Randomized Evaluation of Lumbar Injection Effectiveness and Function (RELIEF)

October 2, 2026 updated by: SpinaFX Medical Inc.

Safety and Effectiveness of the Triojection® System in Patients With Symptomatic Lumbar Radiculopathy With or Without Back Pain Resultant From a Contained Herniated Lumbar Disc (L1-S1): A Pivotal, Randomized, Prospective, Multi-centered Study

The goal of this clinical trial is to learn whether the Triojection® System is safe and effective for treating symptomatic lumbar radiculopathy (leg pain caused by nerve irritation or compression) resulting from a contained herniated lumbar disc. The study will enroll adults 18 to 75 years of age with a single-level contained lumbar disc herniation who continue to have symptoms despite at least 6 weeks of non-surgical treatment and a previous lumbar spine injection.

The main questions it aims to answer are:

  • Does treatment with the Triojection® System improve leg pain and overall clinical outcomes compared with Selective Nerve Root Block (SNRB) alone?
  • Is treatment with the Triojection® System safe, as measured by the absence of device- or procedure-related serious adverse events and persistent neurological deficits?

Researchers will compare participants who receive Triojection® followed by SNRB with participants who receive SNRB alone to determine whether the investigational treatment provides improved clinical outcomes.

Participants will:

  • Be randomly assigned to receive either Triojection® plus SNRB or SNRB alone.
  • Complete questionnaires about leg pain, back pain, disability, quality of life, sleep, anxiety, depression, and overall improvement.
  • Undergo physical and neurological examinations during study follow-up visits.
  • Have MRI scans performed at selected study visits to evaluate changes in the treated disc.
  • Attend follow-up visits at 1, 3, 6, 12, 18, and 24 months after treatment.

Up to 300 participants will be enrolled at up to 30 investigational sites in the United States and Canada and followed for approximately 24 months after treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Symptomatic lumbar disc herniation is a common cause of lumbar radiculopathy and may result in leg pain, with or without back pain, that can significantly affect daily activities and quality of life. Many patients improve with non-surgical treatment; however, some continue to experience symptoms despite conservative care and spinal injections and may ultimately consider surgical intervention.

This study is a prospective, randomized, participant-blinded, multi-center clinical trial designed to evaluate the safety and effectiveness of the Triojection® System for the treatment of symptomatic lumbar radiculopathy associated with a single-level contained herniated lumbar disc. The Triojection® System is an investigational device that generates and delivers a controlled ozone-oxygen gas mixture into the affected intervertebral disc under image guidance. The intended mechanism is reduction of disc volume through dehydration of disc material, which may reduce pressure on adjacent nerve structures and relieve symptoms.

Approximately 300 participants will be randomized and treated at up to 30 investigational sites in the United States and Canada. Eligible participants will be adults 18 to 75 years of age with symptomatic lumbar radiculopathy resulting from a single-level contained lumbar disc herniation who have failed at least 6 weeks of non-surgical care and have previously undergone a lumbar spine injection with documented initial symptom improvement and subsequent recurrence of symptoms.

Participants will be randomized in a 1:1 ratio to one of two treatment groups:

  • Investigational treatment: Triojection® System followed by Selective Nerve Root Block (SNRB).
  • Control treatment: SNRB alone.

Participants will be followed for 24 months after treatment. Clinical evaluations will include patient-reported outcome measures, neurological and physical examinations, monitoring of adverse events, medication review, and assessment of additional treatments or surgical interventions. MRI evaluations will be performed at baseline and selected follow-up visits to assess radiographic changes in the treated disc.

The primary effectiveness evaluation will assess composite clinical success at 6 months after treatment, including improvement in leg pain and freedom from additional interventions or surgery at the treated level. The primary safety evaluation will assess freedom from device- or procedure-related serious adverse events and persistent new or worsening neurological deficits through 6 months. Secondary and exploratory assessments will evaluate disability, quality of life, pain outcomes, imaging findings, and long-term clinical outcomes through 24 months.

The results of this study are intended to provide evidence regarding the safety and effectiveness of the Triojection® System for treating symptomatic lumbar radiculopathy caused by a contained herniated lumbar disc.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • In order to be eligible to participate in this study, participants must meet all of the following criteria:

