Last updated: November 28, 2022
Sponsor: FUSMobile Inc.
Overall Status: Active - Not Recruiting
Phase
N/A
Condition
Chronic Pain
Treatment
N/AClinical Study ID
NCT04129034
LBP-002
Ages 55-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Adult male and females >55 years of age legally able and willing to participate in thestudy and come for follow-up visits
- Able and willing to fill the research questionnaires and to communicate withinvestigator 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 ordouble, 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 lumbarfacet thermal radiofrequency denervation.
- Average pain score of 6 or higher in the last month, (on 0-10 scale).
Exclusion
Exclusion Criteria:
- Pregnant or breastfeeding patient
- Patients younger than 55 or older than 85 years
- Patients presenting with neurological deficits (including lumbosacral radiculopathybut not solitary radicular pain).
- Patients with history of lumbosacral spine surgery excluding previous lumbarradiofrequency 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 thelumbosacral 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 discretionof the study PI)
- Patients unable to understand and complete the research questionnaires in the officiallanguage used within the particular sites' location.
- Patients presenting with any severe medical condition preventing the patient fromsafely and effectively being treated in the study or reporting study outcome per PIdecision.
- 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 theduration of this research project
- Any patients with an uncontrolled coagulopathy
- Patients with known osteoporosis with absolute risk of spinal fracture of >10% over 10years 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 receivingactive treatment including steroids, disease modifying drugs, biological agents orimmunosuppressants.
- Patients known for concomitant psychiatric disorders, excluding mood disorders.
- Patients presenting with concomitant mood disorders (deemed severe by the researchphysician).
- Patients with a first-degree family member already enrolled in this study.
- Patient who is scheduled for any interventional/surgical procedure within 3 monthsfrom screening date
- Patients diagnosed with co-morbid multifocal chronic pain (e.g., fibromyalgia)
Study Design
Total Participants: 30
Study Start date:
September 24, 2019
Estimated Completion Date:
March 26, 2023
Study Description
Connect with a study center
Kinetix Medicine
Vancouver, British Columbia BC V6K 2E4
CanadaSite Not Available
Precision Sport & Spine
Oakville, Ontario L6L 1H5
CanadaSite Not Available
Silver Medical Group
Toronto, Ontario M3H 5S4
CanadaSite Not Available
Toronto Western
Toronto, Ontario M5T 2S8
CanadaSite Not Available
Alan Edwards Pain Management Unit - Montreal General Hospital
Montréal, Quebec H3G 1A4
CanadaSite Not Available
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