Low Back PainSMARTNCT01446419
SMART Clinical Study: Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain
A study testing Intracept Treatment in people with Low Back Pain, run by Relievant Medsystems, Inc. at 13 sites in United States.
Trial summary
To evaluate the safety and efficacy of RF ablation using the Intracept Intraosseous Nerve Ablation System to ablate intraosseous nerves for the relief of chronic axial low back pain. This is a prospective, double-blind, randomized, sham-controlled clinical trial with an optional crossover component. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Intracept Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 13 sitesUnited States
- Study dates
- Oct 2011to Mar 2016
- 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 patients age 25 - 70 years, inclusive
- Chronic lower back pain for at least six (6) months
- Failure to respond to at least six (6) months of non-operative conservative management. The minimum requirement is as follows:
- Analgesic therapy (minimum of 2 weeks) and a minimum of 4 weeks of NSAID therapy
- Supervised exercise program(minimum of 12 sessions)
- Oswestry Disability Index (ODI) at time of evaluation of at least 30 points
Show all 11Show fewer
- Baseline Visual Analog Scale (VAS) of at least 4cm on a 10cm scale
- The following test indicating that the vertebral body is the source of pain:
- 1.MRI showing Type 1 or Type II Modic changes at least one vertebral endplate, at one or more levels from L3 to S1
- Understands the local language and is willing and able to follow the requirements of the protocol
- Understands the informed consent and signs the institutional review board/ independent ethics committee (IRB/IEC) approved informed consent form
Who cannot join
- Radicular pain by history or evidence of pain or neurological deficit in a dermatomal zone at or below the medial thigh.
- Previous surgery performed on the lumbar spine
- History of symptomatic spinal stenosis
- History of osteoporotic or tumor-related vertebral body compression fracture
- History of vertebral cancer or spinal metastasis
- History of spinal infection
Show all 36Show fewer
- Metabolic bone disease (e.g. osteogenesis imperfecta)
- BMI ≥40
- Osteoporosis, defined as T score <-2.5
- Any radiographic evidence of other important back pathology, such as:
- Nerve root compression or severe effacement of the thecal sac that correlates with radicular pain or muscle weakness
- Disc extrusion or disc protrusion >5mm
- Facet arthrosis or facet effusion at any lumbar level that correlates with clinical evidence of facet mediated low back pain
- Spondylolisthesis 2mm or greater at any level
- Spondylolysis at any level
- MRI evidence of Modic changes, Type I or Type II at greater than 3 vertebral bodies.
- Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
- Demonstrates 3 or more Waddell's signs of Inorganic Behavior
- Any evidence of current systemic infection
- Uncorrected bleeding diathesis
- Any neurologic problem that prevents early mobilization after surgery or interferes with assessment of ODI
- Contraindication to MRI or patients who have allergies to the components of the Intracept device
- Pregnant, lactating or plan to become pregnant in next year
- Diabetes requiring daily insulin
- Current use of steroid therapy, with the exception of inhalation steroids for asthma
- Evidence of mental instability or uncontrolled depression; patients requiring anti-depressants or anti-psychotics within 3 months of enrollment are not eligible; patients with a Beck Depression Score of greater than 24 are not eligible
- Receiving Workmen's Compensation
- Currently involved in litigation regarding back pain/injury or financial incentive to remain impaired
- Any medical condition that impairs follow-up
- Contraindications to the proposed anesthetic protocol.
- Evidence of substance abuse; patients using prescribed extended release narcotics are not eligible (e.g. fentanyl patch,MS contin, oxycontin)
- Known to require at the time of screening and/or randomization, additional surgery to the lumbar spinal region within six months
- Being treated with radiation, chemotherapy, immunosuppression, or chronic steroid therapy (prednisone use up to 5 mg/qd or its equivalent is allowed)
- Has a life expectancy of less than 1 year
- Has active implantable devices, such as cardiac pacemakers, spinal cord stimulators, etc.
- Is a prisoner
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Seton Spine & Scoliosis Center
Austin, Texas, 78731
Indiana Spine Group
Carmel, Indiana, 46032
OrthoCarolina
Charlotte, North Carolina, 28207
SpineCare Medical Group
Daly City, California, 94015
NeuroSpine Institute
Eugene, Oregon, 97401
Memorial Orthopedic Surgical Group
Long Beach, California, 90806
Pain Center Solutions
Marietta, Georgia, 30060
Rothman Institute
Philadelphia, Pennsylvania, 19107
Desert Institute for Spine Care
Phoenix, Arizona, 85020
Virginia iSpine Physicians
Richmond, Virginia, 23235
The Spine Institute
Santa Monica, California, 90403
Maine Medical Partners
Scarborough, Maine, 04074
Partners in Research and Educational Studies of Spinal Disorders (PressD)
Southfield, Michigan, 48033
About this study
Official title: A Prospective Randomized, Double-blind, Controlled Investigation Evaluating the Intracept Intraosseous Nerve Ablation System for the Reduction of Pain in Patients With Chronic Axial Low Back Pain
To evaluate the safety and efficacy of RF ablation using the Intracept Intraosseous Nerve Ablation System to ablate intraosseous nerves for the relief of chronic axial low back pain. This is a prospective, double-blind, randomized, sham-controlled clinical trial with an optional crossover component.
