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Study Of Disc Anaesthesia For The Preoperative Diagnosis Of Chronic Lower Back Pain (SODA Trial)

Phase 4
Waitlist Available
Led By Ray M Baker, MD
Research Sponsored by Medtronic Spine LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 hours per subject
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

The primary objective of this study is to document and compare diagnostic test results and procedure safety in subjects undergoing both Functional Anaesthetic DiscographyTM (F.A.D.) and provocative discography (PD) and determine the appropriateness of the F.A.D. procedure data collection script for use in a larger clinical trial.

Eligible Conditions
  • Lower Back Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 hours per subject
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 hours per subject for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in Number of Magnetic Resonance Imaging (MRI)-Positive Discs Diagnosed Positive by Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.)

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PD and F.A.D. diagnostic testingExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
functional anesthetic discography
2007
Completed Phase 4
~70
provocative discography
2007
Completed Phase 4
~70

Find a Location

Who is running the clinical trial?

Medtronic Spine LLCLead Sponsor
12 Previous Clinical Trials
1,658 Total Patients Enrolled
Ray M Baker, MDPrincipal InvestigatorUniversity of Washington
Rick D Guyer, MDPrincipal InvestigatorTexas Back Institute, Plano, TX
~3 spots leftby Jan 2026
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