Facet Related Low Back PainNCT03321344
Safety and Initial Feasibility of Using the Neurolyser for Facet Related Low Back Pain
A study testing Focused Ultrasound Thermal ablation in people with Facet Related Low Back Pain, run by FUSMobile Inc. at 1 site in Canada.
Trial summary
Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a new portable high intensity focused ultrasound device, for noninvasive thermal ablation of medial nerve branches of painful lumbar facet joint/s Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Facet Related Low Back Pain
- What is being tested?
- Focused Ultrasound Thermal ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 5 Dec 2017to 19 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and females, legally able and willing to participate in the study and come for follow-up visits
- Able and willing to fill the study forms and to communicate with investigator
- Patient with uni or bilateral lumbar facetogenic pain of > 6 months duration
- Patients presenting with a) a positive (>70% pain relief) to a previous L1 to L5 lumbar medial branch block and / or b) with a positive (>70% pain relief) to a previous lumbar facet thermal RF denervation within the last 6 months)
- Average pain score of 4 or higher in the last month, (on a scale of 0 to 10)
Who cannot join
- Pregnant or breastfeeding patient
- Patients younger than 18 or older than 80 years
- Patients presenting with neurological deficits (including lumbosacral radiculopathy but not radicular pain).
- History of spine surgery
- Presence of metal hardware at the lumbosacral spine
- 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)
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- Patients unable to understand and complete the research questionnaires in English or French
- Any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome.
- Patient with extensive scarring in 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Alan Edwards Pain Management Unit - Montreal General Hospital
Montreal, Quebec, H3G 1A4
About this study
Official title: Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Facet Related Low Back Pain
Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a new portable high intensity focused ultrasound device, for noninvasive thermal ablation of medial nerve branches of painful lumbar facet joint/s
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 McGill University.
Study population: Ten adult patients diagnosed with facet related low back pain.
Primary study objective: Safety and efficacy of the Neurolyser XR for the treatment of facet related low back pain.
Safety would be evaluated by the incidence and severity of treatment related adverse events Efficacy would be evaluated by the changes in average pain score and Rolland Morris Disability Questionnaire between baseline and 6 months.
- Conditions
- Facet Related Low Back Pain
- Being tested
- Focused Ultrasound Thermal ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused Ultrasound Thermal ablationDevice
Focused Ultrasound Thermal ablation of the Medial Nerve Branch
| Study group | Role | What they receive |
|---|---|---|
| Test Arm | Experimental | Focused Ultrasound Thermal ablation of the Medial Nerve Branch Receives: Device: Focused Ultrasound Thermal ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS
Reduction in average pain score as measured by a numeric rating scale from 0 (no pain) to 10, worst possible pain
Measured: Base line, 2 days 1, 2 & 4 weeks, 3, 6 & 12 months after procedure
RMD
Reduction in Rolland Morris Disability Questionnaire score
Measured: Base line, 1 & 4 weeks, 3, 6 & 12 months after procedure
Saftey
Safety will be measured by the incidence and severity of treatment related adverse events
Measured: Base line, Procedure day, 2 days 1, 2 & 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 posted25 Oct 2017
- Study start5 Dec 2017
- Primary completion28 Feb 2019
- Study completion19 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Facet Related 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
- 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
- Focused Ultrasound Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321344
- Sponsor's protocol ID
- LBP-001
- Status last verified
- Jul 2020
- First submitted
- 18 Oct 2017
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perez J, Gofeld M, Leblang S, Hananel A, Aginsky R, Chen J, Aubry JF, Shir Y. Fluoroscopy-Guided High-Intensity Focused Ultrasound Neurotomy of the Lumbar Zygapophyseal Joints: A Clinical Pilot Study. Pain Med. 2022 Jan 3;23(1):67-75. doi: 10.1093/pm/pnab275.
