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Study Site Ceased all Business Operations
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMUC Dosage 1 | Experimental | 25mg amniotic and umbilical cord matrix |
|
| AMUC Dosage 2 | Experimental | 50mg amniotic and umbilical cord matrix |
|
| AMUC Dosage 3 | Experimental | 100mg amniotic and umbilical cord matrix |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amniotic and umbilical cord matrix | Other | Cryopreserved human amniotic and umbilical cord product derived from donated human placental tissue following healthy, live, caesarian section, full-term births after determination of donor eligibility and placenta suitability. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient back pain determined by visual analog scale | 0 to 100mm, 100mm worst pain | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life determined by SF-36 | Short FormHealth Survey to evaluate quality of life across eight scales | 3 and 6 months |
| Change in patient back pain determined by visual analog scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser Spine Institute | Tampa | Florida | 33607 | United States |
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0 to 100mm, 100mm worst pain
| 6 months |
| Change in Oswestry Disability Index | 0 to 50, higher the percentile, the worse the perceived lower back pain | 3 and 6 months |