Methylprednisolone for Frozen Shoulder

Overseen By Nimish Mittal

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University Health Network, Toronto

Must not be taking: Blood thinners, Antibiotics

Disqualifiers: Recent shoulder injection, Surgery, Osteoarthritis, Pregnancy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of two different doses of methylprednisolone (a corticosteroid) for treating frozen shoulder, a condition that causes stiffness and pain. Researchers aim to determine if a lower dose (40 mg) is as effective as a higher dose (80 mg) when combined with hydrodilatation, a procedure that involves injecting fluid into the shoulder to improve movement. Participants will be randomly assigned to receive one of the two doses, and neither they nor the doctors will know which dose is administered. Individuals with frozen shoulder who have not had recent shoulder injections are suitable candidates for this study. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to the development of a new treatment option.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on blood thinners (except low-dose Aspirin) or have an active infection requiring antibiotics.

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

Research shows that corticosteroid injections, such as methylprednisolone, are generally safe and effective for treating frozen shoulder. These injections can quickly relieve pain and improve movement for several weeks. A common dose of 40 mg is often used because patients tolerate it well, and it provides short-term relief, typically lasting up to 12 weeks.

Other studies suggest that injections directly into the joint are safe for frozen shoulder and can have positive effects lasting up to 24–36 weeks. While this treatment is usually well-tolerated, monitoring for any side effects, which are usually mild, is important.

In this specific study, researchers are comparing two doses, 40 mg and 80 mg, to determine which is better at reducing pain and improving shoulder movement. The research will help establish if the higher dose offers any extra benefits or more side effects. Overall, corticosteroid injections have a strong safety record, making them a reliable option for many patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for frozen shoulder?

Methylprednisolone is unique because it targets inflammation more directly compared to many standard treatments for frozen shoulder, like physical therapy and non-steroidal anti-inflammatory drugs (NSAIDs). This corticosteroid is administered as an injection, which can deliver the medicine right to the source of pain and stiffness, potentially providing faster relief. Researchers are excited about this treatment because it might offer quicker improvements in shoulder mobility and pain reduction, which could significantly enhance daily functioning for patients.

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

Research shows that methylprednisolone can help treat frozen shoulder, a condition where the shoulder becomes stiff and painful. One study found that steroid injections like methylprednisolone improved pain relief and shoulder movement over time. Another study showed that injecting corticosteroids, including methylprednisolone, directly into the joint is one of the most effective treatments for this condition. This trial will compare different doses of methylprednisolone, with participants receiving either a 40 mg dose or an 80 mg dose. Research comparing different doses found significant improvements in pain and disability, especially with higher doses. This suggests that methylprednisolone, whether at 40 mg or 80 mg, may help reduce shoulder pain and improve movement. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with adhesive capsulitis, also known as frozen shoulder. Participants will be treated at the Toronto Rehabilitation Institute and must be available for follow-ups over a year. Specific eligibility criteria are not provided, but typically include having the condition without other complicating factors.

Inclusion Criteria

I have been diagnosed with frozen shoulder.

I am older than 18 years.

Exclusion Criteria

I have had surgery on my affected shoulder before.

I am currently on antibiotics for an infection.

I have not had an injection in my affected shoulder in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an ultrasound-guided shoulder hydrodilatation combined with corticosteroid, randomized to either 40 mg or 80 mg of methylprednisolone

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain reduction, shoulder mobility, and side effects with assessments at baseline, 4 weeks, and 3 months after the procedure

3 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Methylprednisolone

Trial Overview The study is testing two doses of Methylprednisolone (40 mg vs 80 mg) combined with hydrodilatation to see which is more effective in reducing pain and improving shoulder mobility in patients with frozen shoulder. It's a double-blind study, meaning neither doctors nor patients know who gets which dose.

How Is the Trial Designed?

Group I: Group A Active Control 1 Intervention

40mg methylprednisolone dose

Group II: Group B Active Control 1 Intervention

80mg methylprednisolone dose

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

High-dose oral prednisolone (1 mg/kg/day) significantly improves shoulder motion and reduces pain in patients with early-stage primary frozen shoulder, with noticeable effects within 4 weeks and lasting improvements at 6 months.

