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Basivertebral Nerve Ablation

A minimally invasive, sham-trial-proven treatment for vertebrogenic pain — disables the nerve inside the vertebra itself, no fusion or implant required.

Part 1: Indications and Candidacy

In This Guide

  • What basivertebral nerve ablation treats
  • How vertebrogenic pain differs from other back pain
  • Who is a good candidate
  • Who should not have this procedure
  • How we confirm you are a candidate

What Is Basivertebral Nerve Ablation?

Basivertebral nerve ablation, often called the Intracept Procedure, is a minimally invasive treatment for a specific type of chronic low back pain called vertebrogenic pain. Vertebrogenic pain comes from the vertebral body itself, the block-shaped bone that makes up your spine, rather than from a disc, a joint, or a pinched nerve. This procedure uses heat delivered through a thin instrument to disable the basivertebral nerve, the small nerve inside the vertebra that carries these pain signals to your brain.

The Intracept system received FDA 510(k) clearance based on a rigorous, sham-controlled clinical trial called the SMART trial, led by Dr. Jeffrey Fischgrund and colleagues. This is one of the few interventional spine procedures in interventional spine care with this level of high-quality evidence behind it.

Sources: Fischgrund et al., SMART Trial, European Spine Journal, 2018; FDA 510(k) Clearance K153272.

How Vertebrogenic Pain Is Different

Most chronic low back pain is blamed on discs, facet joints, or nerve compression. Vertebrogenic pain has a different source: the endplate, which is the thin cap of bone and cartilage between the disc and the vertebral body. When the endplate is damaged, it can trigger inflammation and bone marrow changes that show up on MRI as what radiologists call Modic changes. These changes correlate with pain signals carried by the basivertebral nerve.

  • Type 1 Modic change: shows active inflammation and swelling in the bone marrow next to the disc, often the more painful pattern.
  • Type 2 Modic change: shows fatty replacement of bone marrow, a later-stage change that can still be a source of pain.
  • Where it is found: Modic changes relevant to this procedure are typically seen at one or more vertebral endplates between L3 and S1, the lower lumbar spine.

Who Is a Good Candidate?

Candidacy for basivertebral nerve ablation is based on the same criteria used in the SMART trial and confirmed in real-world practice since. In general, you may be a candidate if you have most or all of the following:

  1. Chronic axial low back pain, meaning pain centered in the low back, lasting 6 months or longer.
  2. Pain that has not improved after at least 6 months of conservative (non-surgical) care, such as physical therapy, medication, and activity modification.
  3. MRI evidence of Type 1 or Type 2 Modic changes at one or more vertebral levels between L3 and S1.
  4. Significant functional limitation from the pain, typically reflected in a meaningful Oswestry Disability Index (ODI) score and a Visual Analog Scale (VAS) pain score of at least 4 out of 10.
  5. Skeletal maturity (fully grown spine), confirmed on imaging.
  6. No major alternative explanation for the pain, such as significant nerve compression, instability, or infection, found on history, exam, and imaging.

Sources: Fischgrund et al., SMART Trial inclusion criteria, European Spine Journal, 2018.

In the SMART trial, participants ranged in age from 25 to 69 years, with an average age of 47. Most published series and real-world practice extend candidacy up to roughly age 80, depending on bone quality and overall health, since age itself is not a strict cutoff as long as the diagnostic criteria are met.

Sources: Fischgrund et al., SMART Trial baseline characteristics, European Spine Journal, 2018.

