Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes

Launched by ACLARION · Oct 25, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new tool called NOCISCAN, which helps doctors identify whether specific discs in the lower back are causing pain. By using a special imaging technique called Magnetic Resonance (MR) spectroscopy, NOCISCAN aims to make it easier for physicians to determine if surgery is needed for patients suffering from discogenic low back pain. The trial will compare the results of patients who have their disc evaluations done using NOCISCAN with those who do not, to see how it impacts their surgical outcomes.

To be eligible for this study, participants must be between 18 and 70 years old and plan to have surgery for their back pain. They should have already tried at least six months of non-surgical treatments, such as physical therapy or medications, without success. Participants will need to complete some questionnaires and follow up with the study team after their surgery. It's important to note that certain conditions, like prior back surgeries or specific spinal issues, may exclude someone from participating. This trial is currently not recruiting participants yet, but it aims to provide valuable information about the effectiveness of NOCISCAN in helping treat low back pain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject is a skeletally mature male or female (non-pregnant) aged 18 to 70 years (inclusive);
• • 2. Subject is plans to undergo surgical treatment of their discogenic back pain independent of this research protocol;
• • 3. Subject is to be treated with on-label use of FDA-cleared or FDA-approved devices independent of this research protocol;
• • 4. Subject has a primary diagnosis of discogenic back pain in up to two lumbar levels caused by degenerative disc disease identified via MRI;
• • 5. Subject has a preoperative Oswestry Disability Questionnaire score ≥40 out of 100 points (40/100);
• • 6. Subject has a VAS back pain score of ≥40mm and that is greater than the worst VAS leg pain score;
• • 7. 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);
• • 8. Subject has signed the IRB approved Informed Consent Form; and
• • 9. 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.
• Exclusion Criteria:
• • 1. Subject has a primary diagnosis of spinal condition other than degenerative disc disease at the involved level (i.e., facet joint pain/SI pain);
• • 2. 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);
• • 3. Surgery is planned for more than 2 lumbar levels.
• • 4. Subject has clinically significant spinal canal stenosis as assessed by the Investigator;
• • 5. Subject has a motor strength deficit(s) in lower extremities
• 6. 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 with more than 2 mm of translation, or with 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
• • 7. Subject has radiologic evidence of lumbar disc herniation comprising extrusion
• • 8. Subject is contraindicated for a standard lumbar MRI exam
• • 9. 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
• • 10. Subject is currently receiving worker's compensation or is involved in in any litigation for personal injury, medical negligence, trauma, or worker's compensation.
• • 11. 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
• • 12. Subject has a BMI \> 40