Clinical trial NCT04102761: The Use of PRP and BMC in Patients With Internal Disc Disruption Multicenter Prospective Randomized Controlled Trial in Patients With Internal Disc Disruption
Official title: Platelet Rich Plasma and Bone Marrow Aspirate for Lumbar Intradiscal Injections: A Multicenter Prospective Randomized Controlled Trial in Patients With Internal Disc Disruption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Internal Disc Disruption
Lead sponsor: Comprehensive Spine & Sports Center, Campbell, CA
Sponsor class: OTHER
Collaborators: name: Andrews Research & Education Foundation
First posted: 2019-09-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Worsening of Disc Pathology with Injection of Biologics
timeFrame: 24 weeks post procedure
measure: Improvement in Disc Pain with Injection of Biologics
timeFrame: 24 weeks post procedure
measure: Improvement in Function in Patients with Injection of Biologics
timeFrame: 24 weeks post procedure
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year.
measure: Hospitalization
timeFrame: Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year.
measure: Spine Surgery
timeFrame: Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year.
measure: Medications
timeFrame: Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year.
Other outcomes:
Locations:
city: Campbell
country: United States
facility: Alex Hames
state: California
city: Los Angeles
country: United States
facility: The Orthohealing Center
state: California
city: Tyler
country: United States
facility: Texas Spine and Joint Hospital
state: Texas
city: Provo
country: United States
facility: Nexus Pain Care
state: Utah
Study officials:
affiliation: Comprehensive Spine & Sports Center
name: Annu Navani, MD
role: PRINCIPAL_INVESTIGATOR
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