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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04102761
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Andrews Research & Education Foundation
Information provided by (Responsible Party):
Annu Navani, MD, Comprehensive Spine & Sports Center, Campbell, CA

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).

Condition or disease Intervention/treatment Phase
Internal Disc Disruption Procedure: Intradiscal PRP & BMC Injections Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : December 27, 2019
Estimated Study Completion Date : December 27, 2019

Arm Intervention/treatment
Placebo Comparator: Trigger Point Needling
The first group will receive a deep trigger point injection of saline into deep tissue.
Procedure: Intradiscal PRP & BMC Injections
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).

Active Comparator: Platelet Rich Plasma Injection
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
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).

Active Comparator: Bone Marrow Aspirate Injection
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
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).




Primary Outcome Measures :
  1. Worsening of Disc Pathology with Injection of Biologics [ Time Frame: 24 weeks post procedure ]
    Pre and post op discs will be examined and compared for worsening pathology.

  2. Improvement in Disc Pain with Injection of Biologics [ Time Frame: 24 weeks post procedure ]
    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)

  3. Improvement in Function in Patients with Injection of Biologics [ Time Frame: 24 weeks post procedure ]
    Pre and post op function will be measured and compared by Oswestry Disability Index (ODI)


Secondary Outcome Measures :
  1. Patient Satisfaction [ Time Frame: Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year. ]
    Patient satisfaction will be measured by the modified North American Spine Surgery (NASS) Outcome Questionnaire

  2. Hospitalization [ Time Frame: Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year. ]
    Hospitalization will be measured by patient's self report.

  3. Spine Surgery [ Time Frame: Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year. ]
    Spine Surgery will be measured by patient's self report.

  4. Medications [ Time Frame: Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year. ]
    Medications will be measured by patient's self report.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04102761


Contacts
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Contact: Michelle Galvis (408)404-4067 mgalvis@cssctr.com

Locations
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United States, California
Comprehensive Spine & Sports Center Recruiting
Campbell, California, United States, 95008
Contact: Michelle Galvis    408-404-4067    mgalvis@cssctr.com   
Contact: Lorraine Meza    (408)356-5292 ext 130    lmeza@cssctr.com   
Sub-Investigator: Gang Li, MD, PhD         
Principal Investigator: Annu Navani, MD         
The Orthohealing Center Recruiting
Los Angeles, California, United States, 90025
Contact: Isabel Perez    310-453-5404    isabel@orthohealing.com   
Contact: Eduardo Ruiz    (310) 453-5404    eduardo@orthohealing.com   
Principal Investigator: Mary Ambach, MD         
United States, Texas
Texas Spine and Joint Hospital Recruiting
Tyler, Texas, United States, 75701
Contact: Jeanetta Patterson, RN BA    903-531-0566    jeanettap@psctyler.com   
Principal Investigator: Aaron Calodney, MD         
United States, Utah
Nexus Pain Care Recruiting
Provo, Utah, United States, 84604
Contact: Shiona MacKay    801-356-6100    shiona@nexuspainspecialists.com   
Principal Investigator: Richard Rosenthal, MD         
Sponsors and Collaborators
Annu Navani, MD
Andrews Research & Education Foundation
Investigators
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Principal Investigator: Annu Navani, MD Comprehensive Spine & Sports Center

Publications:

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Responsible Party: Annu Navani, MD, Principal Investigator, Comprehensive Spine & Sports Center, Campbell, CA
ClinicalTrials.gov Identifier: NCT04102761    
Other Study ID Numbers: N003R113
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No