Chronic Low Back PainCLBPNCT03630133
Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
A study testing Intracept System Ablation in people with Chronic Low Back Pain, run by Relievant Medsystems, Inc. at 1 site in United States.
Trial summary
Objective of study is to evaluate the procedural success rate, clinical effectiveness, and heath-economic profile using the Intercept Intraosseous Nerve Ablation System in adult subjects with chronic low back pain in the post-market setting Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Intracept System Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2018to 29 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Skeletally mature subjects age 25-70 years, inclusive
- Chronic lower back pain for at least six months
- Failure to respond to at least six months of non-operative conservative management
- Oswestry Disability Index (ODI) at time of evaluation of at least 30 points
- Modic changes (Type 1 or 2) in at least one vertebral endplate, at one or more levels from L3 to S1
Who cannot join
- Radicular pain by history or evidence of pain neurological deficit within the past one year.
- Previous surgery performed on the lumbar spine
- Current or history of symptomatic spinal stenosis
- Current or history of osteoporotic or tumor-related vertebral body compression fracture
- Current or history of vertebral cancer or spinal metastasis
- Current or history of spinal infection
Show all 14Show fewer
- Metabolic bone disease
- BMI greater or equal to 40
- Any radiographic evidence of other important back pathology
- MRI evidence of Modic changes, Type 1 or 2 at greater than 3 vertebral bodies or at non-consecutive levels, or at vertebral bodies other than L3 to S1
- Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
- Subjects who are bed bound
- Demonstrates 3 or more Waddell's signs of Inorganic Behavior
- Any evidence of current systemic infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open-Label, Single-Arm, Single-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
Objective of study is to evaluate the procedural success rate, clinical effectiveness, and heath-economic profile using the Intercept Intraosseous Nerve Ablation System in adult subjects with chronic low back pain in the post-market setting
Read the detailed description
This is a prospective, open-label, single-arm, single-center study. There is no randomization or blinding. Subjects will receive the Intercept System procedure to treat one or two motion segments at L3/L4, L4/L5, or L5/S1 as identified by Modic Type 1 or 2 changes.
- Conditions
- Chronic Low Back Pain
- Being tested
- Intracept System Ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracept System AblationDevice
Radiofrequency ablation using Intracept System
| Study group | Role | What they receive |
|---|---|---|
| Intracept System Ablation | Experimental | Single Arm Receives: Device: Intracept System Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
Mean change in Oswestry Disability Index Score from baseline to 3 months post-treatment. Scale is measured from 0 to 100, better to worse respectively.
Measured: 3 months
Secondary outcomes (2)
Visual Analog Scale (VAS)
Mean change in Visual Analog Scale (VAS) pain score from baseline to 3, 6, 9 and 12 months post-treatment. Scale is measured from 0 to 10, better to worse respectively.
Measured: 3, 6, 9, and 12 months
Oswestry Disability Index (ODI)
Mean change in Oswestry Disability Index (ODI) score from baseline to 6, 9 and 12 months post-treatment. Scale is measured from 0 to 100, better to worse respectively.
Measured: 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start8 May 2018
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Why it stopped: Combined with NCT03266107
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.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Relievant Medsystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Macadaeg, MD, Principal investigator, Indiana Spine Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630133
- Sponsor's protocol ID
- CIP 0008
- Acronym
- CLBP
- Status last verified
- Jun 2020
- First submitted
- 9 Aug 2018
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Single-Arm, Single-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03630133
- Acronym / sponsor ID
- CLBP / CIP 0008
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Combined with NCT03266107
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Relievant Medsystems, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 May 2018 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 14 Aug 2018 (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.
Objective of study is to evaluate the procedural success rate, clinical effectiveness, and heath-economic profile using the Intercept Intraosseous Nerve Ablation System in adult subjects with chronic low back pain in the post-market setting
Detailed description
This is a prospective, open-label, single-arm, single-center study. There is no randomization or blinding. Subjects will receive the Intercept System procedure to treat one or two motion segments at L3/L4, L4/L5, or L5/S1 as identified by Modic Type 1 or 2 changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracept System Ablation | Experimental | Device: Intracept System AblationSingle Arm |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Skeletally mature subjects age 25-70 years, inclusive
- Chronic lower back pain for at least six months
- Failure to respond to at least six months of non-operative conservative management
- Oswestry Disability Index (ODI) at time of evaluation of at least 30 points
- Modic changes (Type 1 or 2) in at least one vertebral endplate, at one or more levels from L3 to S1
Key exclusion criteria (14 listed)
- Radicular pain by history or evidence of pain neurological deficit within the past one year.
- Previous surgery performed on the lumbar spine
- Current or history of symptomatic spinal stenosis
- Current or history of osteoporotic or tumor-related vertebral body compression fracture
- Current or history of vertebral cancer or spinal metastasis
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 System AblationRadiofrequency ablation using Intracept System | Device | Intracept System Ablation |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: 3 months
Mean change in Oswestry Disability Index Score from baseline to 3 months post-treatment. Scale is measured from 0 to 100, better to worse respectively.
2 secondary outcomes
Visual Analog Scale (VAS)
Time frame: 3, 6, 9, and 12 months
Oswestry Disability Index (ODI)
Time frame: 6, 9, and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Individual participant dataSharing planned: Yes
Related trials for Chronic Low Back Pain
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Chronic Non Specific Mechanical 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.
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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. This study is not recruiting at the moment.
Kevin Macadaeg, MD principal investigator
Indiana Spine Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracept System Ablation in people with Chronic Low Back Pain, run by Relievant Medsystems, Inc. at 1 site 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 14 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: withdrawn, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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) (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 17 Jun 2020.