Facet Syndrome of Lumbar SpineNCT04519541
RAMBAM 021: Safety and Initial Feasibility of the Neurolyser XR for the Treatment of Chronic Low Back Pain
A study testing Non-Invasive Thermal Ablation of the Medial Branch Nerves using the Neurolyser XR in people with Facet Syndrome of Lumbar Spine, run by FUSMobile Inc. at 1 site in Israel.
Trial summary
Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a high intensity focused ultrasound device, for non-invasive treatment of axial chronic low back pain Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Facet Syndrome of Lumbar Spine
- What is being tested?
- Non-Invasive Thermal Ablation of the Medial Branch Nerves using the Neurolyser XR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 3 Feb 2021to 31 Jan 2023
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and females >55 years of age legally able and willing to participate in the study and come for follow-up visits Able and willing to fill the research questionnaires and to communicate with investigator and research team Patient with bilateral or unilateral low back pain of > 6 months duration Patients whose back pain is alleviated by recumbency or comfortable sitting position Patients presenting with a) a positive (>70% pain relief) to a previous, single or double, L1 to L5 lumbar medial branch block (within the last 12 months) and / or b) with a positive (>70% pain relief lasting more than 6 months) to a previous lumbar facet thermal radiofrequency denervation.
- Average pain score of 6 or higher in the last month, (on 0-10 scale).
Who cannot join
- Pregnant or breastfeeding patient Patients younger than 55 or older than 85 years Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).
- Patients with history of lumbosacral spine surgery excluding previous lumbar radiofrequency neurotomy Patients who have had lumbar radiofrequency neurotomy in the past 6 months Patients with the presence of metal hardware or other foreign objects at the lumbosacral spine Patients with history of lumbar spine pathology that may increase procedural risk and / or influence symptoms and / or generate unrelated adverse event, (per the discretion of the study PI) Patients unable to understand and complete the research questionnaires in the official language used within the particular sites' location.
- Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome per PI decision.
- Patient with extensive scarring of the skin and tissue overlying the treatment area.
- Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project Any patients with an uncontrolled coagulopathy Patients with known osteoporosis with absolute risk of spinal fracture of >10% over 10 years will be excluded Any patients with a history of malignant disease in the past five years Patients with rheumatologic diseases causing spine pain that are currently receiving active treatment including steroids, disease modifying drugs, biological agents or immunosuppressants.
- Patients known for concomitant psychiatric disorders, excluding mood disorders. Patients presenting with concomitant mood disorders (deemed severe by the research physician).
- Patients with a first-degree family member already enrolled in this study. Patient who is scheduled for any interventional/surgical procedure within 3 months from screening date Patients diagnosed with co-morbid multifocal chronic pain (e.g., fibromyalgia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain
Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a high intensity focused ultrasound device, for non-invasive treatment of axial chronic low back pain
Read the detailed description
Study design: Prospective, single arm
Timeline: six month enrollment period and 12 months follow-up period.
Sites: The study will be conducted at five sites in Canada: McGill University, Toronto Western, Silver Medical Group, Precision Sport \& Spine, Kinetix Integrated Orthopaedic \& Regenerative Medicine
Study population: Thirty adult patients diagnosed with facet related low back pain.
Primary study objective: Safety and efficacy of the Neurolyser XR for the treatment of chronic low back pain secondary to zygapophyseal joint syndrome.
Safety is measured by the incidence and severity of treatment related adverse events.
Efficacy is measured by the changes in pain severity at the treatment area, using a numerical rating scale (NRS), of 0 to 10 between baseline and 6 months.
- Conditions
- Facet Syndrome of Lumbar Spine
- Being tested
- Non-Invasive Thermal Ablation of the Medial Branch Nerves using the Neurolyser XR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Thermal Ablation of the Medial Branch Nerves using the Neurolyser XRDevice
Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Neurolyser XR treatment | Experimental | Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound Receives: Device: Non-Invasive Thermal Ablation of the Medial Branch Nerves using the Neurolyser XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale of pain (NRS)
Change in average pain score as measured by a numeric rating scale from 0 (no pain) to 10, worst possible pain
Measured: Time Frame: Base line, 2 days 1, 2 & 4 weeks, 3, 6 & 12 months after procedure
Saftey
Procedure and Device Safety at six months as measured by measured by the number and severity of treatment related adverse events
Measured: Time Frame: 6 months after procedure
Secondary outcomes (4)
Lesion Size
Lesion size and location as shown in MRI Image, 2 days post treatment.
Measured: 2 days post procedure
Oswestry Disability Index (ODI)
Low Back Pain Questionnaire (Range: 0% to 100%)
Measured: Time Frame: Base line, 1, & 4 weeks, 3, 6 & 12 months after procedure
Short Form 12 (SF-12)
A multipurpose short form survey with 12 questions (Range: 0 to 100)
Measured: Time Frame: Base line, 1, & 4 weeks, 3, 6 & 12 months after procedure
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (Range: 1 to 7)
Measured: Time Frame: 1, & 4 weeks, 3, 6 & 12 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start3 Feb 2021
- Primary completion11 Sep 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facet Syndrome of Lumbar SpineStudies 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
- Model description
- Single arm, non-randomized
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- FUSMobile Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rambam Health Care Campus
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519541
- Sponsor's protocol ID
- LBP-021-RAMBAM
- Status last verified
- Jan 2023
- First submitted
- 17 Aug 2020
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04519541
- Acronym / sponsor ID
- LBP-021-RAMBAM
- Conditions
- Facet Syndrome of Lumbar Spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- FUSMobile Inc.Industry (pharma, biotech, devices)
- Collaborators
- Rambam Health Care Campus
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 11 Sep 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 19 Aug 2020 (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.
Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a high intensity focused ultrasound device, for non-invasive treatment of axial chronic low back pain
Detailed description
Study design: Prospective, single arm
Timeline: six month enrollment period and 12 months follow-up period.
Sites: The study will be conducted at five sites in Canada: McGill University, Toronto Western, Silver Medical Group, Precision Sport \& Spine, Kinetix Integrated Orthopaedic \& Regenerative Medicine
Study population: Thirty adult patients diagnosed with facet related low back pain.
Primary study objective: Safety and efficacy of the Neurolyser XR for the treatment of chronic low back pain secondary to zygapophyseal joint syndrome.
Safety is measured by the incidence and severity of treatment related adverse events.
Efficacy is measured by the changes in pain severity at the treatment area, using a numerical rating scale (NRS), of 0 to 10 between baseline and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, non-randomized
| Arm | Type | Receives |
|---|---|---|
| Neurolyser XR treatment | Experimental | Device: Non-Invasive Thermal Ablation of the Medial Branch Nerves using the Neurolyser XRThermal ablation of the medial nerve branch using High Intensity Focused Ultrasound |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult male and females >55 years of age legally able and willing to participate in the study and come for follow-up visits Able and willing to fill the research questionnaires and to communicate with investigator and research team Patient with bilateral or unilateral low back pain of > 6 months duration Patients whose back pain is alleviated by recumbency or comfortable sitting position Patients presenting with a) a positive (>70% pain relief) to a previous, single or double, L1 to L5 lumbar medial branch block (within the last 12 months) and / or b) with a positive (>70% pain relief lasting more than 6 months) to a previous lumbar facet thermal radiofrequency denervation.
- Average pain score of 6 or higher in the last month, (on 0-10 scale).
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding patient Patients younger than 55 or older than 85 years Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).
- Patients with history of lumbosacral spine surgery excluding previous lumbar radiofrequency neurotomy Patients who have had lumbar radiofrequency neurotomy in the past 6 months Patients with the presence of metal hardware or other foreign objects at the lumbosacral spine Patients with history of lumbar spine pathology that may increase procedural risk and / or influence symptoms and / or generate unrelated adverse event, (per the discretion of the study PI) Patients unable to understand and complete the research questionnaires in the official language used within the particular sites' location.
- Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome per PI decision.
- Patient with extensive scarring of the skin and tissue overlying the treatment area.
- Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project Any patients with an uncontrolled coagulopathy Patients with known osteoporosis with absolute risk of spinal fracture of >10% over 10 years will be excluded Any patients with a history of malignant disease in the past five years Patients with rheumatologic diseases causing spine pain that are currently receiving active treatment including steroids, disease modifying drugs, biological agents or immunosuppressants.
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 |
|---|---|---|
| Non-Invasive Thermal Ablation of the Medial Branch Nerves using the Neurolyser XRThermal ablation of the medial nerve branch using High Intensity Focused Ultrasound | Device | Neurolyser XR treatment |
Primary outcome
Numerical rating scale of pain (NRS)
Time frame: Time Frame: Base line, 2 days 1, 2 & 4 weeks, 3, 6 & 12 months after procedure
Change in average pain score as measured by a numeric rating scale from 0 (no pain) to 10, worst possible pain
Saftey
Time frame: Time Frame: 6 months after procedure
Procedure and Device Safety at six months as measured by measured by the number and severity of treatment related adverse events
4 secondary outcomes
Lesion Size
Time frame: 2 days post procedure
Oswestry Disability Index (ODI)
Time frame: Time Frame: Base line, 1, & 4 weeks, 3, 6 & 12 months after procedure
Short Form 12 (SF-12)
Time frame: Time Frame: Base line, 1, & 4 weeks, 3, 6 & 12 months after procedure
Patient Global Impression of Change (PGIC)
Time frame: Time Frame: 1, & 4 weeks, 3, 6 & 12 months after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Facet Syndrome of Lumbar Spine
Not yet recruiting
Lumbar Facet Platelet-Rich Plasma Injection Versus Medial Branch Radiofrequency Ablation for Chronic Lumbar Facet-Mediated Pain
Chronic Lower Back Pain (CLBP), Lumbar Facet Joint 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Invasive Thermal Ablation of the Medial Branch Nerves using the Neurolyser XR in people with Facet Syndrome of Lumbar Spine, run by FUSMobile Inc. at 1 site in Israel.
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 7 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 7 Sep 2023. 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 Israel. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Numerical rating scale of pain (NRS) (time frame: Time Frame: Base line, 2 days 1, 2 & 4 weeks, 3, 6 & 12 months after procedure). The study lists 2 primary outcomes in all. 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 7 Sep 2023.