PRP vs Corticosteroids vs Lidocaine for Joint Pain

Recruiting at 1 trial location

Overseen By Rachel Mayhew, DPT

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Brooke Army Medical Center

Disqualifiers: Recent injections, Severe AC separation, Systemic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

34 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will compare three different treatment injections for the management of acromioclavicular joint dysfunction (ACJ Dysfunction). Patients that consent and enroll will be randomized to receive (1) a corticosteroid injection, (2) an injection of Platelet Rich Plasma, or (3) a Lidocaine injection. Follow-up will occur over a 1 year period.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you've had any injections or surgery for the affected shoulder in the last year, you cannot participate.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have had any injections or surgery for the affected shoulder in the last year, you would not be eligible to participate.

What data supports the idea that PRP vs Corticosteroids vs Lidocaine for Joint Pain is an effective treatment?

The available research shows that both PRP and corticosteroid injections are effective in reducing pain, stiffness, and improving function in patients with knee osteoarthritis for up to six months. In a study comparing these treatments, both showed similar improvements, with no significant difference between them. Another study on de Quervain's tenosynovitis found that both PRP and corticosteroid injections were equally effective in reducing symptoms, but PRP had fewer complications. This suggests that while both treatments work well, PRP might have a slight advantage in terms of safety. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment for joint pain?

Research shows that both PRP (platelet-rich plasma) and corticosteroid injections are effective in reducing pain and improving function in conditions like knee osteoarthritis and de Quervain's tenosynovitis. PRP may have fewer side effects compared to corticosteroids, but both treatments show similar effectiveness in managing symptoms. ^{1 2 3 4 5}

What safety data exists for PRP, corticosteroid, and lidocaine injections for joint pain?

The safety data for PRP and corticosteroid injections indicate that both treatments are generally safe and effective for joint pain, with some differences in complication profiles. PRP injections have been associated with fewer complications compared to corticosteroid injections, which can cause side effects like subcutaneous fat atrophy, depigmentation, and temporary pain increase. No major complications were reported for PRP in the studies reviewed. Lidocaine, often used as a local anesthetic, is not specifically addressed in the provided studies, but it is generally considered safe for local use in medical procedures. Further research, particularly long-term studies, is needed to fully understand the safety profiles of these treatments. ^{2 5 6 7 8}

Is it safe to use PRP, corticosteroids, or lidocaine injections for joint pain?

Research shows that both PRP and corticosteroid injections are generally safe for treating joint pain, with PRP possibly having fewer complications. Some studies reported minor issues like temporary pain increase with corticosteroids, but no major complications were noted for either treatment. ^{2 5 6 7 8}

Is the treatment Corticosteroid Injection, Lidocaine injection, Protein Rich Plasma (PRP) Injection promising for joint pain?

Yes, both corticosteroid and PRP injections are promising treatments for joint pain. They are effective in reducing pain and improving function in conditions like knee osteoarthritis and lumbar spondylosis. PRP may offer longer-lasting benefits and fewer complications compared to corticosteroids. ^{1 2 4 5 7}

How does the treatment of PRP, corticosteroids, and lidocaine for joint pain differ from other treatments?

PRP (Platelet-Rich Plasma) injections are unique because they use components from your own blood to promote healing and have anti-inflammatory effects, potentially offering longer-lasting relief compared to corticosteroids, which are synthetic drugs that reduce inflammation but may have more side effects. Lidocaine is a local anesthetic that provides temporary pain relief by numbing the area, unlike PRP and corticosteroids, which aim to address the underlying inflammation. ^{1 2 4 5 7}

Research Team

Daniel Rhon, DSc

Principal Investigator

Uniformed Services University of the Health Sciences

Eligibility Criteria

This trial is for TRICARE beneficiaries aged 18-65 with AC joint pain, who can consent in English and have tenderness or pain during specific tests. Excluded are those with recent invasive shoulder treatments, leaving the military soon, systemic diseases like rheumatoid arthritis, shoulder infections/fractures/dislocations, severe AC Joint separations (Grades III-VI), or allergies to corticosteroids.

