Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT03340818
Eligibility Criteria:
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 years, except basal cell or squamous cell skin cancer
* Intradural disc herniation
* Coagulopathy preventing spinal injection
* Inability to stop anticoagulants other than aspirin due to other medical issues
* Exceeds 30 mg morphine equivalent per day of opioid use.
* A history of alcohol or drug abuse within the past 5 years.
* Use of any investigational drug within the past 30 days.
* Steroid injection in the spine within the past 30 days.
* Discography within the last 21 days
* A known allergy or sensitivity to heparin or citrate (used for processing BMC)
* Pending litigation involving the subject's back pain.
* Active worker's compensation claim
* Central stenosis at a level to be injected with an AP diameter less than or equal to 5 mm
* Severe anaphylactic/anaphylactoid reaction to any of the medications used. (If a patient does have a mild or moderate allergy to any of the medications used in the procedure or prior anaphylactic/anaphylactoid reaction to any food or drug, they will be given prednisone 50 mg PO 13, 7, and 1 hour prior to the procedure and diphenhydramine 50mg PO 1 hour prior to the procedure.)
* In order to mitigate any economic risk, a patient without adequate medical insurance coverage for any subsequent tests or procedures deemed clinically necessary will be excluded. BMC is an autologous blood product with multiple clinical uses. Intradiscal administration should not preclude insurance coverage for any subsequent medical issues that might develop pertaining to the intradiscal injection itself or the BMC
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03340818
Study Brief:
Protocol Section:
NCT03340818