PRP Injections for Low Back Pain

No longer recruiting at 1 trial location

Overseen By Carolyn Smith

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Womack Army Medical Center

Must not be taking: Opioids

Disqualifiers: Spinal pathology, Uncontrolled depression, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Platelet Rich Plasma (PRP) injections to determine if it can alleviate low back pain and improve function without harming the joints. The study focuses on military personnel with chronic low back pain, aiming to provide evidence on whether this minimally invasive option is more effective than a placebo. It suits those who have experienced significant low back pain for over three months and endure substantial daily discomfort. Participants should also have experienced a notable reduction in pain after a specific diagnostic procedure. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for chronic low back pain.

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.

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

Research shows that Platelet Rich Plasma (PRP) injections are generally safe for treating low back pain. Studies have found PRP to be an effective and well-tolerated alternative to traditional treatments. For instance, one study found that using PRP in the lower back did not cause significant negative side effects. Another review noted that PRP treatment can be a safe option with fewer risks than some other therapies, such as medications or more invasive procedures.

In short, while side effects can occur with any treatment, research indicates that PRP injections are considered safe for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for low back pain, such as physical therapy, pain medications, or steroid injections, Platelet Rich Plasma (PRP) injections are derived from a patient's own blood. Researchers are excited about PRP because it uses the body's natural healing processes, potentially offering a regenerative approach rather than just symptom relief. PRP is injected directly into the lumbar facet joint, targeting the source of pain and inflammation. This method may provide longer-lasting results compared to conventional therapies by promoting tissue repair and reducing the reliance on medications.

What evidence suggests that PRP injections might be an effective treatment for low back pain?

Research has shown that Platelet Rich Plasma (PRP) injections can reduce pain and improve healing in lower back joint problems. PRP is rich in growth factors that repair tissues and reduce inflammation. Some studies have found PRP to be as effective as corticosteroids for short-term pain relief. Other research indicates that PRP treatments can improve low back pain and related disability for up to five to nine years. In this trial, participants will receive either a PRP injection or a placebo injection to the lumbar facet joint. In the short term, PRP injections are considered safe and effective, often reducing pain within a few weeks and lasting for several months. Overall, PRP offers a promising alternative for treating low back pain without worsening joint issues. ^{3 5 6 7 8}

Who Is on the Research Team?

Min Ho Chang, MD

Principal Investigator

Womack Army Medical Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Platelet Rich Plasma injection to lumbar facet joint Experimental Treatment 1 Intervention

Platelet Rich Plasma injection to lumbar facet joint

Group II: Placebo injection to lumbar facet joint Placebo Group 1 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

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+

Published Research Related to This Trial

A single intradiscal injection of platelet-rich plasma (PRP) significantly improved pain and lumbar function in 31 patients with discogenic low back pain (DLBP) over a 48-week follow-up period, with 71% of patients classified as treatment successes.

The study reported a high follow-up rate of 94%, but noted one case of intervertebral discitis requiring surgery, indicating the need for further randomized controlled trials to fully assess the safety and efficacy of PRP injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intradiscal Autologous Platelet-Rich Plasma Injection for Discogenic Low Back Pain: A Clinical Trial. Zhang, J., Liu, D., Gong, Q., et al.[2022]

A 41-year-old woman developed serum sickness disease (SSD) after her third platelet rich plasma (PRP) treatment for alopecia areata, highlighting a rare but serious adverse reaction to this generally safe procedure.

The case suggests that individuals with active autoimmune diseases, like alopecia areata, may face increased risks from PRP treatments, indicating that such conditions should be considered as significant contraindications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum sickness disease in a patient with alopecia areata and Meniere' disease after PRP procedure. Owczarczyk-Saczonek, A., Wygonowska, E., Budkiewicz, M., et al.[2019]

In a study involving 25 patients with discogenic pain, those who received intradiscal platelet-rich plasma (PRP) injections showed significant improvement in pain and functional status, with 20 patients completing the study.