Inclusion Criteria

I am eligible for TRICARE and have pain in my AC joint.

Able to speak and read English well enough to provide informed consent, follow study instructions and independently answer the questionnaires/surveys

If certain movements or exercises cause the same pain you're seeking treatment for.

Exclusion Criteria

Anyone separating from the military within 10 months (other than normal military retirement), pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury

I have frozen shoulder in the same shoulder that is affected.

You have had a bad reaction to corticosteroid medication in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three injection therapies: corticosteroid, platelet-rich plasma, or lidocaine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Multiple visits at 1, 2, 3, 4, 5, 6, and 12 months post-enrollment

Treatment Details

Interventions

• Corticosteroid Injection
• Lidocaine injection
• Protein Rich Plasma(PRP) Injection

Trial Overview The study compares three injections for ACJ Dysfunction: a corticosteroid injection to reduce inflammation; Platelet Rich Plasma (PRP) which uses patient's own blood components to promote healing; and Lidocaine, a local anesthetic for pain relief. Participants will be randomly assigned one of these treatments and followed up over a year.

Participant Groups

Group I: Lidocaine Active Control 1 Intervention

50 Subjects will be randomized to this group and will receive a lidocaine injection in their ACJ.

Group II: Corticosteroid Active Control 1 Intervention

50 Subjects will be randomized to this group and will receive a corticosteroid injection in their ACJ.

Group III: Platelet Rich Plasma (PRP) Active Control 1 Intervention

50 Subjects will be randomized to this group and will receive a PRP injection in their ACJ.

Corticosteroid Injection is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Corticosteroid injection for:

• Acromioclavicular joint pain
• Shoulder impingement syndrome
• Rotator cuff disease
• Adhesive capsulitis
• Glenohumeral osteoarthritis

Approved in United States as Corticosteroid injection for:

• Acromioclavicular joint pain
• Shoulder impingement syndrome
• Rotator cuff disease
• Adhesive capsulitis
• Glenohumeral osteoarthritis

Approved in Canada as Corticosteroid injection for:

• Acromioclavicular joint pain
• Shoulder impingement syndrome
• Rotator cuff disease
• Adhesive capsulitis
• Glenohumeral osteoarthritis

Who Is Running the Clinical Trial?

Brooke Army Medical Center

Lead Sponsor

Trials

134

Recruited

28,100+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

The Geneva Foundation

Collaborator

Trials

39

Recruited

13,700+

Madigan Army Medical Center

Collaborator

Trials

52

Recruited

17,600+

Findings from Research

In a study involving 29 patients with bilateral knee osteoarthritis, both platelet-rich plasma (PRP) and corticosteroid injections were found to effectively improve pain, stiffness, and function over a six-month period.

While PRP showed slightly better results than corticosteroids at the six-month mark, there was no statistically significant difference between the two treatments, indicating that both are viable options for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-Blind Randomized Controlled Trial Comparing Platelet-Rich Plasma With Intra-Articular Corticosteroid Injections in Patients With Bilateral Knee Osteoarthritis. Pretorius, J., Nemat, N., Alsayed, A., et al.[2022]

In a study of 60 patients with de Quervain's tenosynovitis, both platelet-rich plasma (PRP) and corticosteroid injections showed significant improvement in symptoms, but there was no statistical difference in effectiveness between the two treatments.

PRP injections had a lower complication rate compared to corticosteroids, which had a 26.67% complication rate including issues like fat atrophy and increased pain, suggesting PRP may be a safer option despite its higher cost and preparation time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Clinical and Functional Outcomes after Platelet-Rich Plasma Injection and Corticosteroid Injection for the Treatment of de Quervain's Tenosynovitis. Kumar, V., Talwar, J., Rustagi, A., et al.[2023]

Intra-articular platelet-rich plasma (PRP) injections significantly relieve pain in knee osteoarthritis compared to saline and corticosteroid injections, with a large effect size indicating clinical importance.

