Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes

Официальное название

A Multi-Center Randomized Clinical Study of the NOCISCAN MR Spectroscopy (MRS) in Patients Treated for Discogenic Low Back Pain

Обзор

This study is looking into how safe and useful NOCISCAN is. NOCISCAN is a software as a Service (SaaS) tool that uses Magnetic Resonance (MR) spectroscopy. Nociscan (instead of 'It') leverages MRS to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. The randomized controlled trial will compare the blinded and unblinded cohorts and their corresponding surgical outcomes with the Nocigram reports, generated prior to treatment, for each patient."

Вмешательства

• Процедура Fusion or TDR determined by investigator.
  The surgical treatment will be decided by the treating investigator based on their clinical judgement.

Первичные конечные точки

• Change in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment [Срок оценки: Baseline to 12 months]

Вторичные конечные точки (7)

• 20 mm improvement in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment [Срок оценки: From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)]
• 20 mm improvement in worst leg pain on a 100mm Visual Analog Scale (VAS) Pain Assessment [Срок оценки: From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)]
• Patient reported treatment satisfaction survey [Срок оценки: Each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)]
• Patient-Reported Outcome Measurement Information System (PROMIS) 29 score [Срок оценки: Each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)]
• Cumulative proportion of responders (CPRA) for 15 point Oswestry Disability Index (ODI) change (out of 100) [Срок оценки: From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)]
• Absence of Secondary surgical intervention [Срок оценки: From Baseline through study completion, 24-Months]
• Correlation of preoperative NOCISCAN Biomarkers with preoperative Visual Analog Scale (VAS) Pain Assessment Scores [Срок оценки: From Baseline through study completion, 24-Months]

Критерии участия

Критерии включения

• Subject is a skeletally mature male or female (non-pregnant) aged 18 to 70 years (inclusive);
• Subject plans to undergo surgical treatment of their discogenic back pain independent of this research protocol;
• Subject is to be treated with on-label use of FDA-cleared or FDA-approved devices independent of this research protocol;
• Subject has a diagnosis of discogenic back pain that requires treatment in up to two lumbar levels caused by degenerative disc disease (identified via MRI);
• Subject has a preoperative Oswestry Disability Questionnaire score ≥35 out of 100 points (35/100);
• Subject has a VAS back pain score of ≥40mm and that is greater than the worst VAS leg pain score;
• Subject has failed at least ≥ 6 months of non-operative treatment (for example: physical therapy, bed rest, anti-inflammatory or analgesic medications, chiropractic care, acupuncture, massage therapy or home-directed lumbar exercise programs) OR requires urgent surgical treatment per the investigator;
• Subject has signed the IRB approved Informed Consent Form; and
• Subject is psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.

Критерии исключения

• Subject has a primary diagnosis of spinal condition other than degenerative disc disease at the involved level (i.e., facet joint pain/SI pain);
• Subject has had prior lumbar back surgery or intradiscal treatments at any lumbar level (Note: diagnostic provocative or anesthetic discography are not excluded; micro-discectomy, decompression, or laminectomy patients greater than 6 months postop are not excluded);
• Surgery is planned for more than 2 lumbar levels.
• Subject has severe spinal canal stenosis as assessed by the Investigator;
• Subject has a motor strength deficit(s) in lower extremities
• Subject has a lumbar spine diagnosis, based on radiographic evidence, of clinically relevant lumbar vertebral abnormalities (except Modic end-plate changes, which are not excluded), including:

• Spondylolisthesis Grade 2 or greater (up to Grade 1 is accepted)
• Pars fracture, at the involved level
• Spondylolysis
• Lumbar scoliosis with a Cobb angle of greater than 15°
• Evidence of prior fracture or trauma to the L1, L2, L3, L4, or L5 levels in either compression or burst
• Lumbar kyphosis
• Subject has radiologic evidence of an uncontained lumbar disc herniation or lumbar disc extrusion.
• Subject is contraindicated for a standard lumbar MRI exam
• Women who are currently pregnant (or believe they may be at risk of being or becoming pregnant), or are breast feeding, during the study period when scans will be performed
• Subject is currently receiving worker's compensation or is involved in in any litigation for personal injury, medical negligence, trauma, or worker's compensation.
• Subject has a chronic disease (other than degenerative disc disease), chronic pain (other than discogenic low back pain), or psychological dysfunction, which may, in the opinion of the Principal Investigator, compromise a subject's ability to comply with study procedures, and/or may confound data
• Subject has a BMI > 40

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 9 центров

• Todd H. Lanman, M.D Inc — Beverly Hills
• Scripps Health — La Jolla
• USC Keck Medical Center — Los Angeles
• University of Miami/ Jackson Health System — Miami
• Northwestern University — Chicago
• Endeavor Health — Evanston
• Advocate Aurora Research Institute — Park Ridge
• Johns Hopkins Medicine — Baltimore
• … и ещё 1 центр

Идентификаторы

NCT: NCT06661850 · Clarity

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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