Who Is Not a Candidate

This procedure is designed specifically for vertebrogenic pain. It is not the right treatment if your pain is coming from a different source, or if certain safety concerns are present. You are generally not a candidate if you have any of the following:

  1. Predominant radicular pain, meaning pain that travels down the leg along a nerve path, rather than pain centered in the low back.
  2. Prior spine surgery, including fusion, at the level being considered for treatment.
  3. Symptomatic spinal stenosis with neurogenic claudication, or spinal instability such as spondylolisthesis greater than 2 millimeters.
  4. Active spinal or systemic infection.
  5. Uncontrolled bleeding disorder (coagulopathy) or the inability to safely stop blood-thinning medication.
  6. Pregnancy.
  7. Osteoporosis with a T-score worse than negative 2.5, or another metabolic bone disease that weakens the vertebral body.
  8. A tumor, active malignancy, or spine fracture at the target level.
  9. A pacemaker, defibrillator, or other implanted electronic device, unless specific precautions are taken.
  10. Skeletal immaturity (patients under 18).

Sources: Fischgrund et al., SMART Trial exclusion criteria, European Spine Journal, 2018; CMS LCD L39644, Intraosseous Basivertebral Nerve Ablation.

How We Confirm You Are a Candidate

Before recommending this procedure, Dr. Waldrop and our team complete a careful work-up. This typically includes a detailed history and physical exam to confirm your pain pattern is consistent with vertebrogenic pain, a review of at least 6 months of conservative treatment, and an MRI of the lumbar spine to look specifically for Type 1 or Type 2 Modic changes at the levels causing your symptoms. Unlike some other interventional procedures, basivertebral nerve ablation does not require a diagnostic nerve block before treatment, because the MRI findings themselves, combined with your clinical picture, are used to confirm the diagnosis.

Who Tends to Benefit Most

  • Patients with chronic low back pain lasting 6 months or more that has not responded to conservative care.
  • Patients with clear Type 1 or Type 2 Modic changes on MRI at L3-S1.
  • Patients whose pain is centered in the low back, not radiating down the leg.
  • Patients without prior fusion, active infection, or severe instability at the target level.

Glossary of Medical Terms

TermWhat It Means
Basivertebral nerveA small nerve that runs through the center of each vertebra (spine bone) and carries pain signals from the bone itself.
Vertebrogenic painChronic low back pain that comes from the vertebral body (spine bone) rather than a disc, joint, or nerve root.
Modic changesSpecific patterns seen on an MRI scan at the endplate (the cap of bone next to a disc) that suggest inflammation or bone marrow change linked to vertebrogenic pain.
Type 1 Modic changeAn MRI pattern showing active inflammation and swelling in the vertebral bone marrow next to a disc.
Type 2 Modic changeAn MRI pattern showing fatty replacement of bone marrow, a later-stage change often still linked to pain.
Intracept ProcedureThe brand name for the basivertebral nerve ablation system made by Relievant Medsystems, cleared by the FDA to treat vertebrogenic pain.
Oswestry Disability Index (ODI)A standard questionnaire that scores how much back pain limits daily activities, from 0 (no disability) to 100 (fully disabled).
Visual Analog Scale (VAS)A 0-10 (or 0-cm to 10-cm) scale patients use to rate their pain intensity.
SMART trialThe pivotal FDA clinical study (Fischgrund et al.) that tested basivertebral nerve ablation against a sham (fake) procedure.
Conservative careNon-surgical treatments such as physical therapy, medication, and activity modification tried before considering a procedure.
Axial low back painPain centered in the lower back itself, as opposed to pain that radiates down the leg.
Radicular painPain that travels down the leg along the path of a nerve root, usually from nerve compression, different from vertebrogenic pain.
EndplateThe thin layer of bone and cartilage that caps each end of a vertebral body, next to the disc.
Vertebral bodyThe large, block-shaped part of a spine bone that bears weight and stacks with other vertebrae to form the spine.
SpondylolisthesisA condition in which one vertebra slips forward relative to the one below it.
Spinal stenosisNarrowing of the spinal canal that can pinch the spinal cord or nerve roots.
Discogenic painBack pain thought to arise from a damaged or degenerated disc rather than the vertebral bone.

