FLO for Discogenic Pain
| Status: | Terminated |
|---|---|
| Conditions: | Back Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 3/17/2019 |
| Start Date: | August 13, 2018 |
| End Date: | March 4, 2019 |
FLO Injection for Discogenic Pain
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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