Chronic Low-back PainIMPROVENCT06827262
Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain
An observational study of Chronic Low-back Pain and Vertebrogenic Pain Syndrome, run by Boston Scientific Corporation at 22 sites in United States.
Trial summary
Compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain, Vertebrogenic Pain Syndrome
- What is being tested?
- Intracept™ Intraosseous Nerve Ablation
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- 22 sitesUnited States
- Study dates
- 26 Mar 2025to Jul 2034
- How long will I take part?
- 60 Months
- 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: Subjects are established patients in a medical practice who will receive intraosseous nerve ablation to treat vertebrogenic pain utilizing a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use according to standard of care.
Who may be able to join
- Study candidate is scheduled to be treated with a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use (IFU).
- Signed a valid, IRB/EC-approved informed consent form.
Who cannot join
- Meets any contraindications per locally applicable Instructions for Use (IFU).
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
United States22 sites, 19 recruiting
- Recruiting
Illinois Bone and Joint Institute
Barrington, Illinois, 60010
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Novant Health Spine Specialists
Bermuda Run, North Carolina, 27106
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Active, not recruiting
Pacific Sports and Spine
Eugene, Oregon, 97404
- Recruiting
Flagstaff Bone & Joint
Flagstaff, Arizona, 86001
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Cy-Pain and Spine
Houston, Texas, 77065
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Horizon Clinical Research, LLC
Jasper, Georgia, 30143
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
MarinHealth Spine Institute
Larkspur, California, 94939
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Commonwealth Pain and Spine
Lexington, Kentucky, 40509
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
iSpine Clinics
Maple Grove, Minnesota, 55369
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, 70115
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Orlando Regional Medical Center
Orlando, Florida, 32806
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Innovative Pain and Wellness
Phoenix, Arizona, 85014
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
New York Spine and Pain Specialists
Port Jefferson Station, New York, 11776
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Withdrawn
North Idaho Day Surgery, LLC
Post Falls, Idaho, 83854
- Active, not recruiting
University of Rochester
Rochester, New York, 14618
- Recruiting
CentraCare Health System
Saint Cloud, Minnesota, 56303
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Stanford University Medical Center
Stanford, California, 94305
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10461
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
The Spine Wellness Center in Westport
Westport, Connecticut, 06880
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
About this study
Compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.
Read the detailed description
The objective of this study is to compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.
- Conditions
- Chronic Low-back Pain, Vertebrogenic Pain Syndrome
- Being tested
- Intracept™ Intraosseous Nerve Ablation
- Keywords
- Intraosseous basivertebral nerve ablation, Axial low back pain, Low Back Pain
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracept™ Intraosseous Nerve AblationDevice
Intracept™ Intraosseous Nerve Ablation for treatment of patients diagnosed with vertebrogenic pain
| Study group | Role | What they receive |
|---|---|---|
| Intracept™ Intraosseous Nerve Ablation Systems | Subjects with pain treated with a commercially approved Intracept™ Intraosseous Nerve Ablation System Receives: Device: Intracept™ Intraosseous Nerve Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disability (Oswestry Disability Index (ODI) from Baseline
The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The published minimally clinically important difference for change in ODI is 10 points.
Measured: 60-months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start26 Mar 2025
- Primary completionJul 2034 (estimated)
- Study completionJul 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- 1,500 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalie Bloom Lyons, M.A., Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827262
- Sponsor's protocol ID
- REL025
- Acronym
- IMPROVE
- Status last verified
- Oct 2026
- First submitted
- 10 Feb 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain
- ClinicalTrials.gov ID
- NCT06827262
- Acronym / sponsor ID
- IMPROVE / REL025
- Conditions
- Chronic Low-back Pain, Vertebrogenic Pain Syndrome
- Keywords
- Intraosseous basivertebral nerve ablation, Axial low back pain, Low Back Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- Jul 2034 (estimated)
- Study completion
- Jul 2034 (estimated)
- First posted
- 14 Feb 2025 (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.
Compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.
Detailed description
The objective of this study is to compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracept™ Intraosseous Nerve Ablation Systems | – | Device: Intracept™ Intraosseous Nerve AblationSubjects with pain treated with a commercially approved Intracept™ Intraosseous Nerve Ablation System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are established patients in a medical practice who will receive intraosseous nerve ablation to treat vertebrogenic pain utilizing a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use according to standard of care.
Key inclusion criteria (2 listed)
- Study candidate is scheduled to be treated with a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use (IFU).
- Signed a valid, IRB/EC-approved informed consent form.
Key exclusion criteria (1 listed)
- Meets any contraindications per locally applicable Instructions for Use (IFU).
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 |
|---|---|---|
| Intracept™ Intraosseous Nerve AblationIntracept™ Intraosseous Nerve Ablation for treatment of patients diagnosed with vertebrogenic pain | Device | Intracept™ Intraosseous Nerve Ablation Systems |
Primary outcome
Change in Disability (Oswestry Disability Index (ODI) from Baseline
Time frame: 60-months post-procedure
The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The published minimally clinically important difference for change in ODI is 10 points.
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 9 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Low-back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
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Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
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.
Natalie Bloom Lyons, M.A. study director
Boston Scientific Corporation
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low-back Pain and Vertebrogenic Pain Syndrome, run by Boston Scientific Corporation at 22 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 2 inclusion and 1 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 9 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 22 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 Ann Yamano (855-213-9890, BSNClinicalTrials@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disability (Oswestry Disability Index (ODI) from Baseline (time frame: 60-months post-procedure). 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 9 Oct 2026.