Facet Joint PainNCT05952518
PNS vs RFA for Facet Joint Pain
A study testing Sprint PNS system and Radiofrequency Ablation in people with Facet Joint Pain, run by Penn State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Facet Joint Pain
- What is being tested?
- Sprint PNS system and Radiofrequency Ablation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2026to 21 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Peripheral Nerve Stimulation as an Alternative to Radiofrequency Ablation for Facet Joint Pain
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.
- Conditions
- Facet Joint Pain
- Being tested
- Sprint PNS system, Radiofrequency Ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sprint PNS systemDevice
Temporary electrical stimulation of the medial nerve with implanted wires and wearable stimulator
Radiofrequency AblationProcedure or surgery
Thermal ablation of the medial nerve
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multifidus muscle activity
Muscle contraction quantification via shear wave elastography
Measured: pre-treatment
Multifidus muscle activity
Muscle contraction quantification via shear wave elastography
Measured: within two weeks of treatment completion
Multifidus muscle activity
Muscle contraction quantification via shear wave elastography
Measured: 12 months after pre-treatment measurement
Secondary outcomes (30)
Pain Intensity
Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain.
Measured: pre-treatment
Pain Intensity
Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain.
Measured: within two weeks of treatment completion
Pain Intensity
Visual Analog Scale, scale range 1 - 10, 10 being worse possible pain.
Measured: 12 months after pre-treatment measurement
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
Measured: pre-treatment
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
Measured: within two weeks of treatment completion
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
Measured: 12 months after pre-treatment measurement
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)
Measured: pre-treatment
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)
Measured: within two weeks of treatment completion
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)
Measured: 12 months after pre-treatment measurement
isometric back strength
Measurement of peak force generated by the torso in extension in Newtons
Measured: pre-treatment
Isometric back strength
Measurement of peak force generated by the torso in extension in Newtons
Measured: within two weeks of treatment completion
isometric back strength
Measurement of peak force generated by the torso in extension in Newtons
Measured: 12 months after pre-treatment measurement
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.
Measured: pre-treatment
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.
Measured: within two weeks of treatment completion
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.
Measured: 12 months after pre-treatment measurement
Repetitive Trunk Rotation
Time to complete 20 rotations, seconds, longer times are worse performance.
Measured: pre-treatment
Repetitive Trunk Rotation
Time to complete 20 rotations, seconds, longer times are worse performance.
Measured: within two weeks of treatment completion
Repetitive Trunk Rotation
Time to complete 20 rotations, seconds, longer times are worse performance.
Measured: 12 months after pre-treatment measurement
Repeated Chair Stands
Time to perform 5 repeated chair stands, higher times mean worse outcomes.
Measured: pre-treatment
Repeated Chair Stands
Time to perform 5 repeated chair stands, higher times mean worse outcomes.
Measured: within two weeks of treatment completion
Repeated Chair Stands
Time to perform 5 repeated chair stands, higher times mean worse outcomes.
Measured: 12 months after pre-treatment measurement
Pfirmmann grade
Degeneration of lumbar discs at the treated level, grade 1 - 5, 1 is normal and 5 is completely collapsed disc.
Measured: pre-treatment
Pfirmmann grade
Degeneration of lumbar discs at the treated level, grade 1 - 5, 1 is normal and 5 is completely collapsed disc.
Measured: within two weeks of treatment completion
Pfirmmann grade
Degeneration of lumbar discs at the treated level, grade 1 - 5, 1 is normal and 5 is completely collapsed disc.
Measured: 12 months after pre-treatment measurement
t2-relaxation time
T2 relaxation time of the disc at the treated level. Lower values indicate more degeneration.
Measured: pre-treatment
t2-relaxation time
T2 relaxation time of the disc at the treated level. Lower values indicate more degeneration.
Measured: within two weeks of treatment completion
t2-relaxation time
T2 relaxation time of the disc at the treated level. Lower values indicate more degeneration.
Measured: 12 months after pre-treatment measurement
2-point dixon MRI
Intramuscular fat percentage, higher percentage means worse outcome.
Measured: pre-treatment
2-point dixon MRI
Intramuscular fat percentage, higher percentage means worse outcome.
