200 Participants Needed

Intra-articular Injections for Shoulder Osteoarthritis

(GHOA Trial)

CM
AY
Overseen ByAdam Yanke, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rush University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Intra-articular Injections for Shoulder Osteoarthritis?

Research shows that platelet-rich plasma (PRP) injections can reduce pain and improve joint function in knee osteoarthritis, and have beneficial effects in managing joint degenerative conditions. Additionally, corticosteroid injections are used to treat shoulder pain, suggesting potential benefits for shoulder osteoarthritis.12345

Is it safe to use intra-articular injections for shoulder osteoarthritis?

Research has shown that intra-articular platelet-rich plasma (PRP) injections are safe for use in humans, as confirmed in studies with patients having knee osteoarthritis. Corticosteroid injections are also commonly used and considered safe for treating shoulder pain.12467

How does the treatment of intra-articular injections for shoulder osteoarthritis differ from other treatments?

Intra-articular injections for shoulder osteoarthritis, such as corticosteroid and platelet-rich plasma (PRP) injections, are unique because they are directly administered into the joint, providing targeted relief. PRP injections are particularly novel as they use components from the patient's own blood to promote healing and reduce inflammation, offering a natural alternative to traditional steroid injections.12389

What is the purpose of this trial?

The purpose of this study is to compare the efficacy of intra-articular corticosteroid injections versus platelet-rich plasma injections for non-operative treatment of primary glenohumeral osteoarthritis. The efficacy of intra-articular injections, outside of hyaluronic acid, for the treatment of glenohumeral OA is not known, yet these treatments are commonly used with hopes of providing patients with symptomatic relief that can hopefully delay or prevent the need for shoulder arthroplasty. This study will help elucidate the therapeutic benefit of corticosteroid and Platelet Rich Plasma (PRP) injections in this patient population.

Eligibility Criteria

This trial is for adults over 18 with primary glenohumeral osteoarthritis, which means they have significant shoulder joint pain and damage seen on X-rays. They must be experiencing a baseline pain level of more than moderate intensity. People who've had recent shoulder surgery, are pregnant, involved in workers' compensation cases for the shoulder, or have other types of arthritis or allergies to lidocaine can't participate.

Inclusion Criteria

My pain level is more than 4 on a scale of 0-10.
I have been diagnosed with shoulder arthritis through X-rays and doctor's exams.

Exclusion Criteria

Known pregnancy
I haven't had a shoulder joint injection in the last 3 months.
My arthritis is not caused by infections, injuries, or other specific conditions.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either corticosteroid or platelet-rich plasma injections for the treatment of primary glenohumeral osteoarthritis

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Intra-articular Corticosteroid Injection
  • Intra-articular Platelet-rich Plasma Injection
Trial Overview The study aims to see if corticosteroid injections into the shoulder joint work better than platelet-rich plasma (PRP) injections for treating primary glenohumeral osteoarthritis without surgery. It's testing whether these treatments can relieve symptoms enough to delay or avoid shoulder replacement surgery.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Corticosteroid Injection GroupExperimental Treatment1 Intervention
80mg Depo-Medrol and 8cc Lidocaine ultrasound-guided intra-articular injection
Group II: Platelet-Rich Plasma Injection GroupActive Control1 Intervention
15cc blood draw in Arthrex Autologous Conditioned Plasma (ACP) kit and processed per manufacturer instructions Ultrasound-guided intra-articular injection of isolated PRP

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

🇺🇸
Approved in United States as Corticosteroid Injection for:
  • Osteoarthritis
  • Shoulder arthritis
  • Glenohumeral osteoarthritis
  • Rotator cuff disease
  • Adhesive capsulitis
  • Acromioclavicular joint disease
🇪🇺
Approved in European Union as Corticosteroid Injection for:
  • Osteoarthritis
  • Shoulder arthritis
  • Glenohumeral osteoarthritis
  • Rotator cuff disease
  • Adhesive capsulitis
  • Acromioclavicular joint disease
🇨🇦
Approved in Canada as Corticosteroid Injection for:
  • Osteoarthritis
  • Shoulder arthritis
  • Glenohumeral osteoarthritis
  • Rotator cuff disease
  • Adhesive capsulitis
  • Acromioclavicular joint disease

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials
448
Recruited
247,000+

Findings from Research

In a study involving 60 patients with adhesive capsulitis of the shoulder, a single intra-articular injection of platelet-rich plasma (PRP) was found to be more effective than corticosteroid (CS) injections in reducing pain and improving shoulder function over a 12-week period.
Patients receiving PRP showed greater improvements in pain scores and range of motion compared to those receiving corticosteroids, with no major complications reported, indicating that PRP may be a safer and more effective treatment option for this condition.
Single Intra-articular Platelet-Rich Plasma Versus Corticosteroid Injections in the Treatment of Adhesive Capsulitis of the Shoulder: A Cohort Study.Barman, A., Mukherjee, S., Sahoo, J., et al.[2020]
In a study involving 54 patients with knee osteoarthritis, adding growth hormone (Somatropin) to platelet rich plasma (PRP) injections significantly improved joint function in the first month compared to PRP alone, as measured by the WOMAC score.
Both treatment groups experienced a significant reduction in WOMAC scores after injections, and no complications were reported, indicating that the combined treatment is safe and effective for improving knee function.
Adding Intra-Articular Growth Hormone to Platelet Rich Plasma under Ultrasound Guidance in Knee Osteoarthritis: A Comparative Double-Blind Clinical Trial.Rahimzadeh, P., Imani, F., Faiz, SH., et al.[2022]
Platelet-rich plasma (PRP) therapy is a cost-effective and minimally invasive treatment option for patients with joint degenerative conditions, particularly osteoarthritis.
PRP injections provide nourishment to cartilage cells (chondrocytes) through a rich supply of growth factors and cytokines, leading to promising outcomes in managing osteoarthritis symptoms.
Role of Intra-articular Platelet Rich Plasma in the Management of Osteoarthritis: A Review.Zubair, U., Salam, O., Zubair, Z.[2020]

References

Single Intra-articular Platelet-Rich Plasma Versus Corticosteroid Injections in the Treatment of Adhesive Capsulitis of the Shoulder: A Cohort Study. [2020]
Adding Intra-Articular Growth Hormone to Platelet Rich Plasma under Ultrasound Guidance in Knee Osteoarthritis: A Comparative Double-Blind Clinical Trial. [2022]
Role of Intra-articular Platelet Rich Plasma in the Management of Osteoarthritis: A Review. [2020]
Effects of corticosteroids and platelet-rich plasma on synoviocytes in IL-1ß-induced inflammatory condition. [2022]
Injection of platelet-rich plasma in patients with primary and secondary knee osteoarthritis: a pilot study. [2022]
Intra-Articular Leukocyte-Poor Platelet-Rich Plasma Injections for Japanese Patients With Osteoarthritis of the Knee: A Three-Year Observational Retrospective Study After Phase 1 and Phase 2a Trials. [2022]
Comparison of the Efficacy of Platelet-Rich Plasma (PRP) and Local Corticosteroid Injection in Periarthritis Shoulder: A Prospective, Randomized, Open, Blinded End-Point (PROBE) Study. [2022]
[Effectiveness of platelet rich plasma in pain management of osteoarthritis knee: double blind, randomized comparative study]. [2022]
Clinical Fate of Glenohumeral Osteoarthritis Following Intraarticular Corticosteroid Injection: An Analysis in 311 Shoulders. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security