Sources

This handout is based on the following evidence-based, peer-reviewed, and professional-society sources:

Part 2: Risks and Benefits

In This Guide

  • How well the procedure works
  • Complication and safety data from clinical trials
  • Real-world safety reporting
  • Comparing benefits to risks
  • Warning signs after your procedure

The Benefits: What the Evidence Shows

Basivertebral nerve ablation has one of the strongest evidence bases of any interventional spine procedure, anchored by the SMART trial, a prospective, randomized, double-blind, sham-controlled study of 225 patients led by Dr. Jeffrey Fischgrund. In this design, some patients received the real ablation and others received a sham (fake) procedure, so researchers could isolate the treatment's true effect rather than a placebo response.

Sources: Fischgrund et al., SMART Trial, European Spine Journal, 2018.

At 3 months, patients who received basivertebral nerve ablation improved by a mean of 20.5 points on the Oswestry Disability Index (ODI), compared with 15.2 points in the sham group, a statistically significant difference. By 12 months, pain scores (VAS) were significantly better in the treatment group than the sham group. These improvements were sustained and, in many patients, continued to grow over time.

Sources: Fischgrund et al., SMART Trial 3- and 12-month results, European Spine Journal, 2018.

At 24 months, the treatment group in the SMART trial showed a mean ODI improvement of about 23 to 24 points and a mean VAS pain reduction of about 3.6 points, translating to roughly 53 to 54 percent average improvement in both disability and pain from baseline. About 57 to 58 percent of patients were classified as responders on both pain and function measures at 2 years.

Sources: Fischgrund et al., SMART Trial 2-Year Results, International Journal of Spine Surgery, 2019.

These benefits held up even further out. At an average follow-up of 6.4 years, the treatment arm maintained a mean ODI reduction of about 26 points and a mean VAS reduction of about 4.4 points from baseline, with about 66 percent of patients achieving at least a 50 percent reduction in pain and roughly one-third reporting being completely pain-free.

Sources: Fischgrund et al., SMART Trial Long-Term (5-Year) Results, European Spine Journal, 2020.

  • Reduced healthcare use: a pooled analysis of three prospective trials found large drops in downstream low back pain-related care after basivertebral nerve ablation, including roughly a 74 percent reduction in opioid use and about an 84 percent reduction in other spinal interventions.
  • Low reoperation rate: in a pooled one-year cohort of 247 treated patients, only about 1.6 percent went on to a lumbosacral spine surgery such as fusion, disc replacement, or laminectomy within a year, and some of those were for unrelated pain sources found later.

Sources: Pooled analysis, Low Back Pain-Related Healthcare Utilization Following BVNA, Pain Medicine, 2024.

The Risks: What the Data Show

Basivertebral nerve ablation has a strong safety record across clinical trials and years of real-world use, but like any spine procedure, it is not risk-free. In the pooled safety analysis of 473 clinical trial patients across multiple studies, there was 1 serious device- or procedure-related event, a vertebral compression fracture in a sham-crossover patient who had osteopenia and was on hormone therapy; it healed on its own within 8 weeks. That works out to a serious complication rate of about 0.2 percent.

Sources: ISASS Policy Statement 2022, Systematic Review of Intraosseous Basivertebral Nerve Ablation.

Non-serious, transient events were somewhat more common but still uncommon overall, occurring in about 5.5 percent of the same pooled trial population (26 of 473 procedures). The most frequent were temporary increases in back pain, new leg pain, or radiculitis (nerve irritation), all of which resolved, typically within about 2 months, usually with oral medication alone.

Sources: ISASS Policy Statement 2022; Fischgrund et al., SMART Trial safety data, European Spine Journal, 2018.

A separate review of real-world safety reports submitted to the FDA's MAUDE database (post-market surveillance, reflecting problems reported after the device reached the general market, not necessarily the true incidence rate) identified vertebral compression fracture as the most common serious event reported, most often in older patients (mean age 79) with underlying bone fragility. Because MAUDE captures voluntary reports rather than a fixed denominator of all procedures performed, it cannot be used to calculate a true population complication rate, but it does highlight the importance of screening for osteoporosis and bone health before the procedure.

Sources: Adverse events associated with basivertebral nerve ablation, FDA MAUDE analysis, PMC.

