PRP vs Corticosteroids vs Lidocaine for Joint Pain

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores three injection treatments to determine their effectiveness in managing pain in the acromioclavicular joint (ACJ), a common source of shoulder pain. Participants will receive a random assignment to either a corticosteroid injection, platelet-rich plasma (PRP) injection, or lidocaine injection. The study aims to identify which treatment works best over the course of a year. Ideal participants have ACJ pain triggered by touch or certain movements and have not received similar treatments or surgery for this issue in the past year. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, aiming to understand how they benefit more patients.

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 is the safety track record for these treatments?

Earlier research found corticosteroid injections generally safe for joint pain, though they might cause some joint damage over time. Another study suggested no major increase in joint damage risk compared to other treatments. However, limiting these injections to no more than once every three months per joint is advised.

Research shows that lidocaine injections, which numb the area and reduce pain, are well-tolerated. No major negative effects have been reported. Minor issues, like local pain or headache, might occur but are temporary.

Studies have shown that platelet-rich plasma (PRP) injections are also safe for treating joint problems. Some people might experience mild side effects like infections, but these are uncommon. PRP may help reduce pain and improve movement for those with joint issues.

Overall, previous studies have shown all three treatments to be safe, but each has different possible side effects and benefits.12345

Why are researchers enthusiastic about this study's treatments?

Researchers are excited about these treatments for joint pain because they offer different approaches compared to traditional options. Corticosteroid injections are known for their anti-inflammatory effects, providing rapid relief by reducing swelling. Lidocaine injections act as local anesthetics, offering immediate pain relief by numbing the area. Platelet Rich Plasma (PRP) injections are unique because they use components of your own blood to potentially promote healing and tissue regeneration. This regenerative approach could offer longer-lasting benefits compared to temporary pain relief from standard treatments. Each of these treatments brings something distinct to the table, providing a range of options for managing joint pain.

What evidence suggests that this trial's treatments could be effective for ACJ Dysfunction?

Research has shown that lidocaine injections, one of the treatments in this trial, can relieve joint pain, with 83% of patients experiencing some pain reduction. Another treatment option, corticosteroid injections, provides moderate short-term pain relief, with a 47% success rate in improving shoulder function and quality of life over a year. Studies have found that PRP (Platelet Rich Plasma) injections, also tested in this trial, significantly improve pain and function, with a 60% to 70% success rate and relief lasting from 6 to 12 months. Each treatment offers distinct benefits, and the choice may depend on individual needs and desired duration of relief.678910

Who Is on the Research Team?

DR

Daniel Rhon, DSc

Principal Investigator

Uniformed Services University of the Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Active Control
Group I: LidocaineActive Control1 Intervention
Group II: CorticosteroidActive Control1 Intervention
Group III: Platelet Rich Plasma (PRP)Active Control1 Intervention

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

🇪🇺
Approved in European Union as Corticosteroid injection for:
🇺🇸
Approved in United States as Corticosteroid injection for:
🇨🇦
Approved in Canada as Corticosteroid injection for:

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+

Published Research Related to This Trial

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

Citations

Mid- to long-term success rate and functional outcomes of ...AC injections offer a 1-year success rate of 47%. The AC injection produces good mid- to long-term clinical outcomes regarding shoulder function, quality of ...
Use and safety of corticosteroid injections in joints and ...Overall, IACS injections result in short-term pain relief from a few weeks to a few months. The adverse events include an increase in blood ...
Clinical Trial The most effective corticosteroid dose in ...The authors concluded that the 2 steroid doses yielded similar improvements when measuring the Shoulder Pain and Disability Index (SPADI), visual analog score, ...
Cell-based versus corticosteroid injections for knee pain in ...This study shows that at 1 year post injection, there was no superior orthobiologic as compared to CSI for knee osteoarthritis.
Corticosteroids: Review of the History, the Effectiveness, ...Results: The current evidence would suggest that the use of corticosteroids provides moderate short-term benefit for reducing pain and ...
Evidence suggests that intraarticular corticosteroids are ...Combining data from the MOST and OAI studies, Bucci et al. reported that patients undergoing steroid injections had no greater risk of OA progression nor of ...
Knee Arthritis Made Worse with Steroid InjectionsThe study found that corticosteroid injections led to more knee joint damage over the two-year period than both the control group and those who ...
Use and safety of corticosteroid injections in joints and ...This guideline focuses on the safety and efficacy of corticosteroid joint injections for managing joint chronic pain in adults.
Debate: Intra-articular steroid injections for osteoarthritisSystematic reviews show that the treatment effect is modest compared with intra-articular saline (often considered as placebo) and lasts for 2-4 weeks on ...
What is the optimum frequency for corticosteroid injections . ...A consensus guideline from the American College of Rheumatology states that ICS injections should be given no more than every 3 months per joint for a maximum ...
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