Aclarion is committed to developing ongoing clinical and economic evidence as we work to advance the care of patients suffering from chronic low back pain.
CLARITY Trial
The CLARITY Trial, short for Chronic Low Back Pain Randomized Independent Trial studY, is a prospective, randomized, multi-center clinical study designed to evaluate whether Nociscan can help improve surgical outcomes for patients with discogenic low back pain.
Nociscan leverages magnetic resonance spectroscopy (MRS), biomarkers and augmented intelligence algorithms to provide spine surgeons with objective information beyond conventional imaging. For patients, this may support a more personalized surgical plan by helping identify the discs most likely associated with their pain. For physicians, Nociscan provides additional decision-support data intended to improve confidence in surgical planning and help align treatment with the patient’s specific pain-generating pathology.
The CLARITY Trial is a post-market study expected to enroll 300 patients across multiple high-volume spine centers. Patients will be randomized 1:1 between surgeons who are blinded to Nociscan results and surgeons who use Nociscan results to guide surgical treatment. The principal investigator is Dr. Nicholas Theodore, Chairman of Neurosurgery at the University of Arizona College of Medicine – Phoenix.
Publications
Wilson L, Beall D, et al. The Comparison of Cost-Effectiveness Between Magnetic Resonance Spectroscopy and Provocative Discography in the Identification of Chronic Low Back Pain Surgery Candidates. Clinicoecon Outcomes Res. 2025 November;17:19-31.
Eastlack R, Jabour B. MR Spectroscopy and Low Back Pain: a Novel Cloud-based Solution. MAGNETOM Flash. (89) 4/2024 November.
Gornet M, Peacock J., et al. Establishing a Gold Standard for Noninvasive Identification of Painful Lumbar Discs: Prospective Comparison of Magnetic Resonance Spectroscopy vs Low-Pressure Provocation Discography
Gornet M, Eastlack R., et al. Magnetic resonance spectroscopy (MRS) identification of chemically painful lumbar discs leads to improved 6- 12- 24- month outcomes for discogenic low back pain surgeries. European Spine Journal. 2023 April;32:1973-1984.
Manfré L, Van Goethem J. The Disc and Degenerative Disc Disease: Remove or Regenerate? 2020 pp.97-121.
Gornet M, Peacock J, et al. Magnetic resonance spectroscopy (MRS) can identify painful lumbar discs and may facilitate improved clinical outcomes of lumbar surgeries for discogenic pain. European Spine Journal. 2019 January; 28:674-687.
Mulholland R. The Michel Benoist and Robert Mulholland yearly European spine journal review: a survey of the “surgical and research” articles in European spine journal, 2019 European Spine Journal. 2020 January; 29, 14-23.
Keshari K, Lotz J, et al. Lactic acid and proteoglycans as metabolic markers for discogenic back pain. Spine 2008 February;33(3):312-7
Keshari K, Lotz J, et al. Correlation of HR-MAS spectroscopy derived metabolite concentrations with collagen and proteoglycan levels and Thompson grade in the degenerative disc. Spine. 2005 December; 30(23):2683-8
Keshari K, Zektzer A, et al. Characterization of intervertebral disc degeneration by high-resolution magic angle spinning (HR-MAS ) spectroscopy. Magn Reson Med. 2005 March; 53(3):519-27
Videos
ECR 2018 – Presentation by Dr. Stephen Becker, Orthopedic and Spine Surgeon, Vienna, Austria, “Lumbar Disc MRS: Can it help my daily practice?”
ECR 2018 – Presentation by Lawrence N. Tanenbaum, MD, FACR - Director of MRI, CT, and Advanced Imaging, VP and Medical Director, Eastern Region RadNet, “Physiologic Imaging of Spine Pain”
Podcasts
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Aclarion
8181 Arista Place,
Suite 100
Broomfield, CO 80021
