PRP vs NP Injections for Low Back Pain

ED
MS
Overseen ByMarin Smith
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Walter Reed National Military Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different injections to help people with chronic low back pain originating from spinal discs. One injection uses a person's own blood, known as platelet-rich plasma (PRP), to heal and reduce back pain. The other uses a gel-like material from a donor's spinal disc, called nucleus pulposus (NP), which aims to restore spinal cushioning. Participants will receive one of these injections and will not know which one until six months after the procedure. The trial seeks individuals who have experienced low back pain for over three months, have not undergone back surgery, and have tried other treatments without success. As a Phase 2, Phase 3 trial, this study measures the treatments' effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in back pain treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that platelet-rich plasma (PRP) injections are generally safe for treating low back pain. A thorough review found that unwanted side effects with PRP occur relatively infrequently. PRP carries fewer risks and side effects compared to steroids and is safe for ongoing use.

For the nucleus pulposus (NP) injection, studies suggest it is also safe. One study reported 51 side effects across several groups, with only 12% being serious. This indicates that most side effects are not severe.

Both treatments appear well-tolerated, with most side effects being mild. Prospective trial participants can be reassured that both options have demonstrated a good safety record in past research.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for low back pain because they offer innovative approaches compared to standard options like physical therapy, NSAIDs, or corticosteroid injections. The platelet-rich plasma (PRP) injection is unique because it uses a concentration of a patient's own platelets, which might promote healing and reduce inflammation directly at the site of pain. The nucleus pulposus (NP) injection is distinctive as it involves a tissue graft that could potentially repair and restore the affected discs in the spine. These treatments target the root causes of low back pain rather than just managing symptoms, which is why there is a lot of anticipation around their potential effectiveness.

What evidence suggests that this trial's treatments could be effective for low back pain?

This trial will compare the effectiveness of platelet-rich plasma (PRP) injections and nucleus pulposus (NP) injections for treating low back pain. Research has shown that PRP injections can help treat low back pain, with one study reporting that 71% of patients experienced significant pain relief and improved function after 48 weeks. Another study suggested that PRP may provide longer-lasting benefits than steroids, with a success rate of 60% to 75% for lower back pain.

For NP injections, research has also shown positive results. Specifically, one study found that 64% of patients had more than a 50% reduction in back pain, with relief lasting at least 24 months. Another study reported a 43% reduction in back pain severity after 12 months. Both treatments in this trial aim to reduce pain and improve function for people with chronic low back pain.26789

Are You a Good Fit for This Trial?

This trial is for adults with chronic low back pain coming from their spinal discs who haven't improved after trying other treatments, have not had back surgery before, and haven't received any spine injections in the past year.

Inclusion Criteria

I agree to only have disc injections and no new back treatments for 6 months, except therapy or exercise.
I have had low back pain for more than 3 months.
My average pain level has been 4 or higher out of 10 this past week.
See 9 more

Exclusion Criteria

Inability to stop Schedule 2 opioid use within 1 month of enrollment due to chronic pain
Individuals at risk to require systemic steroids over the 6-month study course such as those with poorly controlled asthma, COPD, or autoimmune disease
I have had low back pain for more than 15 years.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either PRP or NP injections to treat chronic discogenic low back pain

6 months
5-6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Nucleus Pulposus (NP) Injection
  • Platelet-Rich Plasma (PRP) Injection

Trial Overview

The study compares two injection treatments: one uses a person's own concentrated blood platelets (PRP), and the other uses donor disc tissue (NP). Participants are randomly assigned to receive one of these injections and will be followed for 6 months.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Intradiscal Autologous Platelet-Rich Plasma (PRP) InjectionActive Control1 Intervention
Group II: Intradiscal Allogeneic Nucleus Pulposus (NP) Tissue Graft InjectionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Walter Reed National Military Medical Center

Lead Sponsor

Trials
149
Recruited
33,800+

Uniformed Services University of the Health Sciences

Collaborator

Trials
130
Recruited
91,100+

Citations

VIA Disc Nucleus Pulposus Older Patients Pilot

VIA Disc NP is a non-surgical intervention intended to supplement the nucleus pulposus tissue in degenerated intervertebral discs.

Safety Evaluation of Intradiscal Delivery of Nucleus ...

The current study evaluates adverse events (AEs) and safety outcomes following intradiscal administra- tion of VIA Disc NP, a human NP allograft ...

Minimally invasive disc injection reduces pain and ...

Study participants experienced a 43% reduction in back pain severity from baseline to 12 months. Numeric Rating Scale (NRS) scores, a self- ...

Via Disc NP: A New Non-Surgical Treatment for Lumbar ...

Via Disc NP is a nucleus pulposus allograft intended to restore a patient's degenerated lumbar disc. The treatment is non-surgical and ...

5.

spinewellnessamerica.com

spinewellnessamerica.com/via-disc-np/

VIA Disc NP

VIA Disc NP is intended to replace nucleus pulposus tissue loss in patients due to the degeneration of the intervertebral discs. VIA Disc NP is an option for ...

Efficacy, Safety, and Predictors of Intradiscal... : Pain Practice

Pain treatment at 6 months was successful in 40% of patients, with at least 30% pain reduction in 6 patients (more than 50% in 5 patients).

Nucleus Pulposus Allograft Supplementation in Patients ...

Academic and private practice outpatient clinics was achieved in 79% (22 of 28) and 68% (19 of 28) of patients for ODI and NRS-11, respectively.

Responsible, Safe, and Effective Use of Biologics in the ...

Objective: To provide guidance for the responsible, safe, and effective use of biologic therapy in the lumbar spine. To present a template on which to build ...

Pain Management Injection Therapies for Low Back Pain

For studies of interventions, we calculated relative risks and associated 95 percent confidence intervals (CI) Epidural corticosteroid ...