A Prospective Study of Clinical Outcomes Following a Single Intradiscal Injection of Bone Marrow … (NCT03912454) | Clinical Trial Compass
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A Prospective Study of Clinical Outcomes Following a Single Intradiscal Injection of Bone Marrow Aspirate Concentrate (BMAC) for Single Level Discogenic Low Back Pain
United States20 participantsStarted 2019-04-08
Plain-language summary
This single-institution prospective case series (single arm) study will assess the clinical outcomes of patients diagnosed with 1 or 2 level level discogenic low back pain following an intradiscal injection of bone marrow aspirate concentrate (BMAC).
Who can participate
Age range18 Years – 60 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:
* Ages 18 to 60 years
* Symptomatic discogenic low back pain, clinically demonstrated by a loss of lumbar range of motion and pain to deep palpation over the symptomatic disc.
* MRI confirmed single level lumbar disc height loss \<50% (Modified Pfirrman grade \<=7).
* MRI confirmed isolated lumbar disc degeneration OR
o If zygapophysial joint degeneration is present on MRI, subject must have failed intra-articular injection or medial branch block (\<50% pain relief) to be eligible for enrollment. PI will have final discretion as to whether the patient's symptoms originate from a single disc.
* Patient must have completed at least 3 months conservative treatment. Conservative treatment may include NSAIDs or Acetaminophen when medically appropriate and physiotherapy, chiropractic care, or a guided home exercise program.
* BMI \< 40
* Back pain greater than leg pain with back pain rating on a 100 mm visual analog scale (VAS) \>= 40 mm
* Pain Catastrophizing Scale \<= 30
Exclusion Criteria:
* Prior fusion at the level to be treated
* \>2 levels requiring intervention
* Non discogenic source of back pain
* Intradural disc herniation
* Full thickness annular tear at the index level.
* Lumbar spine surgery within the past 6 months.
* Pregnant or breastfeeding.
* Known allergy or sensitivity to heparin or citrate (used for processing BMAC)
* Coagulopathy preventing spinal injection
* Active infection
* Malignancy within past 5 years other than basal cell or …
What they're measuring
1
Change in Visual Analog Scale (VAS) Pain Score
Timeframe: 1 day (Pre-injection) to 12 months post-injection
2
Change in Oswestry Disability Index
Timeframe: 1 day (Pre-injection) to 12 months post-injection