The Use of PRP and BMC in Patients With Internal Disc Disruption Multicenter Prospective Randomized Controlled Trial in Patients With Internal Disc Disruption

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Platelet Rich Plasma and Bone Marrow Aspirate for Lumbar Intradiscal Injections: A Multicenter Prospective Randomized Controlled Trial in Patients With Internal Disc Disruption

Conditions
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Internal Disc Disruption

Intervention / Treatment
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* Procedure: Intradiscal PRP & BMC Injections


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A high index of suspicion for discogenic pain, i.e. painful degenerative discs with or without contained protrusions Age greater than 18 and less than 70 years Maintained intervertebral disc heights of at least 50% Pain not generated from facet joints, sacro-iliac joints or any pathology other than discogenic origin. Pain is not responsive to conservative treatment measures (oral medications, epidural steroid injections, physical therapy) Pain persists for an extended period of time (i.e., at least 3 months) High intensity zone (HIZ) in annular fissure detected on T2 or STIR MRI, degenerated discs or contained disc protrusions. No evidence of contraindications to undergo procedure such as pregnancy, active infection, bleeding disorder, or metastatic cancer English speaking Exclusion Criteria: Disc extrusions, disc sequestrations, severe spinal stenosis, or severe disc degeneration with grade 5 Pfirmann index or with Modic 3 level change. Patient refusal Presence of a known bleeding disorder Pregnancy Systemic or local infection Presence of an unstable medical or psychiatric condition Prior intradiscal procedure (ie. IDET, Nucleoplasty) Inaccessibility to discs such as fusion Non-English speaking Prior fusion surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Subjects will be assigned to one of three arms of the study. The first group will receive a trigger point injection of saline into the deep tissue. The second group will receive an injection of approximately 1-2 mL of Platelet RP into the painful disc/discs. The third group will receive an injection of approximately 1-2 mL of Bone Marrow Concentrate into the painful disc/discs. No more than three discs will be injected.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Trigger Point Needling<br>The first group will receive a deep trigger point injection of saline into deep tissue. | Procedure: Intradiscal PRP & BMC Injections<br>* 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).<br>|
| Active Comparator: Platelet Rich Plasma Injection<br>The Platelet Rich Plasma group will receive an injection of approximately 1-2 mL of Platelet Rich Plasma into the painful disc/discs. | Procedure: Intradiscal PRP & BMC Injections<br>* 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).<br>|
| Active Comparator: Bone Marrow Aspirate Injection<br>The third group will receive an injection of approximately 1-2 mL of Bone Marrow Concentrate into the painful disc/discs. | Procedure: Intradiscal PRP & BMC Injections<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worsening of Disc Pathology with Injection of Biologics | Pre and post op discs will be examined and compared for worsening pathology. | 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) | 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) | 24 weeks post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Patient satisfaction will be measured by the modified North American Spine Surgery (NASS) Outcome Questionnaire | 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. | 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. | Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year. | 
| Medications | Medications will be measured by patient's self report. | Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year. |