Intra-articular Injections for Shoulder Osteoarthritis

(GHOA Trial)

Overseen By Adam Yanke, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Rheumatoid arthritis, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

200 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 4 6 7}

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. ^{1 2 3 8 9}

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.

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

Group I: Corticosteroid Injection Group Experimental Treatment 1 Intervention

80mg Depo-Medrol and 8cc Lidocaine ultrasound-guided intra-articular injection

Group II: Platelet-Rich Plasma Injection Group Active Control 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Intra-articular Platelet Rich Plasma in the Management of Osteoarthritis: A Review. Zubair, U., Salam, O., Zubair, Z.[2020]

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]

In a preliminary study of 14 patients with knee osteoarthritis, intraarticular platelet-rich plasma (PRP) injections showed significant improvements in pain and function, with no reported adverse events, indicating a favorable safety profile.

Patients experienced almost linear improvements in their Knee Injury and Osteoarthritis Outcome Scores over 12 months, suggesting that PRP may effectively relieve symptoms of osteoarthritis and warrant further investigation in larger clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injection of platelet-rich plasma in patients with primary and secondary knee osteoarthritis: a pilot study. Sampson, S., Reed, M., Silvers, H., et al.[2022]

In a study of nine women with knee osteoarthritis, intra-articular injections of leukocyte-poor platelet-rich plasma (LP-PRP) led to significant improvements in functional knee scores over a three-year follow-up, particularly in gait and stair navigation.

Most patients (six out of eight) did not require additional treatment, and while some radiological progression was noted, the overall safety and feasibility of LP-PRP injections were confirmed, with no worsening of osteoarthritis in the majority of participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Taniguchi, Y., Yoshioka, T., Sugaya, H., et al.[2022]

In a study of 60 patients with frozen shoulder, platelet-rich plasma (PRP) injections significantly reduced pain and disability over the long term compared to triamcinolone, with VAS scores of 14.33 for PRP versus 31.63 for triamcinolone after 24 weeks.

While triamcinolone provided better short-term relief, PRP demonstrated superior long-term efficacy in improving shoulder function, as indicated by DASH scores of 18.08 for PRP compared to 31.76 for triamcinolone after the same period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Gupta, GK., Shekhar, S., Haque, ZU., et al.[2022]

Intra-articular injections of platelet-rich plasma (PRP) significantly reduced pain and stiffness in patients with bilateral knee osteoarthritis, with VAS scores improving from 8.4 to 4.85 after 6 months (p < 0.001).

Compared to normal saline, PRP injections also led to notable improvements in physical function and joint stiffness, demonstrating its efficacy as a treatment for knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of platelet rich plasma in pain management of osteoarthritis knee: double blind, randomized comparative study]. Ghai, B., Gupta, V., Jain, A., et al.[2022]

In a study of 311 shoulders from 275 patients with glenohumeral osteoarthritis, about 37.3% underwent shoulder arthroplasty within 3 to 8 years after receiving intraarticular corticosteroid injections, indicating that while these injections can provide temporary relief, many patients may still require surgery.

Factors such as high-grade radiographic arthritis, being female, younger age, and nonsmoking status were significantly associated with a higher likelihood of needing shoulder arthroplasty, which can help guide patient counseling regarding their treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Fate of Glenohumeral Osteoarthritis Following Intraarticular Corticosteroid Injection: An Analysis in 311 Shoulders. Kim, HM., Muhammad, M., Heil, SD., et al.[2022]

References

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

Single Intra-articular Platelet-Rich Plasma Versus Corticosteroid Injections in the Treatment of Adhesive Capsulitis of the Shoulder: A Cohort Study. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Adding Intra-Articular Growth Hormone to Platelet Rich Plasma under Ultrasound Guidance in Knee Osteoarthritis: A Comparative Double-Blind Clinical Trial. [2022]

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

Role of Intra-articular Platelet Rich Plasma in the Management of Osteoarthritis: A Review. [2020]

4. England pubmed.ncbi.nlm.nih.gov

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

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

Injection of platelet-rich plasma in patients with primary and secondary knee osteoarthritis: a pilot study. [2022]

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

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]

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

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]

8. Brazil pubmed.ncbi.nlm.nih.gov

[Effectiveness of platelet rich plasma in pain management of osteoarthritis knee: double blind, randomized comparative study]. [2022]

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

Clinical Fate of Glenohumeral Osteoarthritis Following Intraarticular Corticosteroid Injection: An Analysis in 311 Shoulders. [2022]