Reported complication types, all rare, include:

  • Vertebral compression fracture, more often in patients with unrecognized osteoporosis or bone fragility.
  • Infection at the needle insertion site (rare; no confirmed post-procedure infections were reported in the pivotal trial population).
  • Nerve root injury or transient nerve irritation (radiculitis), which is typically temporary.
  • Bleeding, including rare reports of retroperitoneal hemorrhage.
  • Expected, mild post-procedural soreness at the incision site, which is common but not considered a complication.

Sources: StatPearls, Basivertebral Nerve Ablation, NCBI Bookshelf.

Weighing Benefits Against Risks

For patients who meet the specific criteria for vertebrogenic pain, the evidence supports a favorable balance: durable pain and function improvement in roughly two-thirds of patients out to 5 years, a very low rate of serious complications, and a much lower reoperation rate than many patients expect. Dr. Waldrop will review your personal risk factors, especially bone health, before recommending this procedure.

Seek Prompt Medical Attention If You Notice

  • Sudden, severe back pain that is different or worse than your usual pain, especially if it comes on suddenly days to weeks after the procedure (possible fracture).
  • New numbness, tingling, or weakness in your legs.
  • Fever, chills, or redness, warmth, or drainage at the incision site (possible infection).
  • New loss of bladder or bowel control (seek emergency care immediately).
  • Significant swelling, bruising, or a firm, painful mass near the injection site.

Glossary of Medical Terms

TermWhat It Means
Basivertebral nerveA small nerve that runs through the center of each vertebra (spine bone) and carries pain signals from the bone itself.
Vertebrogenic painChronic low back pain that comes from the vertebral body (spine bone) rather than a disc, joint, or nerve root.
Radiofrequency ablation (RFA)A technique that uses heat generated by radio waves to disable a nerve's ability to send pain signals.
Oswestry Disability Index (ODI)A standard questionnaire that scores how much back pain limits daily activities, from 0 (no disability) to 100 (fully disabled).
Visual Analog Scale (VAS)A 0-10 (or 0-cm to 10-cm) scale patients use to rate their pain intensity.
SMART trialThe pivotal FDA clinical study (Fischgrund et al.) that tested basivertebral nerve ablation against a sham (fake) procedure.
Sham-controlled trialA study design where some patients receive a fake version of the treatment so researchers can measure the treatment's true effect.
ResponderIn clinical trials, a patient whose pain or disability score improved by a defined amount, such as 50 percent.
Vertebral bodyThe large, block-shaped part of a spine bone that bears weight and stacks with other vertebrae to form the spine.
EndplateThe thin layer of bone and cartilage that caps each end of a vertebral body, next to the disc.
Conscious sedationA light sleep-like state produced by medication that keeps a patient relaxed and comfortable but breathing on their own during a procedure.
Outpatient procedureA procedure that does not require an overnight hospital stay; patients go home the same day.

Sources

This handout is based on the following evidence-based, peer-reviewed, and professional-society sources:

Part 3: How the Procedure Is Performed

In This Guide

  • Before your procedure
  • Positioning and anesthesia
  • Step-by-step technique
  • How long it takes
  • What you can expect to feel

Before Your Procedure

Basivertebral nerve ablation is performed as an outpatient procedure, meaning you go home the same day. You will typically be asked to stop blood-thinning medications ahead of time if it is safe to do so, arrange for a ride home, and avoid eating or drinking for a set period beforehand, similar to other sedation procedures. Our team will give you specific instructions tailored to your health history.

Positioning and Anesthesia

You will lie face down (prone) on a procedure table, usually with padding to gently arch your lower back into a position that makes the target vertebrae easier to reach. Most patients receive conscious sedation, a light, relaxed, sleep-like state combined with numbing medication at the skin, so you are comfortable but breathing on your own throughout. Some practices use general anesthesia instead, depending on patient preference and health factors; in the SMART trial, sedation approaches were split roughly evenly between general anesthesia and moderate conscious sedation.

