Clinical trial NCT04015791: NOCISCAN-Lumbar Spine (LS) Clinical Evaluation Study
Official title: Clinical Evaluation of NOCISCAN-Lumbar Spine (LS) Disc MR Spectroscopy (MRS) for Diagnosis of Discogenic Low Back Pain and Correlation With Surgical Outcomes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lumbar Disc Disease
Keywords: lumbar disc disease
MR Spectroscopy
Nociscan
Lead sponsor: Nocimed, LLC
Sponsor class: OTHER
First posted: 2019-07-11
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Up to 240 subjects that are approved and scheduled for surgery at a single level from L3 to S1 to treat chronic, severe, primary axial, discogenic, low back pain via maximum of 14 sites

Brief summary: A prospective, double blinded, multi-center study to assess the validity and clinical utility of the pre-operative NOCISCAN-LS software in the identification of painful lumbar discs, and the correlation with improved surgical outcomes at 3, 6, 12 and 24 months (follow-up) following spine surgery in a single enrollment arm of subjects with chronic symptomatic single level degenerative disc disease (DDD) at L3 to S1, but with two evaluation groups- Match Group and Miss Group,of subjects based on the association between the NOCISCORE results of treated and untreated disc levels.


Eligibility criteria: Inclusion Criteria:

1. Has history consistent with degenerative disc disease as noted by back pain of discogenic origin with or without leg pain
2. Has one of more of the following conditions as documented by CT or MRI and plain X-rays:

   1. Modic changes
   2. High intensity zones in the annulus
   3. Loss of discogenic height
   4. Decreased hydration of the disc
3. Has single level symptomatic degenerative involvement from L3 to S1 in which surgical treatment is indicated
4. Skeletally mature male or female (non-pregnant) between 18 and 70 years of age
5. Pre-operative score ≥ 40% on Oswestry Disability Index
6. VAS back pain score ≥ 40 mm and that is greater than the VAS leg pain scores
7. Patient has failed at least ≥6 months of non-operative treatment that may have included physical therapy, bed rest, anti-inflammatory or analgesic medications, chiropractic care, acupuncture, massage therapy or home-directed lumbar exercise programs
8. In subject who receives pre-operative provocative discography (PD), the PD was performed more than 6 week prior to the scheduled NOCISCAN- LS Exam OR Is scheduled to be conducted after the Nociscan exam
9. Subject is willing to sign an Institutional Review Board approved Informed Consent and HIPAA Authorization forms, and is physically and mentally able to complete study forms and otherwise willingly adhere to the requirements of the protocol in the opinion of the investigator

Exclusion Criteria:

1. Has primary diagnosis of spinal condition other than degenerative disc disease at the involved level;
2. Has had prior lumbar back surgery or intradiscal treatments at any lumbar level (Note: diagnostic provocative or anesthetic discography are not excluded; micro-discectomy +- laminectomy patients greater than 6 months postop are not excluded)
3. Surgery planned at more than one level
4. Radiographic evidence of clinically relevant lumbar vertebral abnormalities, including

   * Greater than Grade 1 spondylolisthesis according to Meyerding classification at the involved level;
   * Any posterior lumbar element insufficiency (e.g. Spondylolysis, pars fracture, or prior facet resection;
   * Lumbar scoliosis with a Cobb angle of greater than 11 degree
   * Symptomatic kyphosis or flat black syndrome
   * Evidence of prior fracture or trauma to the L1, L2,L3, L4 or L5 levels in either compression or burst; Note: Modic end plate changes will not be excluded
5. Radiographic evidence of lumbar disc herniation with extrusion
6. Clinically significant spinal canal stenosis as assessed by the Investigator
7. Any significant motor strength deficit in lower extremities
8. Suspicion of Sacro Iliac and/ or Facet joint pain as the primary pain generator;
9. Has a condition that requires post-operative medications that interfere with fusion, such as immunosuppressive drugs, steroids or prolonged use of non-steroidal anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation
10. Has active bacterial infection, either local or systemic and/or potential for bacteremia
11. Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin) during the past 5 years
12. Chronic disease (other than degenerative disc disease), chronic pain syndrome (other than discogenic low back pain), or psychological dysfunction, which may , in the opinion of the Investigator compromise a subject's ability to comply with study procedures, and/ or may confound data;
13. Applicable exclusionary criteria for standard lumbar MRI exam;
14. Has pending litigation, except where required by the insurer as condition of coverage;
15. BMI \> 40kg/m2

Primary outcomes:
measure: Oswestry Disability Index Assessment to assess improvement in lumbar pain
timeFrame: 24 months
Secondary outcomes:
measure: Visual Analog Scale (VAS) to assess the intensity of pain
timeFrame: 2 years
measure: Demonstrate correlation of NOSCISCORE results to Provocative Discography +/- results in subset of study subjects that receive pre-operative provocative discogram
timeFrame: 24 months
Other outcomes:
Locations:
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
Study officials:
References: