Chronic Low Back PainNCT03266107
Study of Basivertebral Nerve Ablation Treatment of Chronic Low Back Pain
A study testing Intracept in people with Chronic Low Back Pain, run by Relievant Medsystems, Inc. at 2 sites in United States.
Trial summary
Prospective, single arm, open label, multi-center study to evaluated the effectiveness of intraosseous basivertebral nerve radiofrequency ablation using the Intracept System. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Feb 2018to 17 Feb 2020
- 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 low back pain for at least 6 months
- Failure to respond to at least 6 months of non-operative conservative management
- Oswestry Disability Index (ODI) at least 30 points
- Modic changes Type 1 or 2
Who cannot join
- Current or history of vertebral cancer or spinal metastasis
- History of a fragility fracture
- Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
- Disc extrusion or protrusion
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Seton Spine and Scoliosis Center
Austin, Texas, 78731
Indiana Spine Group
Carmel, Indiana, 46032
About this study
Official title: A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
Prospective, single arm, open label, multi-center study to evaluated the effectiveness of intraosseous basivertebral nerve radiofrequency ablation using the Intracept System.
Read the detailed description
This is a prospective, open-label, single-arm study of patients diagnosed with vertebrogenic low back pain for a minimum of 6 months with conservative care. Participants will receive the Intracept System procedure to ablate the basivertebral nerve within the vertebral body. Treatment is performed on all vertebral bodies with Modic type 1 or type 2 changes on MRI from L3-S1.
- Conditions
- Chronic Low Back Pain
- Being tested
- Intracept
- Keywords
- Vertebrogenic Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntraceptDevice
Radiofrequency ablation of the basivertebral nerve using the Intracept System
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | BVN Ablation Receives: Device: Intracept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI) - 3 Months
Change in mean Oswestry Disability Index (ODI) total score from baseline to 3 months post-treatment. ODI total score 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 in ODI from baseline is considered to be a 10 points reduction from baseline.
Measured: 3 months
Secondary outcomes (8)
Visual Analog Scale (VAS) - 3 Months
Change in the mean visual analog scale (VAS) low back pain from baseline to 3 months post treatment. VAS is a 10 point numeric scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference is a 2 point reduction from baseline.
Measured: 3 Months
ODI Responder Rate - 3-Month
Number \& percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) from baseline to 3 months post treatment. ODI is scored 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 10 points.
Measured: 3 Months
VAS Responder Rate - 3 Month
Number and percentage of participants with a greater than or equal to 2 point reduction from baseline in visual analog scale (VAS) for low back pain at 3 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction.
Measured: 3 Months
ODI -12 Months
Change in mean Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. ODI total score is 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 10 point reduction in ODI.
Measured: 12 Months
VAS - 12 Month
Change in mean visual analog scale (VAS) for low back pain score from baseline at 12 months. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction.
Measured: 12 Months
ODI Responder Rate - 12-Month
Number and percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. ODI total score 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 10 points.
Measured: 12 Months
VAS Responder Rate - 12 Months
Number and percent of participants with a reduction of greater than or equal to 2 points of the visual analog scale (VAS) at 12 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction in score.
Measured: 12 Months
VAS Reduction 50% or More - 12 Month
Number and percent of participants that reported a 50% or greater reduction in Visual Analog Scale (VAS) from baseline to 12 months.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start14 Feb 2018
- Primary completion17 Feb 2020
- Study completion17 Feb 2020
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Relievant Medsystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eeric Truumees, MD, Principal investigator, IndependentKevin Macadaeg, MD, Principal investigator, Independent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266107
- Sponsor's protocol ID
- CIP 0007 and CIP 0008
- Status last verified
- Dec 2020
- First submitted
- 16 Aug 2017
- Last updated
- 22 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Results
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03266107
- Acronym / sponsor ID
- CIP 0007 and CIP 0008
- Conditions
- Chronic Low Back Pain
- Keywords
- Vertebrogenic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Relievant Medsystems, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 17 Feb 2020 (actual)
- First posted
- 29 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, single arm, open label, multi-center study to evaluated the effectiveness of intraosseous basivertebral nerve radiofrequency ablation using the Intracept System.
Detailed description
This is a prospective, open-label, single-arm study of patients diagnosed with vertebrogenic low back pain for a minimum of 6 months with conservative care. Participants will receive the Intracept System procedure to ablate the basivertebral nerve within the vertebral body. Treatment is performed on all vertebral bodies with Modic type 1 or type 2 changes on MRI from L3-S1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: IntraceptBVN Ablation |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Skeletally mature subjects at least 25 years of age
- Chronic low back pain for at least 6 months
- Failure to respond to at least 6 months of non-operative conservative management
- Oswestry Disability Index (ODI) at least 30 points
- Modic changes Type 1 or 2
Key exclusion criteria (4 listed)
- Current or history of vertebral cancer or spinal metastasis
- History of a fragility fracture
- Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
- Disc extrusion or protrusion
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 |
|---|---|---|
| IntraceptRadiofrequency ablation of the basivertebral nerve using the Intracept System | Device | Treatment |
Primary outcome
Oswestry Disability Index (ODI) - 3 Months
Time frame: 3 months
Change in mean Oswestry Disability Index (ODI) total score from baseline to 3 months post-treatment. ODI total score 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 in ODI from baseline is considered to be a 10 points reduction from baseline.
8 secondary outcomes
Visual Analog Scale (VAS) - 3 Months
Time frame: 3 Months
ODI Responder Rate - 3-Month
Time frame: 3 Months
VAS Responder Rate - 3 Month
Time frame: 3 Months
ODI -12 Months
Time frame: 12 Months
VAS - 12 Month
Time frame: 12 Months
ODI Responder Rate - 12-Month
Time frame: 12 Months
VAS Responder Rate - 12 Months
Time frame: 12 Months
VAS Reduction 50% or More - 12 Month
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Results
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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.
Eeric Truumees, MD principal investigator
Independent
Kevin Macadaeg, MD principal investigator
Independent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracept in people with Chronic Low Back Pain, run by Relievant Medsystems, Inc. at 2 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 5 inclusion and 4 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 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Oswestry Disability Index (ODI) - 3 Months (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 22 Dec 2020.