170 Participants Needed

PRP Injections for Low Back Pain

Recruiting at 1 trial location
SS
CS
Overseen ByCarolyn Smith
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Womack Army Medical Center
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on opioid medication greater than or equal to 50 MME, you cannot participate in the trial.

What data supports the effectiveness of the treatment Platelet Rich Plasma (PRP) for low back pain?

Research suggests that PRP, which contains growth factors that may help heal tissues and reduce inflammation, has shown promise in improving conditions related to low back pain, particularly in cases involving disc degeneration.12345

Is PRP generally safe for humans?

PRP (Platelet Rich Plasma) is generally considered safe, with adverse reactions being extremely rare.26789

How is PRP treatment different from other treatments for low back pain?

PRP (Platelet-Rich Plasma) treatment is unique because it uses a patient's own blood components, specifically platelets, which are rich in growth factors that may promote healing and reduce inflammation. Unlike standard treatments that often only relieve symptoms, PRP aims to regenerate and restore the function of damaged tissues in the spine.23457

What is the purpose of this trial?

Low back pain (LBP) is both the single most common cause of disability and the leading cause of visits when military personnel go to their primary care doctors. Military personnel that deal with LBP can often be placed on limited duty profile. Not surprisingly, the direct and indirect costs of low back and neck pain accounts for approximately $88 billion of health care expenditure. In order to reduce the large financial and personal cost, clinical studies must be designed to treat LBP. This study will provide evidence-based medicine on a new regenerative medicine treatment option that may significantly affect military personnel with LBP. PRP (Platelet Rich Plasma) may offer alternate treatment methods that may help preserve the facet joint structures, and improve pain and function without causing destructive lesions or worsening degenerative joints. This healing process may favor improved participation with rehabilitation therapy and ultimately improve return to duty status. This study will also assess the effectiveness of point of care generated PRP, as a minimally invasive treatment option for treating lumbar facet pain. Specifically, PRP effectiveness will be compared to injecting placebo control when injected into facet joints.

Research Team

MH

Min Ho Chang, MD

Principal Investigator

Womack Army Medical Center

Eligibility Criteria

This trial is for military personnel aged 18-75 with chronic low back pain lasting over 3 months, who have not had recent spinal interventions or lumbar fusion, and are not on high opioid doses. Participants must speak English, be DEERS eligible, and able to consent. They should have a positive response to a diagnostic block injection but can't join if they're pregnant, moving soon, or have certain medical conditions.

Inclusion Criteria

DEERS eligible
My main pain area is in my lower back.
I have had lower back pain for over 3 months.
See 3 more

Exclusion Criteria

I have had surgery to join two or more vertebrae in my lower back.
I have had spinal treatments like steroid injections for my current symptoms.
I have had a procedure to treat back pain by targeting nerves.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

8-12 weeks
1 visit (in-person)

Treatment

Participants receive either PRP or placebo injection into the lumbar facet joint

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
3 visits (in-person) at 1, 3, and 6 months post-injection

Optional PRP Extension for Control Group

Control group participants may opt to receive PRP injection at 3 months and continue follow-up

3 months
2 visits (in-person) at 3 and 6 months post-PRP injection

Treatment Details

Interventions

  • Platelet Rich Plasma
Trial Overview The study tests Platelet Rich Plasma (PRP) injections as a treatment for lower back pain by comparing its effectiveness against placebo control injections. PRP aims to preserve joint structures and improve pain without causing further damage. The goal is better rehabilitation outcomes and return-to-duty status for military personnel.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Platelet Rich Plasma injection to lumbar facet jointExperimental Treatment1 Intervention
Platelet Rich Plasma injection to lumbar facet joint
Group II: Placebo injection to lumbar facet jointPlacebo Group1 Intervention
Placebo injection to lumbar facet joint

Platelet Rich Plasma is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Platelet Rich Plasma for:
  • Facet-mediated lumbar low back pain
  • Degenerative joint disease
  • Chronic pain
🇪🇺
Approved in European Union as Platelet Rich Plasma for:
  • Orthopedic conditions
  • Musculoskeletal disorders
  • Pain management

Find a Clinic Near You

Who Is Running the Clinical Trial?

Womack Army Medical Center

Lead Sponsor

Trials
22
Recruited
17,100+

The Geneva Foundation

Collaborator

Trials
39
Recruited
13,700+

Uniformed Services University of the Health Sciences

Collaborator

Trials
130
Recruited
91,100+

Findings from Research

Platelet-rich plasma (PRP) injections have been found to be generally effective and safe for managing low back pain (LBP), with 11 out of 13 randomized clinical trials showing positive results compared to control groups.
The systematic review included 13 RCTs and 27 non-randomized trials or case series, indicating a high compliance rate in PRP preparation methods, but highlights the need for larger, multicenter trials to further validate these findings.
Systematic Review of Platelet-Rich Plasma for Low Back Pain.Machado, ES., Soares, FP., Vianna de Abreu, E., et al.[2023]
Platelet-rich plasma (PRP) has shown promise in treating discogenic low back pain (DLBP) by promoting the regeneration of intervertebral disc cells and alleviating pain, as supported by various in vitro and in vivo studies.
While PRP is generally considered effective and safe, with advantages like low immunological rejection and ease of preparation, some studies report conflicting results, indicating a need for further research to optimize PRP methods and establish long-term effectiveness.
[Research progress of platelet-rich plasma in treatment of discogenic low back pain].Huang, H., Wang, J., Liu, X., et al.[2023]
Intradiscal platelet-rich plasma (PRP) injections show strong in vitro evidence and promising results in animal studies for treating discogenic low back pain.
A clinical study involving 29 participants demonstrated significant improvements in pain and function for up to two years after receiving intradiscal PRP injections, suggesting it is a safe and potentially effective treatment option.
Intradiscal platelet-rich plasma (PRP) injections for discogenic low back pain: an update.Monfett, M., Harrison, J., Boachie-Adjei, K., et al.[2019]

References

Systematic Review of Platelet-Rich Plasma for Low Back Pain. [2023]
[Research progress of platelet-rich plasma in treatment of discogenic low back pain]. [2023]
Intradiscal platelet-rich plasma (PRP) injections for discogenic low back pain: an update. [2019]
Intradiscal Autologous Platelet-Rich Plasma Injection for Discogenic Low Back Pain: A Clinical Trial. [2022]
Platelet-Rich Plasma for the Treatment of Low Back Pain: a Comprehensive Review. [2020]
Serum sickness disease in a patient with alopecia areata and Meniere' disease after PRP procedure. [2019]
Intradiscal Platelet-Rich Plasma Injection for Discogenic Low Back Pain and Correlation with Platelet Concentration: A Prospective Clinical Trial. [2021]
Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. [2018]
Plasma Rich in Growth Factors (PRGF) in the Treatment of Cervical and Lumbar Back Pain: A Retrospective Observational Clinical Study. [2021]
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