There was no significant difference in effectiveness between leukocyte-poor PRP (LP-PRP) and leukocyte-rich PRP (LR-PRP), suggesting both types may be similarly beneficial, but further high-quality studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Clinical Trials. Nie, LY., Zhao, K., Ruan, J., et al.[2022]

Autologous blood injections (ABIs) are more effective than corticosteroid injections for alleviating pain and disability in patients with tennis elbow, showing benefits in both the short and long term.

While platelet-rich plasma (PRP) injections also reduce pain, the improvement is not considered clinically meaningful compared to the effects of ABIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do autologous blood and PRP injections effectively treat tennis elbow? Widstrom, L., Slattengren, A.[2018]

Corticosteroid injections effectively modulate inflammation and maintain synovial homeostasis in shoulder pain, as shown by their regulation of pro-inflammatory and anti-inflammatory cytokines.

When combined with platelet-rich plasma (PRP), corticosteroids enhance the regulation of certain inflammatory markers without interfering with the corticosteroid's effects, suggesting a synergistic benefit in treating inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of corticosteroids and platelet-rich plasma on synoviocytes in IL-1ß-induced inflammatory condition. Yea, JH., Shin, S., Yoon, KS., et al.[2022]

Intra-articular platelet-rich plasma (PRP) injections significantly reduce symptoms of knee osteoarthritis (OA) compared to corticosteroid (CS) injections, showing the greatest improvement at 6 and 9 months post-treatment in a review of 8 studies involving 648 patients.

Triple PRP injections, spaced a week apart, are more effective than a single injection, leading to better pain management, reduced stiffness, and improved ability to participate in sports activities over a 12-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular platelet-rich plasma injections versus intra-articular corticosteroid injections for symptomatic management of knee osteoarthritis: systematic review and meta-analysis. McLarnon, M., Heron, N.[2021]

A systematic review of five studies involving 242 patients found that both platelet-rich plasma (PRP) and corticosteroid injections are safe and effective treatments for lumbar spondylosis and sacroiliac arthropathy, with no major complications reported.

At long-term follow-up (three to six months), PRP injections showed more significant improvements in clinical outcomes compared to corticosteroids, suggesting that PRP may be a more effective option for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma Versus Corticosteroid Injection for Lumbar Spondylosis and Sacroiliac Arthropathy: A Systematic Review of Comparative Studies. Ling, JF., Wininger, AE., Hirase, T.[2023]

In a study of 25 patients with recalcitrant lateral epicondylar tendinopathy, leukocyte-poor (type-4B) platelet-rich plasma (PRP) injections showed significant long-term improvements in pain and elbow function compared to bupivacaine injections, particularly noticeable at 6 months and 1 year.

While bupivacaine provided quicker initial relief, the PRP group demonstrated greater overall improvement in pain and function over time, suggesting that PRP may be a more effective long-term treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leukocyte-poor platelet-rich plasma versus bupivacaine for recalcitrant lateral epicondylar tendinopathy. Behera, P., Dhillon, M., Aggarwal, S., et al.[2022]

References

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

Double-Blind Randomized Controlled Trial Comparing Platelet-Rich Plasma With Intra-Articular Corticosteroid Injections in Patients With Bilateral Knee Osteoarthritis. [2022]

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

Comparison of Clinical and Functional Outcomes after Platelet-Rich Plasma Injection and Corticosteroid Injection for the Treatment of de Quervain's Tenosynovitis. [2023]

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

Effectiveness of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Clinical Trials. [2022]

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

Do autologous blood and PRP injections effectively treat tennis elbow? [2018]

5. England pubmed.ncbi.nlm.nih.gov

Effects of corticosteroids and platelet-rich plasma on synoviocytes in IL-1ß-induced inflammatory condition. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Intra-articular platelet-rich plasma injections versus intra-articular corticosteroid injections for symptomatic management of knee osteoarthritis: systematic review and meta-analysis. [2021]

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

Platelet-Rich Plasma Versus Corticosteroid Injection for Lumbar Spondylosis and Sacroiliac Arthropathy: A Systematic Review of Comparative Studies. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Leukocyte-poor platelet-rich plasma versus bupivacaine for recalcitrant lateral epicondylar tendinopathy. [2022]