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INTRACEPT: Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP (CLBP)

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ClinicalTrials.gov Identifier: NCT03246061
Recruitment Status : Active, not recruiting
First Posted : August 11, 2017
Results First Posted : December 22, 2020
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Relievant Medsystems, Inc.

Brief 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). 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.


Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Device: Intracept System Other: Standard Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: BVN Ablation vs Standard Care Control
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: INTRACEPT: A Prospective, Randomized, Multi-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
Actual Study Start Date : August 24, 2017
Actual Primary Completion Date : January 18, 2019
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: BVN Ablation
BVN ablation with continued standard care
Device: Intracept System
BVN ablation using radiofrequency energy

Active Comparator: Standard Care Control
Continue with non-surgical standard care
Other: Standard Care
Non-surgical standard care




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS) [ Time Frame: 3 months post treatment / randomization ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03246061


Locations
Show Show 18 study locations
Sponsors and Collaborators
Relievant Medsystems, Inc.
Investigators
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Principal Investigator: Steven R Garfin, MD Independent
  Study Documents (Full-Text)

Documents provided by Relievant Medsystems, Inc.:
Additional Information:
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Responsible Party: Relievant Medsystems, Inc.
ClinicalTrials.gov Identifier: NCT03246061    
Other Study ID Numbers: CIP 0006
First Posted: August 11, 2017    Key Record Dates
Results First Posted: December 22, 2020
Last Update Posted: October 8, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Trial results will be published at the completion of the trial
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: End of trial
Access Criteria: To be determined

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations