PRP Injections for Low Back Pain

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

170 Participants Needed

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. ^{1 2 3 4 5}

Is PRP generally safe for humans?

PRP (Platelet Rich Plasma) is generally considered safe, with adverse reactions being extremely rare. ^{2 6 7 8 9}

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. ^{2 3 4 5 7}

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

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.

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

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

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+

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.

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Systematic Review of Platelet-Rich Plasma for Low Back Pain. [2023]

2. China pubmed.ncbi.nlm.nih.gov

[Research progress of platelet-rich plasma in treatment of discogenic low back pain]. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Intradiscal platelet-rich plasma (PRP) injections for discogenic low back pain: an update. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Intradiscal Autologous Platelet-Rich Plasma Injection for Discogenic Low Back Pain: A Clinical Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma for the Treatment of Low Back Pain: a Comprehensive Review. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Serum sickness disease in a patient with alopecia areata and Meniere' disease after PRP procedure. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Intradiscal Platelet-Rich Plasma Injection for Discogenic Low Back Pain and Correlation with Platelet Concentration: A Prospective Clinical Trial. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. [2018]

9. United States 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. [2021]