Chronic Low Back PainSMARTNCT03997825
Five-Plus Year Follow-Up of SMART Randomized Controlled Trial
An observational study of Chronic Low Back Pain, run by Relievant Medsystems, Inc. at 13 sites in United States.
Trial summary
The objective of this study is to evaluate long-term ongoing effectiveness of the Intracept Intraosseous Nerve Ablation System for the treatment of chronic low back pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Basivertebral Nerve (BVN) Ablation
- Type of treatment
- Medical device
- How many people
- 117 participants
- Where
- 13 sitesUnited States
- Study dates
- 13 Jun 2019to 8 Nov 2019
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 117 U.S. subjects treated per protocol in the treatment arm of the original SMART trial in the U.S.
Who may be able to join
- LBP at least 6 months from original SMART Trial
- RF Ablation Arm from SMART Trial
Who cannot join
- -Control Arm Subjects from SMART Trial
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Seton Spine and Scoliosis Center
Austin, Texas, 78731
Rothman Orthopedic Institute
Bensalem, Pennsylvania, 19020
Indiana Spine Group
Carmel, Indiana, 46032
OrthoCarolina
Charlotte, North Carolina, 28207
SpineCare Medical Group
Daly City, California, 94015
Pacific Sports and Spine
Eugene, Oregon, 97401
Memorial Orthopedic Surgical Group
Long Beach, California, 90806
Cedars Sinai Spine Center
Los Angeles, California, 90048
Drug Studies of America
Marietta, Georgia, 30060
Desert Institute for Spine Care
Phoenix, Arizona, 85020
Virginia iSpine Physicians
Richmond, Virginia, 23235
Maine Medical Partners
Scarborough, Maine, 04074
Michigan Orthopedics Instititute
Southfield, Michigan, 48033
About this study
Official title: Five-Plus Year Follow-Up of SMART (Surgical Multicenter Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain) Trial
The objective of this study is to evaluate long-term ongoing effectiveness of the Intracept Intraosseous Nerve Ablation System for the treatment of chronic low back pain.
Read the detailed description
This is a prospective multi-center, nonintervention, observational, single arm post market data collection of the 5+ year effectiveness and satisfaction outcome for the SMART trial population.
- Conditions
- Chronic Low Back Pain
- Being tested
- Basivertebral Nerve (BVN) Ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basivertebral Nerve (BVN) AblationDevice
Single follow-up visit of previously treated participants from the SMART trial.
What is being measured
The primary outcome is the main question the study is designed to answer.
LS Mean Reduction in Oswestry Disability Index (ODI) From Baseline
Validated questionnaire of low back pain related disability. Comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The 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). Difference in mean ODI at baseline and 5 years post treatment measurements.
Measured: Difference between baseline and 5 year post treatment measurements
Secondary outcomes (5)
LS Mean Reduction in VAS From Baseline
Numeric pain scale with minimum of 0 to maximum of 10; with 0 being no pain and 10 being worst imaginable pain. Difference in mean VAS at baseline and at 5 years post treatment.
Measured: Difference between baseline and 5 year post treatment measurements
Responder Rates
Proportion of participants that achieve a threshold of > 15 point reduction in ODI and > 2 point reduction in VAS calculated as the difference between the baseline measurements and the 5 year post treatment measurements.
Measured: At 5 year post treatment
Narcotics Use
Proportion of participants using a narcotic more than once per week in the 30 days prior to the study visit. Difference in baseline to 5 year post treatment percentage measurements.
Measured: Difference between baseline and 5 years post treatment.
Injections
Proportion of participants receiving an injection for low back pain (adjudicated as same location and etiology as BVN ablation treatment) compared to baseline. Difference in percentage of participants at baseline and 5 years post treatment measurements.
Measured: Difference from baseline percentage measurement to 5 years post treatment measurement
Interventions
Proportion of participants receiving a pain intervention or surgery for low back pain (adjudicated as the same location and etiology as BVN ablation treatment) from procedure date to 5 year visit date.
Measured: Measured form treatment data to 5 years post treatment visit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start13 Jun 2019
- Primary completion8 Nov 2019
- Study completion8 Nov 2019
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Relievant Medsystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeff Fischgrund, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997825
- Sponsor's protocol ID
- CIP 0011
- Acronym
- SMART
- Status last verified
- Dec 2020
- First submitted
- 7 May 2019
- Last updated
- 13 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five-Plus Year Follow-Up of SMART (Surgical Multicenter Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain) Trial
- ClinicalTrials.gov ID
- NCT03997825
- Acronym / sponsor ID
- SMART / CIP 0011
- Conditions
- Chronic Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Relievant Medsystems, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 25 Jun 2019 (actual)
- Results
- Posted 4 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate long-term ongoing effectiveness of the Intracept Intraosseous Nerve Ablation System for the treatment of chronic low back pain.
Detailed description
This is a prospective multi-center, nonintervention, observational, single arm post market data collection of the 5+ year effectiveness and satisfaction outcome for the SMART trial population.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 117 U.S. subjects treated per protocol in the treatment arm of the original SMART trial in the U.S.
Key inclusion criteria (2 listed)
- LBP at least 6 months from original SMART Trial
- RF Ablation Arm from SMART Trial
Key exclusion criteria (1 listed)
- -Control Arm Subjects from SMART Trial
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 |
|---|---|---|
| Basivertebral Nerve (BVN) AblationSingle follow-up visit of previously treated participants from the SMART trial. | Device | – |
Primary outcome
LS Mean Reduction in Oswestry Disability Index (ODI) From Baseline
Time frame: Difference between baseline and 5 year post treatment measurements
Validated questionnaire of low back pain related disability. Comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The 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). Difference in mean ODI at baseline and 5 years post treatment measurements.
5 secondary outcomes
LS Mean Reduction in VAS From Baseline
Time frame: Difference between baseline and 5 year post treatment measurements
Responder Rates
Time frame: At 5 year post treatment
Narcotics Use
Time frame: Difference between baseline and 5 years post treatment.
Injections
Time frame: Difference from baseline percentage measurement to 5 years post treatment measurement
Interventions
Time frame: Measured form treatment data to 5 years post treatment visit date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Jeff Fischgrund, MD principal investigator
Corewell Health East
13 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, run by Relievant Medsystems, Inc. at 13 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: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 4 Nov 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?
LS Mean Reduction in Oswestry Disability Index (ODI) From Baseline (time frame: Difference between baseline and 5 year post treatment measurements). 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 13 Jan 2021; AzTrials last refreshed its copy on 26 Oct 2026.