Sources: Fischgrund et al., SMART Trial methods, European Spine Journal, 2018.

Step-by-Step: How the Ablation Is Done

The goal of the procedure is to reach the basivertebral nerve, which runs through the center of the vertebral body toward its back wall, and disable it with heat. This is done from inside the bone, not from outside the spine, which is why it is called an intraosseous (inside the bone) or transpedicular (through the pedicle) technique.

  1. The skin over the target vertebra is cleaned and numbed with local anesthetic; antibiotics are often given intravenously to reduce infection risk.
  2. Using continuous fluoroscopy (live X-ray imaging) for guidance, a thin introducer needle is advanced through the pedicle, the bony bridge on the back of the vertebra, into the vertebral body.
  3. A curved, steerable instrument (sometimes called a J-stylet or articulating probe) is passed through the introducer and guided to the target point: the junction of the posterior-central third of the vertebral body, where the basivertebral nerve runs.
  4. Once positioning is confirmed on multiple X-ray views, a radiofrequency probe is inserted through the access channel.
  5. The probe delivers radiofrequency energy, heating the tissue at the nerve to about 85 degrees Celsius for approximately 15 minutes, which disables the nerve's ability to carry pain signals.
  6. The instruments are removed, manual pressure is applied for several minutes to control any bleeding, and a small bandage or skin adhesive is placed over the entry site.
  7. If more than one level is being treated (commonly at levels between L3 and S1), the same steps are repeated at each additional level through separate small skin punctures.

Sources: Vertebrogenic Low Back Pain and Basivertebral Nerve Ablation, technique description, PMC.

How Long It Takes

The procedure itself generally takes about 60 to 90 minutes, depending on how many vertebral levels are being treated; the active heating (ablation) portion of each level takes roughly 7 to 15 minutes. After the procedure, you will spend a short time in a recovery area while your sedation wears off before being discharged home.

Sources: Cleveland Clinic, Intracept Procedure.

What Happens Immediately Afterward

Because this is a same-day, outpatient procedure, you will not stay overnight. Someone must drive you home, since you will not be able to drive yourself after sedation. Most patients are encouraged to rest for the remainder of the day and gradually resume light activity as tolerated over the following days.

What You Can Expect to Feel

  • Mild to moderate soreness at the small skin incision(s) and in the low back for a few days, similar to a muscle strain.
  • Little to no pain during the procedure itself, since sedation and local anesthetic keep you comfortable.
  • Some patients feel groggy or tired for the rest of the day from the sedation, which wears off within hours.
  • It is normal not to feel dramatic pain relief immediately; meaningful improvement typically builds over the following weeks to months as the nerve fully stops signaling pain.
  • Bruising or minor swelling at the injection site can occur and usually resolves within a week or two.

Glossary of Medical Terms

TermWhat It Means
Basivertebral nerveA small nerve that runs through the center of each vertebra (spine bone) and carries pain signals from the bone itself.
Radiofrequency ablation (RFA)A technique that uses heat generated by radio waves to disable a nerve's ability to send pain signals.
Transpedicular approachA technique for reaching the inside of a vertebra by passing a instrument through the pedicle, the bony bridge on the back of the spine bone.
CannulaA thin, hollow tube used to create a path into the bone for the ablation instrument.
FluoroscopyA type of real-time X-ray imaging used to guide instruments precisely during the procedure.
Conscious sedationA light sleep-like state produced by medication that keeps a patient relaxed and comfortable but breathing on their own during a procedure.
Outpatient procedureA procedure that does not require an overnight hospital stay; patients go home the same day.
Vertebral bodyThe large, block-shaped part of a spine bone that bears weight and stacks with other vertebrae to form the spine.
EndplateThe thin layer of bone and cartilage that caps each end of a vertebral body, next to the disc.
Intracept ProcedureThe brand name for the basivertebral nerve ablation system made by Relievant Medsystems, cleared by the FDA to treat vertebrogenic pain.
Vertebrogenic painChronic low back pain that comes from the vertebral body (spine bone) rather than a disc, joint, or nerve root.

