NOCISCAN-Lumbar Spine (LS) Clinical Evaluation Study

Nocimed

Status: Not yet enrolling

Conditions: Lumbar Disc Disease

Treatments: Other: NOCISCAN-LS Disc MR Spectroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT04015791

NM005

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

240 participants in 2 patient groups

Match Group

Description:

Surgery conducted at the disc level corresponding with the highest level of NOCISCORE value in the subject and that is classified as either NOCI + or NOCI mild

Treatment:

Other: NOCISCAN-LS Disc MR Spectroscopy

Miss Group

Description:

Surgery conducted at a disc that: (a) corresponds with a low relative NOCISCORE value in the subject and that is classifies as NOCI - or (b) excludes the disc level with the highest NOCISCORE value in the subject and that is classifies as NOCI+ or NOCI mild

Treatment:

Other: NOCISCAN-LS Disc MR Spectroscopy