Lumbar Facet Joint PainNCT02291978
MR Guided High Intensity Focused Ultrasound for Lumbar Back Pain
A study testing ExAblate 2100 in people with Lumbar Facet Joint Pain, run by Stanford University at 1 site in United States.
Trial summary
The primary purpose of this protocol is to assess the ExAblate 2100 MR guided high intensity focused ultrasound device as an intervention for treatment of facetogenic lower back pain. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lumbar Facet Joint Pain
- What is being tested?
- ExAblate 2100
- 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
- Oct 2014to 20 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women > 21 years of age and who are skeletally mature
- Body mass index ≤ 30 kg/m2
- Patients who are able to understand and willing to sign a written informed consent document and able to attend all study visits
- Patients with at least 6 months of chronic lower back pain (LBP) localized to the midline or axial low back, with symptoms attributed to the facet joints on physical examination that have persisted despite conservative therapy. Conservative therapy is defined as systemic pain medications and anti-inflammatory medications, as well as physical therapy, such as massage, heating, hydrotherapy, and strengthening exercises.
- Patients with Numerical Rating Scale worst lumbar back pain score of at least 4 out of 10 over the 24 hours preceding the time of rating.
- Patients must have chronic LBP attributed to facet joints as demonstrated by MRI consistent with at least grade 2 facet joint arthritis, with corresponding abnormal activity at the facet joint on 18F-sodium fluoride PET-CT.
- Patients must have an analgesic response to either prior local anesthetic injection to the facet joint or to radiofrequency ablation of the facet joint, with relapse of pain.
- The targeted facet joint must be deeper than 10 mm from the skin
Who cannot join
- Patients with severe lumbar lordosis
- Patients with contraindication for MR imaging such as implanted metallic devices that are not MRI-safe, size limitations, claustrophobia. etc
- Patients with known intolerance or allergy to MR contrast agent (gadolinium chelates) including advanced kidney disease (GFR <30 mL/min/1.73 m2) or on dialysis
- Pregnant and nursing patients will be excluded from the study because of a contraindication to administering MRI contrast agents to these patients
- Patients with known intolerance or allergy to medications used for sedation (midazolam), analgesia (fentanyl), and local and regional anesthesia (lidocaine, bupivacaine, and ropivacaine)
- Patients with evidence of lumbosacral radiculopathy on MRI or physical exam findings, including radicular leg pain, or any neurologic deficit at or below the segmental level of the highest facet to be treated, including subjects with impaired sphincter control
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- Patients with pain at another location that
- cannot be distinguished from lumbar back pain
- does not rate at least 2 points less in worst pain score compared to lumbar back pain
- requires the use of analgesics
- Patients with gross spinal instability on imaging
- Patients who have lumbar spinal stabilization hardware in place
- Target is:
- NOT visible by non-contrast MRI, OR
- NOT accessible to ExAblate device
- Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 5 hrs of total table time)
- Patients with acute medical condition (e.g. pneumonia, sepsis) that is expected to hinder them from completing this study
- Patients with unstable cardiac status including:
- Unstable angina pectoris on medication
- Patients with documented myocardial infarction within six months of protocol entry
- Congestive heart failure requiring medication (other than diuretic)
- Patients on anti-arrhythmic drugs
- Patients with severe hypertension (diastolic BP > 100 on medication)
- Patients with severe hematologic, neurologic, or other uncontrolled disease (e.g. platelets < 50,000/microL, INR > 1.5)
- Patients who are taking anti-thrombotic medication
- Severe cerebrovascular disease (multiple CVAs or CVA within 6 months)
- Patients with inflammatory arthritides.
- Patients unable to communicate with the investigator and staff
- Patients seeking compensation for disability or work injury.
- Patients who are part of another trial testing other Investigational Agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study to Evaluate the Safety and Initial Effectiveness of MR Guided High Intensity Focused Ultrasound (MRgHIFU) in the Treatment of Facetogenic Lumbar Back Pain
The primary purpose of this protocol is to assess the ExAblate 2100 MR guided high intensity focused ultrasound device as an intervention for treatment of facetogenic lower back pain.
Read the detailed description
This is a single group, single arm, open/nonblinded, non-randomized study. The primary outcomes are safety and preliminary efficacy. The InSightec ExAblate 2100 MRgHIFU system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue and bone.The study will reach primary completion 12 months from the time the study opens to accrual.
- Conditions
- Lumbar Facet Joint Pain
- Being tested
- ExAblate 2100
- Keywords
- back pain, facet joint, spine
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate 2100Device
The InSightec ExAblate 2100 MRgHIFU system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue and bone.
| Study group | Role | What they receive |
|---|---|---|
| ExAblate 2100 Treatment | Experimental | The ExAblate 2100 system will be used in the MRgHIFU treatment of lower back pain arising from facet joint arthritis. Receives: Device: ExAblate 2100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Related Complications as a Measure of Safety
Safety will be determined by evaluating for the incidence and severity of any device related complication from the treatment day visit through 24 months after treatment.
Measured: 24 months
Secondary outcomes (2)
Pain Relief on the Visual Analog Scale
Effectiveness will be determined by the level of pain relief, as measured by the NRS, and decrease in analgesic/opiate use.
Measured: 24 months
Quality of Life Improvement
Effectiveness will be determined by improved quality of life, as measured by the Oswestry Disability Index.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startOct 2014
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
Why it stopped: No patients met eligibility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Facet Joint PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pejman Ghanouni, Stanford University
- Investigators
- Pejman Ghanouni, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291978
- Sponsor's protocol ID
- 29163
- Status last verified
- Feb 2020
- First submitted
- 5 Nov 2014
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate the Safety and Initial Effectiveness of MR Guided High Intensity Focused Ultrasound (MRgHIFU) in the Treatment of Facetogenic Lumbar Back Pain
- ClinicalTrials.gov ID
- NCT02291978
- Acronym / sponsor ID
- 29163
- Conditions
- Lumbar Facet Joint Pain
- Keywords
- back pain, facet joint, spine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients met eligibility.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 17 Nov 2014 (estimated)
- 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.
The primary purpose of this protocol is to assess the ExAblate 2100 MR guided high intensity focused ultrasound device as an intervention for treatment of facetogenic lower back pain.
Detailed description
This is a single group, single arm, open/nonblinded, non-randomized study. The primary outcomes are safety and preliminary efficacy. The InSightec ExAblate 2100 MRgHIFU system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue and bone.The study will reach primary completion 12 months from the time the study opens to accrual.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExAblate 2100 Treatment | Experimental | Device: ExAblate 2100The ExAblate 2100 system will be used in the MRgHIFU treatment of lower back pain arising from facet joint arthritis. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women > 21 years of age and who are skeletally mature
- Body mass index ≤ 30 kg/m2
- Patients who are able to understand and willing to sign a written informed consent document and able to attend all study visits
- Patients with at least 6 months of chronic lower back pain (LBP) localized to the midline or axial low back, with symptoms attributed to the facet joints on physical examination that have persisted despite conservative therapy. Conservative therapy is defined as systemic pain medications and anti-inflammatory medications, as well as physical therapy, such as massage, heating, hydrotherapy, and strengthening exercises.
- Patients with Numerical Rating Scale worst lumbar back pain score of at least 4 out of 10 over the 24 hours preceding the time of rating.
Key exclusion criteria (30 listed)
- Patients with severe lumbar lordosis
- Patients with contraindication for MR imaging such as implanted metallic devices that are not MRI-safe, size limitations, claustrophobia. etc
- Patients with known intolerance or allergy to MR contrast agent (gadolinium chelates) including advanced kidney disease (GFR <30 mL/min/1.73 m2) or on dialysis
- Pregnant and nursing patients will be excluded from the study because of a contraindication to administering MRI contrast agents to these patients
- Patients with known intolerance or allergy to medications used for sedation (midazolam), analgesia (fentanyl), and local and regional anesthesia (lidocaine, bupivacaine, and ropivacaine)
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 |
|---|---|---|
| ExAblate 2100The InSightec ExAblate 2100 MRgHIFU system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue and bone. | Device | ExAblate 2100 Treatment |
Primary outcome
Device Related Complications as a Measure of Safety
Time frame: 24 months
Safety will be determined by evaluating for the incidence and severity of any device related complication from the treatment day visit through 24 months after treatment.
2 secondary outcomes
Pain Relief on the Visual Analog Scale
Time frame: 24 months
Quality of Life Improvement
Time frame: 24 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 24 Feb 2020.
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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.
Pejman Ghanouni, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExAblate 2100 in people with Lumbar Facet Joint Pain, run by Stanford University 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 8 inclusion and 30 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 24 Feb 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?
Device Related Complications as a Measure of Safety (time frame: 24 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 24 Feb 2020.