CompletedNot Applicable

Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain

United States90 participantsStarted 2022-05-16

Plain-language summary

Double arm pivotal study to evaluate the Neurolyser XR as a non-invasive treatment of axial chronic low back pain

Age range50 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age 50 to 85 years old, legally able and willing to participate in the study and all follow-up visits
✓. Able and willing to complete the research questionnaires and to communicate with investigator and research team
✓. Individual with current bilateral or unilateral low back pain of \> 6 months duration
✓. Individual whose back pain is alleviated by recumbency or comfortable sitting position
✓. Individual presenting with a) a positive (\>80% pain relief) to a previous, double, lumbar medial branch block (within the last 12 months) and/or b) with a positive (\>70% pain relief lasting more than 6 months) to the most recent lumbar facet thermal radiofrequency denervation
✓. Average low back pain score of 6 or higher in the last month (on 0-10 scale) with activity

✕. Individuals who are pregnant or breastfeeding
✕. Individuals younger than 50 or older than 85 years
✕. BMI greater than 40, or individuals with at least one of the planned targets outside the Neurolyser XR treatment envelope as seen on treatment day on a lateral X-ray scan taken before the treatment.
✕. Individuals presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain)
✕. Individuals with history of lumbar or lumbosacral spine surgery
✕. Individuals who have had lumbar radiofrequency neurotomy in the past 6 months
✕. Individuals with history of lumbar spine pathology that may increase procedural risk and/or influence symptoms and/or generate unrelated adverse event (per investigator's discretion)
✕. Individuals presenting with any severe medical condition preventing them from participation (per investigator's discretion) (Example: inability to lay prone)

NRS

Timeframe: Base line, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure

Procedure and Device Safety up to six months post procedure

Timeframe: 6 months after procedure

NCT IDNCT05154448

SponsorFUSMobile Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-16

Who can participate

Age range50 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age 50 to 85 years old, legally able and willing to participate in the study and all follow-up visits
✓. Able and willing to complete the research questionnaires and to communicate with investigator and research team
✓. Individual with current bilateral or unilateral low back pain of \> 6 months duration
✓. Individual whose back pain is alleviated by recumbency or comfortable sitting position
✓. Individual presenting with a) a positive (\>80% pain relief) to a previous, double, lumbar medial branch block (within the last 12 months) and/or b) with a positive (\>70% pain relief lasting more than 6 months) to the most recent lumbar facet thermal radiofrequency denervation
✓. Average low back pain score of 6 or higher in the last month (on 0-10 scale) with activity

✕. Individuals who are pregnant or breastfeeding
✕. Individuals younger than 50 or older than 85 years
✕. BMI greater than 40, or individuals with at least one of the planned targets outside the Neurolyser XR treatment envelope as seen on treatment day on a lateral X-ray scan taken before the treatment.
✕. Individuals presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain)
✕. Individuals with history of lumbar or lumbosacral spine surgery
✕. Individuals who have had lumbar radiofrequency neurotomy in the past 6 months
✕. Individuals with history of lumbar spine pathology that may increase procedural risk and/or influence symptoms and/or generate unrelated adverse event (per investigator's discretion)
✕. Individuals presenting with any severe medical condition preventing them from participation (per investigator's discretion) (Example: inability to lay prone)