Chronic Low Back PainCLBPNCT03246061
INTRACEPT: Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP
A study testing Intracept System in people with Chronic Low Back Pain, run by Relievant Medsystems, Inc. at 18 sites in United States.
Trial summary
Prospective, open-label, 1:1 randomized controlled trial of Basivertebral nerve (BVN) Ablation arm vs Standard Care Control for the treatment of vertebrogenic chronic low back pain (CLBP). Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Intracept System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 18 sitesUnited States
- Study dates
- 24 Aug 2017to 5 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Skeletally mature subjects at least 25 years of age
- Chronic lower back pain for at least 6 months
- Failure to respond to at least 6 months of non-operative conservative management
Who cannot join
- Radicular pain
- Current or history of spinal infection
- Modic changes at vertebral bodies other than L3 to S1
- Contraindication to MRI
- Pregnant, lactating or plan to become pregnant in next year
- Has life expectancy of less than 2 years
- Compensated injuries or ongoing litigation regarding back pain/injury, or financial incentive to remain impaired
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Emory University School of Medicine
Atlanta, Georgia, 30329
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
OrthoCarolina
Charlotte, North Carolina, 28207
Bassett Medical Center
Cooperstown, New York, 13326
Clinical Investigations
Edmond, Oklahoma, 73013
Pacific Sports and Spine
Eugene, Oregon, 97401
Denver Back Specialists
Greenwood Village, Colorado, 80111
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
St Luke's Hospital
Kansas City, Missouri, 64111
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Keck Medicine of USC
Los Angeles, California, 90033
Drug Studies America
Marietta, Georgia, 30060
Temple University
Philadelphia, Pennsylvania, 19147
Barrow Brain and Spine
Phoenix, Arizona, 85048
Stanford Orthopaedic Surgery
Redwood City, California, 94063
University of Rochester
Rochester, New York, 14618
Beaumont Hospital
Royal Oak, Michigan, 48073
Precision Spine Center
Tyler, Texas, 75701
About this study
Official title: INTRACEPT: A Prospective, Randomized, Multi-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
Prospective, open-label, 1:1 randomized controlled trial of Basivertebral nerve (BVN) Ablation arm vs Standard Care Control for the treatment of vertebrogenic chronic low back pain (CLBP). Participants in the the BVN Ablation arm will receive radiofrequency ablation of the BVN using the Intracept procedure for treatment of up to 4 vertebral bodies (L3 to S1). Participants in the Standard Care Control arm will continue on non-surgical standard care and will be offered optional crossover after 12 months of follow-up with follow-up of 6 months post crossover treatment.
The study had a pre-specified Interim Analysis with stopping rules for superiority when approximately 60% of the randomized participants have completed their 3-month primary endpoint study visit. An independent Data Safety Management Board (DSMB) reviewed the interim analysis results and recommended stopping enrollments for superiority and offering early crossover to the control arm participants.
Read the detailed description
Participants in the BVN Ablation arm will be followed for 24 months following treatment. BVN Ablation arm participants will be approached to participate in a sub study of 3 additional years of follow-up at their 24 month visit (total of 5 years of follow-up).
Control arm subjects who were originally to be offered optional crossover treatment after the 12 month follow-up visit were offered crossover per the DSMB recommendation at a mean of 176.5 days.
- Conditions
- Chronic Low Back Pain
- Being tested
- Intracept System, Standard Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracept SystemDevice
BVN ablation using radiofrequency energy
Standard CareOther
Non-surgical standard care
| Study group | Role | What they receive |
|---|---|---|
| BVN Ablation | Active comparator | BVN ablation with continued standard care Receives: Device: Intracept System |
| Standard Care Control | Active comparator | Continue with non-surgical standard care Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI)
Difference between arms in LS Mean change in ODI (baseline to 3 months post-treatment). ODI is measured on a scale of 0 (no disability) to 100 (complete disability), with categories of 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 minimally clinically important difference for this tool is considered to be a 10 point reduction in ODI from a baseline in a patient.