PubMed 34534337
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. 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 Facet Related Low Back Pain
- ClinicalTrials.gov ID
- NCT03321344
- Acronym / sponsor ID
- LBP-001
- Conditions
- Facet Related Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- FUSMobile Inc.Industry (pharma, biotech, devices)
- Collaborators
- Focused Ultrasound Foundation
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 19 Feb 2020 (actual)
- First posted
- 25 Oct 2017 (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 new portable high intensity focused ultrasound device, for noninvasive thermal ablation of medial nerve branches of painful lumbar facet joint/s
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 McGill University.
Study population: Ten adult patients diagnosed with facet related low back pain.
Primary study objective: Safety and efficacy of the Neurolyser XR for the treatment of facet related low back pain.
Safety would be evaluated by the incidence and severity of treatment related adverse events Efficacy would be evaluated by the changes in average pain score and Rolland Morris Disability Questionnaire 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 |
|---|---|---|
| Test Arm | Experimental | Device: Focused Ultrasound Thermal ablationFocused Ultrasound Thermal ablation of the Medial Nerve Branch |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult male and females, legally able and willing to participate in the study and come for follow-up visits
- Able and willing to fill the study forms and to communicate with investigator
- Patient with uni or bilateral lumbar facetogenic pain of > 6 months duration
- Patients presenting with a) a positive (>70% pain relief) to a previous L1 to L5 lumbar medial branch block and / or b) with a positive (>70% pain relief) to a previous lumbar facet thermal RF denervation within the last 6 months)
- Average pain score of 4 or higher in the last month, (on a scale of 0 to 10)
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding patient
- Patients younger than 18 or older than 80 years
- Patients presenting with neurological deficits (including lumbosacral radiculopathy but not radicular pain).
- History of spine surgery
- Presence of metal hardware at the lumbosacral spine
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 |
|---|---|---|
| Focused Ultrasound Thermal ablationFocused Ultrasound Thermal ablation of the Medial Nerve Branch | Device | Test Arm |
Primary outcome
NRS
Time frame: Base line, 2 days 1, 2 & 4 weeks, 3, 6 & 12 months after procedure
Reduction in average pain score as measured by a numeric rating scale from 0 (no pain) to 10, worst possible pain
RMD
Time frame: Base line, 1 & 4 weeks, 3, 6 & 12 months after procedure
Reduction in Rolland Morris Disability Questionnaire score
Saftey
Time frame: Base line, Procedure day, 2 days 1, 2 & 4 weeks, 3, 6 & 12 months after procedure
Safety will be measured by the incidence and severity of treatment related adverse events
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 25 Jan 2021.
- Derived from this study: PubMed 34534337Perez J, Gofeld M, Leblang S, Hananel A, Aginsky R, Chen J, Aubry JF, Shir Y. Fluoroscopy-Guided High-Intensity Focused Ultrasound Neurotomy of the Lumbar Zygapophyseal Joints: A Clinical Pilot Study. Pain Med. 2022 Jan 3;23(1):67-75. doi: 10.1093/pm/pnab275.
- Individual participant dataSharing planned: No
Related trials for Facet Related Low Back Pain
RecruitingObservational study
Association of Subcutaneous Fat Index, Paraspinal Muscle Characteristics, and Facet Morphology With Lumbar Facet Joint Degeneration
Chronic Low Back Pain, Lumbar Facet Joint Degeneration
Not yet recruitingObservational study
Association Between Trendelenburg Sign and Lumbar MRI Abnormalities
Facet Joint Arthropathy, Lower Back Pain
Not yet recruitingObservational study
The Relation of the Anatomic Morphology of Lumbar Transverse Processes and the Success Rate of Facet Joint Radiofrequency Denervation
Lower Back Pain Chronic
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 Focused Ultrasound Thermal ablation in people with Facet Related Low Back Pain, run by FUSMobile Inc. at 1 site in Canada.
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 10 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 25 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 1 site in Canada. 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?
NRS (time frame: Base line, 2 days 1, 2 & 4 weeks, 3, 6 & 12 months after procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03321344, which also lists 1 linked publication.
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 25 Jan 2021.