    1. Age between ≥18 (skeletally mature) - 75 (inclusive)
    2. A single contained posterior lumbar disc herniation, at a single level L1-S1, no greater than 30% of the canal size confirmed by radiographic imaging (via MRI/Axial MRI sequence)
    3. Has a preoperative leg VAS ≥ 50 /100 mm in worse leg AND worse leg is at least 20mm greater than the other leg
    4. The target level herniated disc must have a disc height of at least 33% (1/3) that of the adjacent disc levels, as determined by the investigator
    5. The patient must have pain in a dermatomal distribution consistent with their radiographic findings.
    6. Presents with leg pain for at least 6 weeks and that has not responded to conservative therapies (e.g., bed rest, physical therapy, medications, transcutaneous electrical nerve stimulation [TENS], etc.).
    7. Patient must have had a single previous epidural steroid injection or selective nerve root block at the target level with documentation of initial response and recurrence of symptoms (Prior injection must be at least 2 weeks or greater from screening visit)
    8. Psychosocially, mentally and physically able to fully comply with the clinical protocol, provide informed consent, and willing to adhere to follow-up schedule and requirements

Exclusion Criteria:

  • Participants who meet any of the following criteria will be excluded from participating in this study:

    1. Evidence of a symptomatic lumbar herniation at more than one level confirmed by patient history and radiographic imaging (via MRI)

    2. Functional neurological deficit evident during neurological exam such as drop foot, incontinence, intractable pain, loss of bladder or bowel control, or rapidly worsening symptoms

    3. Previous spine surgery in the lumbar region involving the index or adjacent level disc as evident on MRI, or instrumented hardware (e.g., total disc replacement, fusion) at any lumbar spine level

    4. Earlier spinal procedures in the lumbar region involving the index or adjacent level discs (basal nerve ablation, radiofrequency ablation, MILD procedure)

    5. Distal spinal cord compression on CT/MRI

    6. Evidence of cauda equina syndrome

    7. Structural deformities i.e.,

      1. ≥ Grade 2 spondylolisthesis (Up to Grade 1 allowed);
      2. Severe Spinal canal stenosis;
      3. Scoliosis > 10 degree Cobb Angle;
      4. Loss of lumbar lordosis (i.e., flatback-syndrome diagnosis);
      5. Hyperlordosis > 10 degrees;
      6. Spinal fracture (at any level);
      7. Disc extrusions or sequestered herniation as evident on CT/MRI.

    8. Evidence of a lumbar disc herniation with a maximal protrusion of disc material >4 mm beyond the posterior vertebral body margin, as assessed by screening MRI.

    9. Calcified disc fragment as evident on CT/MRI

    10. Inaccessible index disc (e.g. due to, overlap of the iliac wings, and/or steep angulation of the L5/S1 disc space.)

    11. Participant has a bleeding disorder, medical condition, or is taking medications that would result in elevated risk (e.g., blood clotting) to undergoing the surgical procedure; or any other clinical reasons deemed by the Investigator in which the patient would not be an appropriate candidate for the study.

    12. Any evidence of osteomyelitis/discitis at any level

    13. Uncontrolled/acute illness

    14. Women who are pregnant or planning to become pregnant during follow-up time period.

    15. Worker's compensation, injury litigation, disability remuneration.

    16. Active participation in another clinical investigation or course of care that may confound the outcome of this study

    17. Systemic infection or infection at the procedure site

    18. Currently a prisoner

    19. Leg pain of non-spinal or unknown etiology

    20. Participant has a spinal cord stimulator

    21. Diabetes with an HbA1c > 8.5

    22. Severe peripheral neuropathy

    23. Active foot ulcer

    24. Any known allergy to steroids or SNRB anesthetic

    25. Lumbar myelopathy

    26. Active malignancy or planned chemotherapy during follow-up time period

    27. Body Mass Index > 35

    28. Evidence of chronic low back pain for ≥ 12 months that is non-responsive to conservative therapy

    29. Current or recent history (within 90 days of screening) of chemical/alcohol abuse or dependency using standard medical definition of Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) code

    30. Current or recent history (within 90 days of screening) of Severe anxiety using standard medical definition of Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) code

    31. Current or recent history (within 90 days of screening) of Major Depressive Disorder using standard medical definition of Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) code

    32. Any contraindication for MRI (e.g. claustrophobia)

    33. Participant has had a previous lumbar discogram

    34. Participant has modic changes at the treatment level (Type 3)

    35. Participant has a Schmorl's node at the proposed treatment level

    36. Participant has opioid medication usage > 20 MME (morphine milligram equivalent)/day or change in opioid prescription within 60 days of procedure

    37. Participant is currently using a Fentanyl patch (at time of screening)

    38. Participant has a known G6PD deficiency disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Investigational: Triojection® System + Selective Nerve Root Block (SNRB)

Participants randomized to the investigational group will receive treatment with the Triojection® System, consisting of an intradiscal ozone-oxygen injection (35 ± 3 µg/mL ozone in oxygen), followed by a Selective Nerve Root Block (SNRB) using dexamethasone and 0.25% bupivacaine (Marcaine).
Device: Triojection® System

The Triojection® System is an investigational device that generates and delivers 12 mL of an ozone-oxygen gas mixture at a concentration of 35 ± 3 µg/mL ozone in oxygen for image-guided intradiscal injection into a contained herniated lumbar disc.