The effectiveness of PRP treatment was positively correlated with platelet concentration, indicating that higher platelet counts in the PRP samples led to better reductions in pain and disability scores at both three and six months post-injection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intradiscal Platelet-Rich Plasma Injection for Discogenic Low Back Pain and Correlation with Platelet Concentration: A Prospective Clinical Trial. Jain, D., Goyal, T., Verma, N., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Research progress of platelet-rich plasma in treatment of discogenic low back pain]. Huang, H., Wang, J., Liu, X., et al.[2023]

In a retrospective study of 65 patients with cervical and lumbar spine pain, treatment with plasma rich in growth factors (PRGF) showed statistically significant improvements in pain and disability scores, indicating its effectiveness as a minimally invasive treatment option.

Out of 252 cases analyzed, 62% demonstrated a statistically significant improvement post-treatment, suggesting that PRGF infiltrations can be a beneficial biological strategy for managing chronic spine pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma Rich in Growth Factors (PRGF) in the Treatment of Cervical and Lumbar Back Pain: A Retrospective Observational Clinical Study. Kirchner, F., Milani, I., Martinez, A., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of Platelet-Rich Plasma for Low Back Pain. Machado, ES., Soares, FP., Vianna de Abreu, E., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intradiscal platelet-rich plasma (PRP) injections for discogenic low back pain: an update. Monfett, M., Harrison, J., Boachie-Adjei, K., et al.[2019]

Autologous plasma rich in platelets (PRP) has shown to improve gingival recession in chronic periodontitis, with a significant effect size (SMD of 0.54) based on data from four randomized controlled trials.

The efficacy of PRP in promoting complete healing of chronic skin ulcers remains inconclusive, and while adverse effects were reported, there were no significant differences between treatment groups, indicating a need for further research on its safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. Martínez-Zapata, MJ., Martí-Carvajal, A., Solà, I., et al.[2018]

Platelet-rich plasma (PRP) injections have shown promise as a relatively safe treatment for degenerative disc disease in patients who have not found relief from other treatments, based on recent studies.

While PRP may provide some benefits for conditions like facet joint arthropathy, more research is needed to establish its efficacy and safety for various causes of chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma for the Treatment of Low Back Pain: a Comprehensive Review. Urits, I., Viswanath, O., Galasso, AC., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9329057/

Platelet-Rich Plasma in the Treatment of Facet Mediated ... PRP has been used autogenously to decrease pain and enhance the healing process via many growth factors. PRP is a concentration of inflammatory ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10934062/

Injections of Platelet-Rich Plasma: An Emerging Novel ... The outcomes of the study showed that both LR-PRP corticosteroid therapies showed similar levels of safety and effectiveness when used to treat ...

3. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/141416-platelet-rich-plasma-for-the-therapy-of-the-lumbar-facet-joint-syndrome-a-prospective-study-about-ct-guided-facet-joint-injections-with-prp-compared

Platelet Rich Plasma for the Therapy of the Lumbar Facet ... Data analysis revealed that both, PRP and local anesthetics had a pain reducing effect initially at week 2 after receiving the first PAT, but ...

4. mdpi.com mdpi.com/1422-0067/24/8/7677

Advances in Platelet-Rich Plasma Treatment for Spinal ... Both studies reported that the treatments had a safe and efficacious impact on improving LBP and LBP-related disability during the five to nine years of follow- ...

5. painphysicianjournal.com painphysicianjournal.com/current/pdf?article=MzEwOQ%3D%3D&journal=100

A New Technique for the Treatment of Lumbar Facet Joint ... Conclusions: In the short-term period of 3 months, the new technique of lumbar facet joint injection with autologous PRP is effective and safe for patients with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10525951/

Systematic Review of Platelet-Rich Plasma for Low Back Pain Safety and Efficacy of Platelet Rich Plasma for Treatment ... Lumbar Facet Joint Syndrome Using Intra-articular Injection with Autologous Platelet Rich Plasma.

7. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/37076-platelet-rich-plasma-in-the-treatment-of-facet-mediated-low-back-pain-a-comprehensive-review

Platelet-Rich Plasma in the Treatment of Facet Mediated ... PRP injections for facet mediated or modulated pain are an alternative to conventional pharmacotherapies and interventional injections/radiofrequency.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02983747

Autologous Platelet Rich Plasma on Low Back Pain An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...