These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.
Measured: 3 months
Secondary outcomes (1)
Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS)
Difference between arms in LS Mean reduction in Visual Analog Scale (VAS) for low back pain from baseline to 3 months post treatment. VAS is a 10 point scale with 0 being no pain and 10 being worst imaginable pain. Participants are asked to indicate an x on the scale that corresponds to their perceived level of pain in their low back. The published minimal clinically important change in VAS is 2 points from baseline.
These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.
Measured: 3 months post treatment / randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start24 Aug 2017
- Primary completion18 Jan 2019
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- BVN Ablation vs Standard Care Control
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Relievant Medsystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven R Garfin, MD, Principal investigator, Independent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246061
- Sponsor's protocol ID
- CIP 0006
- Acronym
- CLBP
- Status last verified
- Mar 2024
- First submitted
- 8 Aug 2017
- Last updated
- 2 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Trial results will be published at the completion of the trial
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTRACEPT: A Prospective, Randomized, Multi-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03246061
- Acronym / sponsor ID
- CLBP / CIP 0006
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Relievant Medsystems, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Posted 22 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, open-label, 1:1 randomized controlled trial of Basivertebral nerve (BVN) Ablation arm vs Standard Care Control for the treatment of vertebrogenic chronic low back pain (CLBP). Participants in the the BVN Ablation arm will receive radiofrequency ablation of the BVN using the Intracept procedure for treatment of up to 4 vertebral bodies (L3 to S1). Participants in the Standard Care Control arm will continue on non-surgical standard care and will be offered optional crossover after 12 months of follow-up with follow-up of 6 months post crossover treatment.
The study had a pre-specified Interim Analysis with stopping rules for superiority when approximately 60% of the randomized participants have completed their 3-month primary endpoint study visit. An independent Data Safety Management Board (DSMB) reviewed the interim analysis results and recommended stopping enrollments for superiority and offering early crossover to the control arm participants.
Detailed description
Participants in the BVN Ablation arm will be followed for 24 months following treatment. BVN Ablation arm participants will be approached to participate in a sub study of 3 additional years of follow-up at their 24 month visit (total of 5 years of follow-up).
Control arm subjects who were originally to be offered optional crossover treatment after the 12 month follow-up visit were offered crossover per the DSMB recommendation at a mean of 176.5 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- BVN Ablation vs Standard Care Control
| Arm | Type | Receives |
|---|---|---|
| BVN Ablation | Active comparator | Device: Intracept SystemBVN ablation with continued standard care |
| Standard Care Control | Active comparator | Other: Standard CareContinue with non-surgical standard care |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Skeletally mature subjects at least 25 years of age
- Chronic lower back pain for at least 6 months
- Failure to respond to at least 6 months of non-operative conservative management
Key exclusion criteria (7 listed)
- Radicular pain
- Current or history of spinal infection
- Modic changes at vertebral bodies other than L3 to S1
- Contraindication to MRI
- Pregnant, lactating or plan to become pregnant in next year
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 SystemBVN ablation using radiofrequency energy | Device | BVN Ablation |
| Standard CareNon-surgical standard care | Other | Standard Care Control |
Primary outcome
Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI)
Time frame: 3 months
Difference between arms in LS Mean change in ODI (baseline to 3 months post-treatment). ODI is measured on a scale of 0 (no disability) to 100 (complete disability), with categories of 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 minimally clinically important difference for this tool is considered to be a 10 point reduction in ODI from a baseline in a patient. These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.
1 secondary outcome
Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS)
Time frame: 3 months post treatment / randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- INTRACEPT Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Trial results will be published at the completion of the trial
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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.
Steven R Garfin, MD principal investigator
Independent
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracept System in people with Chronic Low Back Pain, run by Relievant Medsystems, Inc. at 18 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
Yes. Results are posted in the registry (first posted 22 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI) (time frame: 3 months). 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 2 Apr 2024.