Low Back PainNCT07433634
Time to BBVNA Relief
An observational study of Low Back Pain and Vertebrogenic Pain Syndrome, run by Yale University at 3 sites in United States.
Trial summary
Basivertebral nerve ablation (BVNA) is a minimally invasive procedure approved for vertebrogenic low back pain. While early studies support its efficacy, real-world evidence is still evolving, particularly regarding the trajectory of pain relief and functional improvement over time, and predictors of clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Vertebrogenic Pain Syndrome, Basivertebral Nerve Ablation
- What is being tested?
- Basivertebral nerve ablation
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Apr 2024to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will compromise all healthy adults presenting to the outpatient orthopedic and rehabilitation clinic with symptoms of vertebrogenic low back pain.
Who may be able to join
- Diagnosis of chronic axial low back pain with vertebrogenic features
- Scheduled for BVN ablation
- Able to provide informed consent
- Capable of participating in weekly virtual/telephone follow-up for 8 weeks and in- person or remote follow-up at 3 and 6 months through 2 years
Who cannot join
- Prior spinal neuromodulation therapy (e.g., spinal cord stimulation or intrathecal pump) within the past 6 months
- Active substance use disorder or uncontrolled psychiatric illness that may interfere with participation
- Cognitive impairment limiting ability to complete surveys or provide informed consent
- Pregnancy
- Incarceration or current status as a prisoner
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Yale Spine and Pain Center - Guilford
Guilford, Connecticut, 06437
- Recruiting
Yale Pain Management Center - New Haven
New Haven, Connecticut, 06519
- Recruiting
Yale Interventional Spine and Musculoskeletal Medicine - Old Saybrook
Old Saybrook, Connecticut, 06475
About this study
Official title: Temporal Trends and Predictors of Clinical Response Following Basivertebral Nerve (BVN) Ablation: A Prospective Observational Cohort Study
Basivertebral nerve ablation (BVNA) is a minimally invasive procedure approved for vertebrogenic low back pain. While early studies support its efficacy, real-world evidence is still evolving, particularly regarding the trajectory of pain relief and functional improvement over time, and predictors of clinical response. This study aims to evaluate clinical outcomes longitudinally following BVNA and identify baseline predictors of response.
Read the detailed description
Primary Objective:
- To determine the proportion of patients achieving clinical response (defined as ≥50% reduction in VAS or ≥15-point improvement in ODI) following BVNA.
Secondary Objectives:
- To assess changes in PROMIS-7, PAVS, and other patient-reported outcomes.
- To determine the incidence of further interventions such as epidural steroid injections (ESIs) or surgeries.
- To evaluate temporal trends in response and adverse events. A total of 11 visits inclusive of follow up visits with schedule for study intervals. 1 baseline visit, 8 virtual/ phone weekly visits, 1 3-month virtual visit , 1 6-month , 1 12-month and 1 24-month visit.
- Being tested
- Basivertebral nerve ablation
- Keywords
- Pain relief trajectory, Basivertebral nerve ablation, Vertebrogenic low back pain,, Responder phenotypes, Clinical Outcomes, Radiofrequency Ablation
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basivertebral nerve ablationProcedure or surgery
Also called Basivertebral Nerve Radiofrequency Ablation
Participants underwent fluoroscopically guided intraosseous basivertebral nerve ablation (BVNA) using the Intracept® System (Boston Scientific, MA, USA) targeting MRI-confirmed Modic type 1 or 2 vertebral endplate changes. Procedures were performed under general anesthesia via a transpedicular or parapedicular approach with biplanar fluoroscopic confirmation of probe placement at the basivertebral foramen (30-50% vertebral body depth, midline AP position). Thermal radiofrequency ablation was delivered using either 75°C for 7 minutes (targeted lesion) or 85°C for 15 minutes (expanded lesion), selected based on intraoperative probe proximity to the intended target to optimize nerve capture. Only levels with imaging-confirmed Modic changes were treated. Weekly patient-reported outcomes were collected for 8, 12, 24 , 48 through 98 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants achieving clinical response
Clinical response defined as a ≥50% reduction in pain intensity from baseline as measured by the Visual Analog Scale (VAS) or a ≥15-point improvement in the Oswestry Disability Index (ODI) score
Measured: 2 years
Secondary outcomes (4)
Change in PROMIS-7 Global Health Score
7-item, self-report, or parent-proxy tool designed to assess overall physical, mental, and social health using a 5-point Likert scale., score range 20-80. It generates a T-score, where 50 is the U.S. population average and 10 is the standard deviation. Higher scores indicate better overall health.
