Trial · NCT07910422
Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
NCT07910422, Enrolling by invitation, Beam Research, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation. Trials, record NCT07910422. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07910422
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
- NCT number
- NCT07910422
- Status
- Enrolling by invitation
- Enrollment
- 80 participants, estimated
- Lead sponsor
- Beam Research, Inc.
- Conditions
- Lumbar Disc Herniation
- Interventions
- Intradiscal ozone-oxygene injection
- First posted
- 2026-11-02
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical success | Index procedure and up 180 days post-procedure [0, 180 d]. | Four-prong, Composite Clinical Success (CCS) |
| Primary | Incidence of Adverse Events (AEs). | Through study completion, average of 3 months | Adverse events, including vital signs, clinical laboratory and/or other clinical measurements performed during the standard course of medical of care, will be assessed as per type, incidence, duration, severity, seriousness, and causal relationship to the device and study procedure. |
| Secondary | Oswestry Disability Index (ODI) | Change in ODI will be evaluated at 6 weeks, 3 months, 6 months, 12 months, 24 months, and > 24 months. | Absolute and Mean Change from baseline in Oswestry Disability Index (ODI) and proportion of responders. |
| Secondary | Pain (Visual Analog Scale or Numeric Rating Scale) | Change in pain will be evaluated at 6 weeks, 3 months, 6 months, 12 months, 24 months, and > 24 months. | Absolute and Mean change from baseline in Visual Analog (VAS) or Numeric Rating Scale (NRS) leg pain and proportion of responders. VAS (Visual Analog Scale): 10 cm (100 mm) horizontal line. Left = No pain. Right = Worst imaginable pain. Measured distance (cm or mm) from left end up to subject-reported point on the line. NPRS (Numeric Pain Rating Scale): 0 to 10. 0 = No pain. 10 = Worst imaginable pain. |
| Secondary | Subsequent surgical interventions (SSIs) | SSIs will be evaluated at 3 months, 6 months, 12 months, 24 months, and > 24 months. | Freedom from subsequent surgical interventions (SSIs) (any discectomy) at the index level(s) |
| Secondary | Clinically significant non-surgical treatments | Clinically significant non-surgical treatments will be evaluated at 3 months, 6 months, 12 months, 24 months, and > 24 mon | Freedom from clinically significant non-surgical treatments defined as intradiscal injections at an index level, or other injection use in the lumbar spine (i.e., trigger point or epidural steroid injection (ESI), and/or increase of opioid analgesics (Morphine milligram equivalent \[MME\]) |
| Other | Pain Inventory | Through Study Completion, average of 3 months | Patient-Reported Pain Inventory using Numerical Pain Rating Scale (NPRS) and study-specific Questionnaire (7 questions). NPRS (Numeric Pain Rating Scale): 0 to 10. 0 = No pain. 10 = Worst imaginable pain. |
| Other | Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 8b | Through study completion, average of 3 months | 8-item patient-reported outcome tool evaluating physical function. Each item is scored on a 5-point Likert scale ranging from 1 ('Unable to do') to 5 ('Without any difficulty'). Raw scores are converted to a standardized T-score |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07910422
GET https://conductscience.org/api/trials/v1/NCT07910422/registered