatment
Primary	Multifidus muscle activity	Muscle contraction quantification via shear wave elastography	within two weeks of treatment completion
Primary	Multifidus muscle activity	Muscle contraction quantification via shear wave elastography	12 months after pre-treatment measurement
Secondary	Pain Intensity	Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain.	pre-treatment
Secondary	Pain Intensity	Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain.	within two weeks of treatment completion
Secondary	Pain Intensity	Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain.	12 months after pre-treatment measurement
Secondary	Oswestry Disability Index	Survey evaluating disability level, 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled	pre-treatment
Secondary	Oswestry Disability Index	Survey evaluating disability level, 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled	within two weeks of treatment completion
Secondary	Oswestry Disability Index	Survey evaluating disability level, 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled	12 months after pre-treatment measurement
Secondary	PROMIS-29 v2.0	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)	pre-treatment
Secondary	PROMIS-29 v2.0	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)	within two weeks of treatment completion
Secondary	PROMIS-29 v2.0	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)	12 months after pre-treatment measurement
Secondary	isometric back strength	Measurement of peak force generated by the torso in extension in Newtons	pre-treatment
Secondary	Isometric back strength	Measurement of peak force generated by the torso in extension in Newtons	within two weeks of treatment completion
Secondary	isometric back strength	Measurement of peak force generated by the torso in extension in Newtons	12 months after pre-treatment measurement
Secondary	Functional Reach	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.	pre-treatment
Secondary	Functional Reach	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.	within two weeks of treatment completion
Secondary	Functional Reach	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.	12 months after pre-treatment measurement
Secondary	Repetitive Trunk Rotation	Time to complete 20 rotations, seconds, longer times are worse performance.	pre-treatment
Secondary	Repetitive Trunk Rotation	Time to complete 20 rotations, seconds, longer times are worse performance.	within two weeks of treatment completion
Secondary	Repetitive Trunk Rotation	Time to complete 20 rotations, seconds, longer times are worse performance.	12 months after pre-treatment measurement
Secondary	Repeated Chair Stands	Time to perform 5 repeated chair stands, higher times mean worse outcomes.	pre-treatment
Secondary	Repeated Chair Stands	Time to perform 5 repeated chair stands, higher times mean worse outcomes.	within two weeks of treatment completion
Secondary	Repeated Chair Stands	Time to perform 5 repeated chair stands, higher times mean worse outcomes.	12 months after pre-treatment measurement
Secondary	Pfirmmann grade	Degeneration of lumbar discs at the treated level, grade 1 - 5, 1 is normal and 5 is completely collapsed disc.	pre-treatment
Secondary	Pfirmmann grade	Degeneration of lumbar discs at the treated level, grade 1 - 5, 1 is normal and 5 is completely collapsed disc.	within two weeks of treatment completion
Secondary	Pfirmmann grade	Degeneration of lumbar discs at the treated level, grade 1 - 5, 1 is normal and 5 is completely collapsed disc.	12 months after pre-treatment measurement
Secondary	t2-relaxation time	T2 relaxation time of the disc at the treated level. Lower values indicate more degeneration.	pre-treatment
Secondary	t2-relaxation time	T2 relaxation time of the disc at the treated level. Lower values indicate more degeneration.	within two weeks of treatment completion
Secondary	t2-relaxation time	T2 relaxation time of the disc at the treated level. Lower values indicate more degeneration.	12 months after pre-treatment measurement
Secondary	2-point dixon MRI	Intramuscular fat percentage, higher percentage means worse outcome.	pre-treatment
Secondary	2-point dixon MRI	Intramuscular fat percentage, higher percentage means worse outcome.	within two weeks of treatment completion
Secondary	2-point dixon MRI	Intramuscular fat percentage, higher percentage means worse outcome.	12 months after pre-treatment measurement