Measured: 2 years
Percentage of participants with incresed physical activity assessed using Physical Activity Vital Sign (PAVS)
2-question screening tool used in clinical settings to assess if adults meet the recommended 150+ minutes of weekly moderate-to-vigorous physical activity. Calculate the total weekly minutes of exercise by multiplying #1 times #2.
Measured: 2 years
Incidence of spine-related interventions
Incidence of further spine-related interventions (e.g., epidural steroid injections, radiofrequency ablation, or spine surgery) post-BVN ablation.
Measured: 2 years
Patient Global Impression of Change (PGIC) score
Self-report 7-point scale measuring a patient's belief regarding the effectiveness of a treatment with higher scores indicating a better outcome. Score range 1-7.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start19 Apr 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Yale 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles A Odonkor, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433634
- Sponsor's protocol ID
- 2000040858
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Trends and Predictors of Clinical Response Following Basivertebral Nerve (BVN) Ablation: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07433634
- Acronym / sponsor ID
- 2000040858
- Keywords
- Pain relief trajectory, Basivertebral nerve ablation, Vertebrogenic low back pain,, Responder phenotypes, Clinical Outcomes, Radiofrequency Ablation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 25 Feb 2026 (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.
Basivertebral nerve ablation (BVNA) is a minimally invasive procedure approved for vertebrogenic low back pain. While early studies support its efficacy, real-world evidence is still evolving, particularly regarding the trajectory of pain relief and functional improvement over time, and predictors of clinical response. This study aims to evaluate clinical outcomes longitudinally following BVNA and identify baseline predictors of response.
Detailed description
Primary Objective:
- To determine the proportion of patients achieving clinical response (defined as ≥50% reduction in VAS or ≥15-point improvement in ODI) following BVNA.
Secondary Objectives:
- To assess changes in PROMIS-7, PAVS, and other patient-reported outcomes.
- To determine the incidence of further interventions such as epidural steroid injections (ESIs) or surgeries.
- To evaluate temporal trends in response and adverse events. A total of 11 visits inclusive of follow up visits with schedule for study intervals. 1 baseline visit, 8 virtual/ phone weekly visits, 1 3-month virtual visit , 1 6-month , 1 12-month and 1 24-month visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will compromise all healthy adults presenting to the outpatient orthopedic and rehabilitation clinic with symptoms of vertebrogenic low back pain.
Key inclusion criteria (4 listed)
- Diagnosis of chronic axial low back pain with vertebrogenic features
- Scheduled for BVN ablation
- Able to provide informed consent
- Capable of participating in weekly virtual/telephone follow-up for 8 weeks and in- person or remote follow-up at 3 and 6 months through 2 years
Key exclusion criteria (5 listed)
- Prior spinal neuromodulation therapy (e.g., spinal cord stimulation or intrathecal pump) within the past 6 months
- Active substance use disorder or uncontrolled psychiatric illness that may interfere with participation
- Cognitive impairment limiting ability to complete surveys or provide informed consent
- Pregnancy
- Incarceration or current status as a prisoner
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 |
|---|---|---|
| Basivertebral nerve ablationAlso: Basivertebral Nerve Radiofrequency AblationParticipants underwent fluoroscopically guided intraosseous basivertebral nerve ablation (BVNA) using the Intracept® System (Boston Scientific, MA, USA) targeting MRI-confirmed Modic type 1 or 2 vertebral endplate changes. Procedures were performed under general anesthesia via a transpedicular or parapedicular approach with biplanar fluoroscopic confirmation of probe placement at the basivertebral foramen (30-50% vertebral body depth, midline AP position). Thermal radiofrequency ablation was delivered using either 75°C for 7 minutes (targeted lesion) or 85°C for 15 minutes (expanded lesion), selected based on intraoperative probe proximity to the intended target to optimize nerve capture. Only levels with imaging-confirmed Modic changes were treated. Weekly patient-reported outcomes were collected for 8, 12, 24 , 48 through 98 weeks. | Procedure or surgery | – |
Primary outcome
Percentage of participants achieving clinical response
Time frame: 2 years
Clinical response defined as a ≥50% reduction in pain intensity from baseline as measured by the Visual Analog Scale (VAS) or a ≥15-point improvement in the Oswestry Disability Index (ODI) score
4 secondary outcomes
Change in PROMIS-7 Global Health Score
Time frame: 2 years
Percentage of participants with incresed physical activity assessed using Physical Activity Vital Sign (PAVS)
Time frame: 2 years
Incidence of spine-related interventions
Time frame: 2 years
Patient Global Impression of Change (PGIC) score
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Charles A Odonkor, MD principal investigator
Yale University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Vertebrogenic Pain Syndrome, run by Yale University at 3 sites 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 5 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: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles A Odonkor, MD (203-767-1555, kcodonkor@aya.yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants achieving clinical response (time frame: 2 years). 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 3 Mar 2026.