Sources

This handout is based on the following evidence-based, peer-reviewed, and professional-society sources:

Part 4: Recovery Roadmap

In This Guide

  • Day of the procedure
  • The first week
  • Weeks 2 through 6
  • When to expect pain relief
  • Warning signs during recovery

Day of the Procedure

Basivertebral nerve ablation is done as an outpatient procedure, so you go home the same day after a short monitoring period in the recovery area once your sedation wears off. You will need someone to drive you home, and you should not drive or operate machinery for the rest of the day, or for as long as you are taking sedating pain medication. Icing the treated area for about 20 minutes at a time can help with soreness.

Sources: Cleveland Clinic, Intracept Procedure.

The First Week

Most practices recommend avoiding strenuous exercise for about 48 hours, and keeping activity light for several days after that. You can typically shower the day after the procedure once any cover bandage is removed, but should avoid baths or submerging the incision until it is fully healed. Avoid lifting more than about 15 pounds, and avoid twisting or bending activities that strain the low back.

  • Days 1 to 3: rest, light walking as tolerated, ice as needed, no driving while on sedating medication.
  • Days 3 to 7: gradual increase in daily activity; many people with desk jobs can return to work within 2 to 3 days, while those with physically demanding jobs may need closer to a week or more.

Sources: Cleveland Clinic, Intracept Procedure recovery guidance; Intracept Patient Website, Procedure Recovery.

Weeks 2 Through 6

Most patients feel back to their normal daily routine within 1 to 2 weeks, though full activity clearance depends on your individual healing and your surgeon's assessment at your follow-up visit, usually scheduled around 2 weeks after the procedure. Physical therapy is not always required, but it can be helpful, especially if chronic pain has limited your activity or deconditioned your back muscles over time.

Sources: Intracept Patient Website, Procedure Recovery; Cleveland Clinic, Intracept Procedure.

When to Expect Pain Relief

Unlike a diagnostic nerve block, which can numb pain within minutes, basivertebral nerve ablation works by gradually stopping a damaged nerve's ability to send pain signals, so relief tends to build over time rather than appear instantly. Some patients notice improvement within the first few weeks, but the SMART trial and other studies show that pain and function scores continue to improve over the following months, with many patients reaching their best results between 3 and 12 months after treatment.

Sources: Fischgrund et al., SMART Trial 3- and 12-month results, European Spine Journal, 2018.

  1. Weeks 1 to 3: incision-site soreness fades; early, partial improvement in back pain may begin for some patients.
  2. Weeks 6 to 12: many patients notice more consistent improvement in pain and function as the nerve ablation takes full effect.
  3. Months 3 to 12: continued gradual improvement is common; in clinical trials, average disability (ODI) improvement reached its strongest levels around this window and was sustained through 24 months and beyond.

Sources: Fischgrund et al., SMART Trial 2-Year Results, International Journal of Spine Surgery, 2019.

Longer-Term Activity

There is no need for indefinite activity restriction. Once your surgeon confirms you are healing well, typically around the 2-week follow-up, most patients can gradually return to normal exercise, work duties, and recreational activity as tolerated. In the SMART trial's 5-year follow-up, about 65 percent of patients reported returning to the activity level they had before their back pain began.

Sources: CMS LCD L39644, citing SMART Trial 5-year activity outcomes.

Contact Your Doctor's Office Promptly For

  • Pain that is worsening rather than improving after the first week, or a sudden new severe pain episode.
  • Fever over 101°F, chills, or increasing redness, warmth, swelling, or drainage at the incision.
  • New numbness, tingling, or weakness in your legs.
  • New difficulty with bladder or bowel control (seek emergency care right away).
  • Persistent nausea, dizziness, or a reaction to prescribed pain medication.

