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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of two different injections in relieving shoulder pain caused by osteoarthritis, a condition where the shoulder joint deteriorates. One group receives an intra-articular corticosteroid injection (also known as a steroid or cortisone injection), while the other receives an intra-articular platelet-rich plasma (PRP) injection. The researchers aim to determine which treatment offers better relief and potentially delays the need for shoulder surgery. Individuals diagnosed with primary shoulder osteoarthritis and experiencing significant pain may be suitable candidates for this study. As an unphased trial, this study provides an opportunity to explore innovative treatments that could enhance quality of life.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Past studies have shown that injections of corticosteroids directly into the joint have a low complication rate, ranging from 1% to 15%. The most common issue is temporary pain after the injection, with most people returning to normal within two to three months.

Research indicates that platelet-rich plasma (PRP) injections are generally safe. PRP uses components of the patient's own blood to aid healing and has shown promise for various conditions. Safety data for PRP is positive, with no major safety concerns reported.

Both treatments are widely used and considered safe based on current research. Prospective trial participants should know that these treatments have been studied and found to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for shoulder osteoarthritis because they offer innovative approaches beyond the typical oral medications and physical therapy options. Intra-articular corticosteroid injections, like Depo-Medrol, aim to deliver targeted relief directly into the joint, potentially reducing inflammation and pain more efficiently. Meanwhile, platelet-rich plasma (PRP) injections use the patient’s own blood components to promote healing and tissue regeneration, offering a natural alternative to traditional treatments. Both methods utilize ultrasound guidance for precise delivery, which could enhance effectiveness and minimize side effects compared to broader systemic therapies.

What evidence suggests that this trial's treatments could be effective for shoulder osteoarthritis?

This trial will compare the effects of two different intra-articular injections for shoulder osteoarthritis. Participants in the Corticosteroid Injection Group will receive corticosteroid injections directly into the shoulder joint. Studies have shown that these injections can provide short-term relief for shoulder arthritis, with effects lasting about 2 to 4 weeks. Research indicates that they can help reduce pain and improve shoulder movement, though the benefits are often modest. Meanwhile, participants in the Platelet-Rich Plasma Injection Group will receive PRP injections. Studies suggest that PRP injections might offer better pain relief and improved shoulder function compared to other treatments, including corticosteroids. PRP has shown better results for shoulder problems, with improvements noticeable as early as 8 weeks after treatment. Both treatments aim to reduce pain and improve daily life for those with shoulder arthritis, but PRP might be slightly more effective in the long run. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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 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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10836165/

Debate: Intra-articular steroid injections for osteoarthritis Systematic reviews show that the treatment effect is modest compared with intra-articular saline (often considered as placebo) and lasts for 2–4 weeks on ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2665913124000517

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, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9163723/

Clinical Fate of Glenohumeral Osteoarthritis Following ... The purpose of this study was to investigate the clinical fate of symptomatic glenohumeral OA following intraarticular corticosteroid injection.

4. academic.oup.com academic.oup.com/rheumatology/article/64/6/3832/8046668

Effect of intra-articular corticosteroid injections for ... To estimate the effect of intra-articular corticosteroid injection (IACI) for osteoarthritis on longer-term incidence of pain medications.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03586687

NCT03586687 | Osteoarthritis Shoulder Injection Study The purpose of this study is to determine the most effective intraarticular steroid dose for the treatment of glenohumeral osteoarthritis.

6. rapm.bmj.com rapm.bmj.com/content/early/2025/03/11/rapm-2024-105656

Use and safety of corticosteroid injections in joints and ... Results vary by musculoskeletal region, but most studies report short-term benefit with mixed results on long-term relief. Publications showed ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3658381/

Glenohumeral Joint Injections: A Review - PMC The complication rate of intra-articular corticosteroid injections is relatively low (1%-15%). One of the most common complications is transient pain during ...