Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain (NCT03340818) | Clinical Trial Compass
CompletedNot Applicable
Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain
United States66 participantsStarted 2018-08-01
Plain-language summary
A double-blind, placebo-controlled study to determine the efficacy of intradiscal injection of bone marrow concentrate on discogenic low back pain.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Chronic low back pain for more than 6 months w/ low back component greater than leg pain.
* Average pain of at lest 40/100 on VAS pre-procedure.
* Inadequate response to at least 6 months of conservative care including medication, physical therapy and/or spinal injection
* Advanced imaging of MRI or CT demonstrating abnormal disc pathology
* Presumed lumbar disc pain based on either positive discogram or patient must have MRi findings of either high intensity zone and/or Type 1 or 2 Modic endplate changes, or exclusion of other sources of pain.
* Having provided informed consent
Exclusion Criteria:
* Active moderate to severe lumbar radiculopathy
* Negative discogram
* Very severe decrease in disc height at planned injection level (disc height of less than 1/3 expected)
* Active infection
* Moderate to severe anemia, thrombocytopenia or leukopenia
* Spinal fracture within the past 6 months
* Severe psychological illness
* Inability to consent to the procedure due to cognitive issues
* Prior surgery at a level considered to be the source of pain
* Lumbar surgery within the past 6 months
* Women who are pregnant or breast feeding
* Prior intradiscal therapeutic injection or procedure
* Severe uncontrolled renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological disease or any medical condition which would make the subject unsuitable for this study.
* Inflammatory arthritis
* Any cancer within the past 5 yea…