Nociscan for Discogenic Low Back Pain

(CLARITY Trial)

Recruiting at 3 trial locations

Overseen By Teleah Davis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aclarion

Disqualifiers: Spinal stenosis, Motor deficit, Spondylolisthesis, Scoliosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Varies per patient

300 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since participants must have failed at least 6 months of non-operative treatment, it might be possible to continue some medications. Please consult with the trial coordinators for specific guidance.

What data supports the effectiveness of the treatment Nociscan for discogenic low back pain?

The research mentions that thermal annular procedures (TAPs), which involve using heat to treat discogenic pain, are among the best-studied treatments for this condition, suggesting that similar approaches may be effective. ^{1 2 3 4 5}

How is the Nociscan treatment different from other treatments for discogenic low back pain?

Nociscan is unique because it is a diagnostic tool rather than a direct treatment, potentially offering a more precise identification of painful discs compared to other therapies that focus on treatment without specific diagnosis. This approach could lead to more targeted and effective management of discogenic low back pain. ^{1 4 5 6 7}

What is the purpose of this trial?

This study is looking into how safe and useful NOCISCAN is. NOCISCAN is a software as a Service (SaaS) tool that uses Magnetic Resonance (MR) spectroscopy. Nociscan (instead of 'It') leverages MRS to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. The randomized controlled trial will compare the blinded and unblinded cohorts and their corresponding surgical outcomes with the Nocigram reports, generated prior to treatment, for each patient."

Eligibility Criteria

This trial is for adults aged 18-70 with discogenic low back pain, who have not improved after at least 6 months of non-surgical treatments. They must be planning to undergo spine surgery using FDA-approved devices and have specific scores on pain and disability assessments. Pregnant individuals or those unable to follow the study protocol are excluded.

Inclusion Criteria

I plan to have surgery for my back pain not related to this study.

My back pain severely limits my daily activities.

Subject has signed the IRB approved Informed Consent Form

Exclusion Criteria

Subject is contraindicated for a standard lumbar MRI exam

Subject is currently receiving worker's compensation or is involved in any litigation for personal injury, medical negligence, trauma, or worker's compensation

I have a diagnosed spine condition confirmed by X-rays.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

NOCISCAN is completed pre-operatively to distinguish between painful and nonpainful discs in the lumbar spine

1-2 weeks

Treatment

Participants undergo surgical treatment for discogenic low back pain, with blinded and unblinded cohorts compared

Varies per patient

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple intervals

24 months

Follow-up visits at 3, 6, 12, and 24 months

Treatment Details

Interventions

• Nociscan

Trial Overview The trial examines NOCISCAN, a software tool that uses MR spectroscopy to differentiate between painful and nonpainful spinal discs. It aims to see if knowing which discs are causing pain before surgery leads to better outcomes than not having this information.

Participant Groups

Group I: Unblinded-to-NOCISCAN Experimental Treatment 1 Intervention

NOCISCAN completed pre-operatively. Investigator will have access to the NOCISCAN result after completing initial treatment plan but before treatment.

Group II: Blinded-to-NOCISCAN Experimental Treatment 1 Intervention

NOCISCAN completed pre-operatively. Investigator will not have access to NOCISCAN result.

Who Is Running the Clinical Trial?

Aclarion

Lead Sponsor

Trials

1

Recruited

300+

MCRA

Industry Sponsor

Trials

40

Recruited

11,100+

Findings from Research

Percutaneous biacuplasty has strong evidence (Level I) supporting its efficacy in treating chronic, refractory discogenic pain, making it a recommended first-line treatment option based on the review of 49 studies, including 4 randomized controlled trials (RCTs).

Intradiscal electrothermal therapy (IDET) shows moderate evidence (Level III) for efficacy in treating the same condition, while the evidence for discTRODE is limited (Level V), indicating that more research is needed to validate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Thermal Annular Procedures in Treating Discogenic Low Back Pain. Helm Ii, S., Simopoulos, TT., Stojanovic, M., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Intradiscal Therapies for Lumbar Degenerative Disk Disease. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Intradiscal glucocorticoids injection in chronic low back pain with active discopathy: A randomized controlled study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trials in industrial low back pain relating to return to work. Part 2. Discogenic low back pain. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

[Discogenic low back pain and degenerative lumbar spinal stenosis - how appropriate is surgical treatment?]. [2011]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Thermal Annular Procedures in Treating Discogenic Low Back Pain. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy of the Gelstix nucleus augmentation device for the treatment of chronic discogenic low back pain: protocol for a randomised, sham-controlled, double-blind, multicentre trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Radiofrequency lesioning of the L2 ramus communicans in managing discogenic low back pain. [2006]