Procedure: Selective Nerve Root Block (SNRB)

Image-guided injection of dexamethasone and 0.25% bupivacaine (Marcaine) around the affected lumbar nerve root as standard of care treatment for lumbar radiculopathy.

These arm and intervention entries follow the standard ClinicalTrials.gov format for a randomized device study with an active comparator.
Active Comparator: Active Comparator: Selective Nerve Root Block (SNRB) Alone

Participants randomized to the control group will receive a Selective Nerve Root Block (SNRB) using dexamethasone and 0.25% bupivacaine (Marcaine) without treatment with the Triojection® System.
Procedure: Selective Nerve Root Block (SNRB)

Image-guided injection of dexamethasone and 0.25% bupivacaine (Marcaine) around the affected lumbar nerve root as standard of care treatment for lumbar radiculopathy.

These arm and intervention entries follow the standard ClinicalTrials.gov format for a randomized device study with an active comparator.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite Clinical Success at 6 Months
Time Frame: 6 Months

Composite clinical success at 6 months requiring achievement of all of the following components:

  • Improvement of at least 20 mm in worse-leg Visual Analog Scale (VAS) pain score compared with baseline
  • Freedom from reintervention or conversion to surgery at the index level
  • Freedom from device- or procedure-related serious adverse events (SAEs) or persistent new or worsening neurological deficit
6 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ODI Responder Rate at 6 Months
Time Frame: 6 Months

Proportion of participants achieving an improvement of at least 15 points in Oswestry Disability Index (ODI) score compared with baseline.
6 Months
Leg Pain Responder Rate at 6 Months
Time Frame: 6 Months

Proportion of participants achieving an improvement of at least 20 mm in worse-leg Visual Analog Scale (VAS) pain score compared with baseline.
6 Months
Incidence of Related Adverse Events and Serious Adverse Events
Time Frame: Through 24 Months

Incidence of treatment-related adverse events (AEs) and serious adverse events (SAEs).
Through 24 Months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Response at 12 Months
Time Frame: 12 Months

Proportion of participants achieving at least a 20 mm improvement in worse-leg VAS pain score compared with baseline.
12 Months
ODI Responder Rate at 12 Months
Time Frame: 12 Months

Proportion of participants achieving an improvement of at least 15 points in ODI score compared with baseline.
12 Months
Patient Global Impression of Change (PGIC)
Time Frame: 1, 3, 6, and 12 Months

Participant-reported overall change following treatment.
1, 3, 6, and 12 Months
Change in ODI Score
Time Frame: 6 and 12 Months

Change from baseline in Oswestry Disability Index score.
6 and 12 Months
Change in Leg and Back Pain VAS Scores
Time Frame: 6 and 12 Months

Change from baseline in leg pain and back pain Visual Analog Scale scores.
6 and 12 Months
Change in PROMIS-29 Score
Time Frame: 6 and 12 Months

Change from baseline in Health-Related Quality of Life (PROMIS-29) scores.
6 and 12 Months
Change in Insomnia Severity Index (ISI) Score
Time Frame: 6 and 12 Months

Change from baseline in ISI score.
6 and 12 Months
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
Time Frame: 6 and 12 Months

Change from baseline in GAD-7 score.
6 and 12 Months
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Time Frame: 6 and 12 Months

Change from baseline in PHQ-9 score.
6 and 12 Months
Change in Neurological Examination Findings
Time Frame: 6 and 12 months

Change from baseline in motor, sensory, reflex, and straight-leg-raise neurological assessments.
6 and 12 months
MRI Assessment of Disc Morphology
Time Frame: Base, 6 Months, and 12 Months

MRI evaluation of disc herniation size, disc height, and disc degeneration using the modified Pfirrmann scale.
Base, 6 Months, and 12 Months
Time to Additional Intervention at the Treated Level
Time Frame: Through 12 Months

Time from index treatment to additional intervention at the treated level.
Through 12 Months
Healthcare Resource Utilization and Work Status
Time Frame: Through 12 Months

Cost analysis including subsequent treatments and work status.
Through 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SpinaFX Medical Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IQVIA Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 14, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 6, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SFX-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

At the time of study registration, the sponsor has not yet determined whether de-identified individual participant data (IPD) will be made available to other researchers. Any future decisions regarding data sharing will consider participant privacy, informed consent provisions, applicable regulatory requirements, and sponsor policies. If a data-sharing plan is established, the ClinicalTrials.gov record will be updated accordingly.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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