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

NCT04102761 | Completed

• 1 other identifier: N003R113
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 4

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).

Conditions

Internal Disc Disruption

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Patient Satisfaction

  Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year.

• Hospitalization

  Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year.

• Spine Surgery

  Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year.

• Medications

  Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year.

Study Arms (3)

Trigger Point Needling

PLACEBO COMPARATOR

The first group will receive a deep trigger point injection of saline into deep tissue.

Procedure: Intradiscal PRP & BMC Injections

Platelet Rich Plasma Injection

ACTIVE COMPARATOR

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

Bone Marrow Aspirate Injection

ACTIVE COMPARATOR

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

Interventions

Intradiscal PRP & BMC Injections PROCEDURE

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).

Bone Marrow Aspirate Injection; Platelet Rich Plasma Injection; Trigger Point Needling

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Annu Navani: lead
• Andrews Research & Education Foundation: collaborator

Study Sites (4)

Alex Hames

Campbell, California, 95008, United States

Location

The Orthohealing Center

Los Angeles, California, 90025, United States

Location

Texas Spine and Joint Hospital

Tyler, Texas, 75701, United States

Location

Nexus Pain Care

Provo, Utah, 84604, United States

Location

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Study Officials

• Annu Navani, MD

  Comprehensive Spine & Sports Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: September 25, 2019
• Study Start: March 27, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)