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

Annu Navani

Status: Completed

Conditions: Internal Disc Disruption

Treatments: Procedure: Intradiscal PRP & BMC Injections

Study type: Interventional

Funder types: Other

Identifiers

NCT04102761

N003R113

Details and patient eligibility

About

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).

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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45 participants in 3 patient groups, including a placebo group

Trigger Point Needling

Placebo Comparator group

Description:

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

Treatment:

Procedure: Intradiscal PRP & BMC Injections

Platelet Rich Plasma Injection

Active Comparator group

Description:

The Platelet Rich Plasma group will receive an injection of approximately 1-2 mL of Platelet Rich Plasma into the painful disc/discs.

Treatment:

Procedure: Intradiscal PRP & BMC Injections

Bone Marrow Aspirate Injection

Active Comparator group

Description:

The third group will receive an injection of approximately 1-2 mL of Bone Marrow Concentrate into the painful disc/discs.

Treatment:

Procedure: Intradiscal PRP & BMC Injections