- Conditions
- Low Back Pain
- Being tested
- Intracept Treatment, Sham Treatment
- Keywords
- chronic axial low back pain, vertebrogenic pain, Radio frequency ablation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracept TreatmentDevice
Percutaneous transpedicular RF ablation of an intraosseous nerve within the lumbar vertebral body to treat chronic axial low back.
Sham TreatmentDevice
Percutaneous transpedicular access to the lumbar vertebra, no RF ablation delivered.
| Study group | Role | What they receive |
|---|---|---|
| Intracept Treatment | Experimental | Not described Receives: Device: Intracept Treatment |
| Sham Treatment | Sham comparator | Not described Receives: Device: Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ODI From Baseline to 3 Months Post-treatment
The primary variable is the Oswestry Disability Index (ODI) and the primary efficacy endpoint is the mean improvement from baseline to 3 months in the ODI. The primary endpoint will be evaluated in both the treatment and sham groups with between-group comparisons used to assess the success of the Intracept System in reducing chronic axial low back pain.
ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms.
Measured: 3 months
Secondary outcomes (2)
Patient Success at 3 Months
Proportion of subjects with clinical success at 3 months, where clinical success was defined as:
- 3 month ODI score represented at least a 15-point reduction from baseline
- no device or procedure related SAE between baseline and 3 mos.
- no increase in opioid use between procedure and 3 mos.
- no deficit in a motor or dermatomal sensory group at the treated level at 3 mos.
- no operative interventions or invasive procedures for lumbar back pain by a pain management or spinal specialist between procedure and 3 mos.
Measured: 3 months
Change in ODI From Baseline to 6 Months Post-treatment
The improvement in ODI at 6 months compared to baseline.
ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2015
- Study completionMar 2016
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 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Relievant Medsystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Fischgrund, MD, Principal investigator, Michigan Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446419
- Sponsor's protocol ID
- CIP 0003
- Acronym
- SMART
- Status last verified
- Oct 2016
- First submitted
- 3 Oct 2011
- Last updated
- 31 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized, Double-blind, Controlled Investigation Evaluating the Intracept Intraosseous Nerve Ablation System for the Reduction of Pain in Patients With Chronic Axial Low Back Pain
- ClinicalTrials.gov ID
- NCT01446419
- Acronym / sponsor ID
- SMART / CIP 0003
- Conditions
- Low Back Pain
- Keywords
- chronic axial low back pain, vertebrogenic pain, Radio frequency ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Relievant Medsystems, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Posted 31 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of RF ablation using the Intracept Intraosseous Nerve Ablation System to ablate intraosseous nerves for the relief of chronic axial low back pain. This is a prospective, double-blind, randomized, sham-controlled clinical trial with an optional crossover component.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracept Treatment | Experimental | Device: Intracept Treatment |
| Sham Treatment | Sham comparator | Device: Sham Treatment |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Skeletally mature patients age 25 - 70 years, inclusive
- Chronic lower back pain for at least six (6) months
- Failure to respond to at least six (6) months of non-operative conservative management. The minimum requirement is as follows:
- Oswestry Disability Index (ODI) at time of evaluation of at least 30 points
- Baseline Visual Analog Scale (VAS) of at least 4cm on a 10cm scale
Key exclusion criteria (36 listed)
- Radicular pain by history or evidence of pain or neurological deficit in a dermatomal zone at or below the medial thigh.
- Previous surgery performed on the lumbar spine
- History of symptomatic spinal stenosis
- History of osteoporotic or tumor-related vertebral body compression fracture
- 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 TreatmentPercutaneous transpedicular RF ablation of an intraosseous nerve within the lumbar vertebral body to treat chronic axial low back. | Device | Intracept Treatment |
| Sham TreatmentPercutaneous transpedicular access to the lumbar vertebra, no RF ablation delivered. | Device | Sham Treatment |
Primary outcome
Change in ODI From Baseline to 3 Months Post-treatment
Time frame: 3 months
The primary variable is the Oswestry Disability Index (ODI) and the primary efficacy endpoint is the mean improvement from baseline to 3 months in the ODI. The primary endpoint will be evaluated in both the treatment and sham groups with between-group comparisons used to assess the success of the Intracept System in reducing chronic axial low back pain. ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms.
2 secondary outcomes
Patient Success at 3 Months
Time frame: 3 months
Change in ODI From Baseline to 6 Months Post-treatment
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeffrey Fischgrund, MD principal investigator
Michigan Orthopaedic Institute
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracept Treatment in people with 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 11 inclusion and 36 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 31 Oct 2016. 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. Some participants in this study may receive a placebo. 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 31 Oct 2016). 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?
Change in ODI From Baseline to 3 Months Post-treatment (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 31 Oct 2016.