FLO for Discogenic Pain
Stopped early · Not applicable
Conditions studied: Discogenic Back Pain
In brief
Discogenic pain is pain originating from a damaged vertebral disc and be caused by inflammation, dehydration of the nucleus pulposus, decreased disc height, annular tears and impaired mechanical function of the disc.Non-operative treatment may include traction, steroid therapy, methylene blue injection and ablative therapy. However, there are few high quality studies evaluating these treatments for reducing discogenic low back pain and most clinical trials failed to detect significant differences between treatments and placebo therapies. Hence, there remains an unmet clinical need.
Key facts
- Study ID
- NCT03644251
- Run by
- BioTissue Holdings, Inc
- People needed
- 3
- Starts
- 2018-08-13
- Expected to finish
- 2019-03-04
- Last updated by the study team
- 2019-03-15
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- subject (male or female) is at least 18 to 70 years of age
- diagnosed with single level discogenic back pain confirmed by MRI and positive discography per Spine Interventional Society Guidelines
- Diagnosis of disc degeneration with Pfirrmann score of 1-3
- Subject has failed at least six months of conservative care
- Subject is symptomatic with axial lower back pain greater than lower limb pain at the intensity of >6/10 concordant or partially concordant
- The subject is able to comply with all post-operative standard of care and follow instructions.
You may not qualify if…
- Subjects has significant disc protrusion, severe lumbar spinal stenosis, spine tumor, severe disc degeneration, or Sacroiliac (SI) joint syndrome
- Subject had previous surgery at the disc level
- Patient has previously received injection of FLO within 3 months of screening
- The subject is unable to comply with follow-up or not appropriate for inclusion based on investigator decision
Where it is running
- Laser Spine Institute — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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