34 Participants Needed

PRP vs Corticosteroids vs Lidocaine for Joint Pain

Recruiting at 1 trial location
RM
Overseen ByRachel Mayhew, DPT
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Brooke Army 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

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.12345

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.12345

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.25678

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.25678

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.12457

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.12457

Research Team

DR

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.
See 1 more

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.
See 3 more

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 OverviewThe 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
3Treatment groups
Active Control
Group I: LidocaineActive Control1 Intervention
50 Subjects will be randomized to this group and will receive a lidocaine injection in their ACJ.
Group II: CorticosteroidActive Control1 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 Control1 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

Find a Clinic Near You

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.
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.
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.
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]

References

Double-Blind Randomized Controlled Trial Comparing Platelet-Rich Plasma With Intra-Articular Corticosteroid Injections in Patients With Bilateral Knee Osteoarthritis. [2022]
Comparison of Clinical and Functional Outcomes after Platelet-Rich Plasma Injection and Corticosteroid Injection for the Treatment of de Quervain's Tenosynovitis. [2023]
Effectiveness of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Clinical Trials. [2022]
Do autologous blood and PRP injections effectively treat tennis elbow? [2018]
Effects of corticosteroids and platelet-rich plasma on synoviocytes in IL-1ß-induced inflammatory condition. [2022]
Intra-articular platelet-rich plasma injections versus intra-articular corticosteroid injections for symptomatic management of knee osteoarthritis: systematic review and meta-analysis. [2021]
Platelet-Rich Plasma Versus Corticosteroid Injection for Lumbar Spondylosis and Sacroiliac Arthropathy: A Systematic Review of Comparative Studies. [2023]
Leukocyte-poor platelet-rich plasma versus bupivacaine for recalcitrant lateral epicondylar tendinopathy. [2022]