A Multi-Center Randomized Clinical Study of the NOCISCAN MR Spectroscopy (MRS) in Patients Treated for Discogenic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aclarion
- 入组人数
- 300
- 试验地点
- 11
- 主要终点
- Change in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment
研究概览
简要总结
This study is looking into how useful NOCISCAN is. NOCISCAN is a software as a Service (SaaS) tool that uses Magnetic Resonance (MR) spectroscopy. Nociscan 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is a skeletally mature male or female (non-pregnant) aged 18 to 70 years (inclusive);
- •Subject intends to undergo instrumented surgical treatment in the lumbar spinal disc for their lower back pain, independent of this research protocol;
- •Subject is to be treated with FDA-cleared or FDA-approved devices independent of this research protocol;
- •Subject has a preoperative Oswestry Disability Questionnaire score ≥35 out of 100 points (35/100);
- •Subject has a VAS back pain score of ≥40mm;
- •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.
排除标准
- •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);
- •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:
- •Grade 3 Spondylolisthesis (Grade 1 or Grade 2 is allowed)
- •Pars fracture, at the involved level
- •Spondylolysis
- •Lumbar scoliosis with a Cobb angle of greater than 20°
- •Evidence of prior fracture or trauma to the L1, L2, L3, L4, or L5 levels in either compression or burst
- •Lumbar kyphosis
- •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 has a chronic disease (other than degenerative disc disease), chronic pain (other than 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
研究组 & 干预措施
Unblinded-to-NOCISCAN
NOCISCAN completed pre-operatively. Investigator will have access to the NOCISCAN result after completing initial treatment plan but before treatment.
干预措施: Fusion or TDR determined by investigator. (Procedure)
Blinded-to-NOCISCAN
NOCISCAN completed pre-operatively. Investigator will not have access to NOCISCAN result.
干预措施: Fusion or TDR determined by investigator. (Procedure)
结局指标
主要结局
Change in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment
时间窗: Baseline to 12 months
The primary endpoint is change in back pain as measured on a 100mm VAS Back at 12 months compared to baseline. VAS is a measurement instrument that measures the amount of pain that a subject feels ranges across a continuum from none to an extreme amount of pain. Higher scores closer to the extreme pain range indicate worse outcome.
次要结局
- Patient-Reported Outcome Measurement Information System (PROMIS) 29 score(Each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months))
- Absence of Secondary surgical intervention(From Baseline through study completion, 24-Months)
- 20 mm improvement in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment(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(From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months))
- Patient reported treatment satisfaction survey(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)(From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months))
- Correlation of preoperative NOCISCAN Biomarkers with preoperative Visual Analog Scale (VAS) Pain Assessment Scores(From Baseline through study completion, 24-Months)