NOCISCAN-Lumbar Spine (LS) Clinical Evaluation Study

Launched by NOCIMED, LLC · Jul 8, 2019

Keywords

ClinConnect Summary

The NOCISCAN-Lumbar Spine Clinical Evaluation Study is a research trial designed to improve how doctors identify painful lumbar discs in patients with degenerative disc disease, which is a common cause of back pain. The study aims to see if a special software called NOCISCAN-LS can help predict which discs are causing pain and whether using this information leads to better surgical outcomes after spine surgery. Participants will be followed for up to two years after their surgery to evaluate their recovery and pain levels.

To be eligible for this study, participants must be between 18 and 70 years old and have a history of back pain related to degenerative disc disease that has not improved with at least six months of non-surgical treatments like physical therapy or medications. They need to have specific imaging results showing changes in their spinal discs. This trial is not yet recruiting, but it will be open to both men and women. If you decide to participate, you'll undergo evaluations to assess your condition and receive the necessary care throughout the study.

Gender

ALL

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