Glossary of Medical Terms

TermWhat It Means
Basivertebral nerveA small nerve that runs through the center of each vertebra (spine bone) and carries pain signals from the bone itself.
Outpatient procedureA procedure that does not require an overnight hospital stay; patients go home the same day.
Conscious sedationA light sleep-like state produced by medication that keeps a patient relaxed and comfortable but breathing on their own during a procedure.
Oswestry Disability Index (ODI)A standard questionnaire that scores how much back pain limits daily activities, from 0 (no disability) to 100 (fully disabled).
Visual Analog Scale (VAS)A 0-10 (or 0-cm to 10-cm) scale patients use to rate their pain intensity.
SMART trialThe pivotal FDA clinical study (Fischgrund et al.) that tested basivertebral nerve ablation against a sham (fake) procedure.
Vertebrogenic painChronic low back pain that comes from the vertebral body (spine bone) rather than a disc, joint, or nerve root.
Radiofrequency ablation (RFA)A technique that uses heat generated by radio waves to disable a nerve's ability to send pain signals.
Intracept ProcedureThe brand name for the basivertebral nerve ablation system made by Relievant Medsystems, cleared by the FDA to treat vertebrogenic pain.
EndplateThe thin layer of bone and cartilage that caps each end of a vertebral body, next to the disc.
ResponderIn clinical trials, a patient whose pain or disability score improved by a defined amount, such as 50 percent.
Axial low back painPain centered in the lower back itself, as opposed to pain that radiates down the leg.

Sources

This handout is based on the following evidence-based, peer-reviewed, and professional-society sources:

Part 5: Long-Term Outcomes

In This Guide

  • 2-year durability data
  • 5-year durability data
  • Who tends to do best
  • Impact on future surgery and healthcare use
  • The bottom line

How Long Does Relief Last?

One of the most important questions about any back pain treatment is durability: does relief last, or fade over time? Basivertebral nerve ablation is unusual among interventional spine procedures in having long-term, sham-controlled trial data to answer this question, thanks to the SMART trial's extended follow-up, led by Dr. Jeffrey Fischgrund and colleagues.

Sources: Fischgrund et al., SMART Trial, European Spine Journal, 2018.

2-Year Results

At 24 months, patients originally treated with basivertebral nerve ablation in the SMART trial maintained a mean Oswestry Disability Index (ODI) improvement of roughly 23 to 24 points and a mean pain (VAS) reduction of about 3.6 points from baseline, corresponding to about a 53 to 54 percent average improvement in both measures. Roughly 57 to 58 percent of patients met the threshold for a meaningful pain and function responder at 2 years.

Sources: Fischgrund et al., SMART Trial 2-Year Results, International Journal of Spine Surgery, 2019.

5-Year (and Beyond) Results

The strongest evidence for durability comes from the SMART trial's long-term follow-up, published in 2020, which followed the original treatment-arm patients out to a mean of 6.4 years (range about 5.4 to 7.8 years). At that time point:

  • Disability improvement: mean ODI score improved by about 26 points, from a baseline around 43 down to about 17, sustained from the 2-year mark.
  • Pain improvement: mean VAS pain score improved by about 4.4 points, from roughly 6.7 down to about 2.4.
  • Responder rates: about 66 percent of patients had at least a 50 percent reduction in pain, and about 77 to 78 percent had at least a 15-point improvement in ODI.
  • Complete relief: about one-third (34 percent) of patients reported being completely pain-free at 5 years.

Sources: Fischgrund et al., Long-Term Outcomes Following Intraosseous Basivertebral Nerve Ablation: 5-Year Treatment Arm Results, European Spine Journal, 2020.

A separate pooled analysis combining the SMART trial with two additional prospective studies (nearly 250 basivertebral nerve ablation-treated patients with 5-year data) found broadly similar durability: roughly two-thirds of patients maintained at least a 50 percent reduction in pain, about 83 percent had at least a 2-point VAS reduction, and about 78 percent had at least a 15-point ODI improvement at 5 years, with nearly one-third reporting complete (100 percent) pain relief.

Sources: Macadaeg et al., 5-Year Pooled Analysis of Three Prospective Clinical Trials, PMC, 2024.

Impact on Future Care

Durable pain relief also appears to reduce the need for further treatment. A pooled analysis of trial data found large reductions in downstream low back pain-related healthcare use after basivertebral nerve ablation, including roughly a 74 percent decrease in opioid use and about an 84 percent decrease in the need for other spinal interventions. In a pooled one-year cohort of 247 treated patients, only about 1.6 percent went on to a subsequent lumbosacral spine surgery, such as a fusion, and even some of those cases were later attributed to a different pain source rather than treatment failure.

Sources: Low Back Pain-Related Healthcare Utilization Following Intraosseous Basivertebral Nerve Radiofrequency Ablation, Pain Medicine, 2024.

Who Tends to Do Best

Across the SMART trial and subsequent studies, the patients most likely to have strong, lasting results are those who fit the original candidacy profile closely: chronic axial low back pain (not radiating leg pain), clear Type 1 or Type 2 Modic changes on MRI at the treated levels, and no competing pain generator such as significant stenosis, instability, or prior fusion at that level. Patients with good bone health also appear to have a lower risk of the rare fracture-related complications reported in post-market safety data.

Sources: Fischgrund et al., SMART Trial subgroup and safety data, European Spine Journal, 2018/2020; FDA MAUDE adverse event analysis, PMC.

Putting It in Perspective

No back pain treatment works for everyone, and basivertebral nerve ablation is not a cure for all causes of low back pain. But for patients with confirmed vertebrogenic pain, it stands out among interventional options for having sham-controlled evidence extending out to a mean of over 6 years, a very low serious complication rate, and a low rate of subsequent spine surgery. Dr. Waldrop can help you understand whether the durability data seen in these trials is likely to apply to your specific situation.

The Bottom Line

  • In the SMART trial, the pivotal sham-controlled study, meaningful pain and disability improvement was sustained from 1 year through a mean follow-up of 6.4 years.
  • About two-thirds of treated patients maintain at least a 50 percent reduction in pain at 5 years, and roughly one-third report complete pain relief.
  • Fewer patients need opioids, additional spinal interventions, or spine surgery after successful treatment.
  • Results are most durable in carefully selected patients who match the Modic-change, axial-pain candidacy profile used in the trials.

Glossary of Medical Terms

TermWhat It Means
Basivertebral nerveA small nerve that runs through the center of each vertebra (spine bone) and carries pain signals from the bone itself.
Vertebrogenic painChronic low back pain that comes from the vertebral body (spine bone) rather than a disc, joint, or nerve root.
SMART trialThe pivotal FDA clinical study (Fischgrund et al.) that tested basivertebral nerve ablation against a sham (fake) procedure.
Sham-controlled trialA study design where some patients receive a fake version of the treatment so researchers can measure the treatment's true effect.
ResponderIn clinical trials, a patient whose pain or disability score improved by a defined amount, such as 50 percent.
Oswestry Disability Index (ODI)A standard questionnaire that scores how much back pain limits daily activities, from 0 (no disability) to 100 (fully disabled).
Visual Analog Scale (VAS)A 0-10 (or 0-cm to 10-cm) scale patients use to rate their pain intensity.
Modic changesSpecific patterns seen on an MRI scan at the endplate (the cap of bone next to a disc) that suggest inflammation or bone marrow change linked to vertebrogenic pain.
Type 1 Modic changeAn MRI pattern showing active inflammation and swelling in the vertebral bone marrow next to a disc.
Type 2 Modic changeAn MRI pattern showing fatty replacement of bone marrow, a later-stage change often still linked to pain.
Intracept ProcedureThe brand name for the basivertebral nerve ablation system made by Relievant Medsystems, cleared by the FDA to treat vertebrogenic pain.
Radiofrequency ablation (RFA)A technique that uses heat generated by radio waves to disable a nerve's ability to send pain signals.

Sources

This handout is based on the following evidence-based, peer-reviewed, and professional-society sources:

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