Measured: within two weeks of treatment completion
2-point dixon MRI
Intramuscular fat percentage, higher percentage means worse outcome.
Measured: 12 months after pre-treatment measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start8 Apr 2026
- Primary completion8 Apr 2026
- Study completion21 Apr 2026
Why it stopped: Difficulty recruiting patients. Study is in close out process.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facet Joint PainStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Cortes, Penn State University
- Investigators
- Daniel H. Cortes, Ph.D., Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952518
- Sponsor's protocol ID
- STUDY00022997
- Status last verified
- Oct 2026
- First submitted
- 15 Jun 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Peripheral Nerve Stimulation as an Alternative to Radiofrequency Ablation for Facet Joint Pain
- ClinicalTrials.gov ID
- NCT05952518
- Acronym / sponsor ID
- STUDY00022997
- Conditions
- Facet Joint Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty recruiting patients. Study is in close out process.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 8 Apr 2026 (actual)
- Study completion
- 21 Apr 2026 (actual)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peripheral Nerve Stimulation | Experimental | Device: Sprint PNS systemPeripheral 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. |
| Radiofrequency Ablation | Active comparator | Procedure: Radiofrequency AblationRadiofrequency 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sprint PNS systemTemporary electrical stimulation of the medial nerve with implanted wires and wearable stimulator | Device | Peripheral Nerve Stimulation |
| Radiofrequency AblationThermal ablation of the medial nerve | Procedure or surgery | Radiofrequency Ablation |
Primary outcome
Multifidus muscle activity
Time frame: pre-treatment
Muscle contraction quantification via shear wave elastography
Multifidus muscle activity
Time frame: within two weeks of treatment completion
Muscle contraction quantification via shear wave elastography
Multifidus muscle activity
Time frame: 12 months after pre-treatment measurement
Muscle contraction quantification via shear wave elastography
30 secondary outcomes
Pain Intensity
Time frame: pre-treatment
Pain Intensity
Time frame: within two weeks of treatment completion
Pain Intensity
Time frame: 12 months after pre-treatment measurement
Oswestry Disability Index
Time frame: pre-treatment
Oswestry Disability Index
Time frame: within two weeks of treatment completion
Oswestry Disability Index
Time frame: 12 months after pre-treatment measurement
PROMIS-29 v2.0
Time frame: pre-treatment
PROMIS-29 v2.0
Time frame: within two weeks of treatment completion
PROMIS-29 v2.0
Time frame: 12 months after pre-treatment measurement
isometric back strength
Time frame: pre-treatment
Isometric back strength
Time frame: within two weeks of treatment completion
isometric back strength
Time frame: 12 months after pre-treatment measurement
Functional Reach
Time frame: pre-treatment
Functional Reach
Time frame: within two weeks of treatment completion
Functional Reach
Time frame: 12 months after pre-treatment measurement
Repetitive Trunk Rotation
Time frame: pre-treatment
Repetitive Trunk Rotation
Time frame: within two weeks of treatment completion
Repetitive Trunk Rotation
Time frame: 12 months after pre-treatment measurement
Repeated Chair Stands
Time frame: pre-treatment
Repeated Chair Stands
Time frame: within two weeks of treatment completion
Repeated Chair Stands
Time frame: 12 months after pre-treatment measurement
Pfirmmann grade
Time frame: pre-treatment
Pfirmmann grade
Time frame: within two weeks of treatment completion
Pfirmmann grade
Time frame: 12 months after pre-treatment measurement
t2-relaxation time
Time frame: pre-treatment
t2-relaxation time
Time frame: within two weeks of treatment completion
t2-relaxation time
Time frame: 12 months after pre-treatment measurement
2-point dixon MRI
Time frame: pre-treatment
2-point dixon MRI
Time frame: within two weeks of treatment completion
2-point dixon MRI
Time frame: 12 months after pre-treatment measurement
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Association of Subcutaneous Fat Index, Paraspinal Muscle Characteristics, and Facet Morphology With Lumbar Facet Joint Degeneration
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Trident Multi-tined Cannula for Cervical MBRFA Compared to the Conventional Cannula
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel H. Cortes, Ph.D. principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sprint PNS system and Radiofrequency Ablation in people with Facet Joint Pain, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multifidus muscle activity (time frame: pre-treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.