The condition being studied is chronic low back or leg pain in patients with internal disc disruption (IDD). The intervention to be studied is the intradiscal delivery of autologous Platelet Rich Plasma (PRP) or bone marrow concentrate (BMC) into the nucleus pulposus of the disrupted disc(s).
This multi-center randomized controlled pilot trial will be the first to evaluate the response of PRP and BMC for discogenic pain by direct comparison. The investigators propose to incorporate a crossover design that compares placebo to two treatment modalities (i.e. Neutrophil-Poor PRP \[NP-PRP\] and BMC). If the investigators can demonstrate statistically significant and clinically meaningful improvements in study's primary and secondary outcome measures, this study will have identified a natural, effective and sustainable treatment for discogenic back pain that currently accounts for the highest level of disability in US. This will help guide physicians in the choice of care between surgical and conservative treatment options when treating patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
The intervention to be studied is the intradiscal delivery of autologous Platelet Rich Plasma (PRP) or bone marrow concentrate (BMC) into the nucleus pulposus of the disrupted disc(s).
Alex Hames
Campbell, California, United States
The Orthohealing Center
Los Angeles, California, United States
Texas Spine and Joint Hospital
Tyler, Texas, United States
Nexus Pain Care
Provo, Utah, United States
Worsening of Disc Pathology with Injection of Biologics
Pre and post op discs will be examined and compared for worsening pathology.
Time frame: 24 weeks post procedure
Improvement in Disc Pain with Injection of Biologics
Pre and post op Pain will be measured and compared by Numeric Rating Scale (NRS) Numeric Pain Rating Scale (NRS): Measured from 0-10, 0 minimum score (better outcome) and 10 maximum score (worse outcome) Oswestry Low back disability (ODS): Measured from 0-50, 0 minimum score and 10 maximum score. The numbers are then calculated into percentages between 0% (minimum disability- better outcome)-100% (maximum disability- worse outcome) NASS Patient satisfaction Index (NASS): Measured from 0-4, 0 (better outcome) and 4 (worse outcome)
Time frame: 24 weeks post procedure
Improvement in Function in Patients with Injection of Biologics
Pre and post op function will be measured and compared by Oswestry Disability Index (ODI)
Time frame: 24 weeks post procedure
Patient Satisfaction
Patient satisfaction will be measured by the modified North American Spine Surgery (NASS) Outcome Questionnaire
Time frame: Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year.
Hospitalization
Hospitalization will be measured by patient's self report.
Time frame: Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year.
Spine Surgery
Spine Surgery will be measured by patient's self report.
Time frame: Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year.
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Medications
Medications will be measured by patient's self report.
Time frame: Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year.