While rapid recovery of shoulder motion and pain relief are observed early, functional outcomes measured by DASH and ASES scores show more gradual improvement, highlighting the need for longer-term assessment of treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose short-course oral corticosteroid protocol for treatment of primary frozen shoulder: a retrospective cohort study. Atici, T., Ermutlu, C., Akesen, S., et al.[2021]

In a study of 135 patients with frozen shoulder, both triamcinolone acetonide and methylprednisolone acetate were found to be equally effective for primary frozen shoulder, with success rates of 81.8% and 83.3%, respectively.

Triamcinolone acetonide was particularly effective for diabetic frozen shoulder, showing a significant improvement rate of 69% compared to 39% for methylprednisolone acetate, and required fewer injections for similar or better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between intraarticular triamcinolone acetonide and methylprednisolone acetate injections in treatment of frozen shoulder. Sakeni, RA., Al-Nimer, MS.[2018]

In a study of 100 patients with frozen shoulder, those who received manipulation under anaesthesia (MUA) combined with an intra-articular normal saline injection showed better outcomes compared to those who had MUA alone or with a steroid injection.

The treatment was found to be safe and effective, particularly highlighting the high failure rate among diabetic patients, suggesting that the combination of MUA and saline injection could be a cost-effective option for managing frozen shoulder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manipulation under anaesthesia for the treatment of frozen shoulder. Hamdan, TA., Al-Essa, KA.[2015]

In a study of 42 patients with frozen shoulder followed for eight months, steroid injections provided early benefits in pain relief and improved range of motion compared to other treatments.

Overall, there was little long-term advantage observed from any of the treatment regimens, including mobilizations, ice therapy, or no treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frozen shoulder: prospective clinical study with an evaluation of three treatment regimens. Bulgen, DY., Binder, AI., Hazleman, BL., et al.[2022]

A study involving 52 patients with idiopathic frozen shoulder found that combining physiotherapy with intra-articular methylprednisolone injection significantly improved shoulder mobility and reduced pain compared to physiotherapy alone, with notable results at 6 weeks and 3 months.

The combination treatment not only enhanced the range of motion (flexion, abduction, and external rotation) but also led to better scores in the Shoulder Pain and Disability Index, indicating a more effective approach for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Outcome of Two Different Regimes in Adhesive Capsulitis: A Prospective Clinical Study. Anjum, R., Aggarwal, J., Gautam, R., et al.[2021]

In a study of 40 patients with frozen shoulder, those treated with oral prednisolone experienced a faster improvement in nighttime pain compared to the nontreatment group, indicating some efficacy of the medication in managing specific symptoms.

Despite the initial improvement in nighttime pain, there was no significant difference in overall pain levels or range of movement between the two groups after 8 months, suggesting that while prednisolone may help with certain symptoms, it does not lead to complete recovery from the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled study of oral prednisolone in frozen shoulder. Binder, A., Hazleman, BL., Parr, G., et al.[2019]

In a study of 55 patients with painful shoulders, 80% experienced complete pain relief within two weeks of receiving multiple injections of methylprednisolone acetate, and 95% were pain-free by four weeks.

After eight weeks of treatment, 90% of patients achieved significant functional recovery, indicating that early intervention for painful shoulders is crucial to prevent progression to 'frozen shoulder' and preserve normal movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of painful shoulder. Roy, S., Oldham, R.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7315175/

Evaluating the Outcome of Two Different Regimes in ... The Shoulder Pain and Disability Index showed improvement in both pain and disability score in group B compared to group A, and improvement was significant at 6 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1058274623001234

Oral corticosteroids vs. exercises on treatment of frozen ... Planned pairwise comparisons demonstrated significant improvements in pain relief and functional outcomes in both groups at the 6- and 12-week follow-ups ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2774247

Comparison of Treatments for Frozen Shoulder IA corticosteroid had the highest probability (85%) of being the second most effective. Physiotherapy was the least effective treatment, ...

4. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/143295-need-for-intra-articular-corticosteroid-injections-in-patients-with-frozen-shoulder

Need for intra-articular corticosteroid injections in patients ... The prevalence of frozen shoulder in patients with DM is estimated to be over 20%, compared with 2–5% in the general population.

5. painphysicianjournal.com painphysicianjournal.com/current/pdf?article=NzcxNA%3D%3D&journal=154

versus Low-dose Steroid Injection for Adhesive Capsulitis ( ... This systematic review and meta-analysis compared the efficacy of different dosages of steroid injections in patients with frozen shoulder. Our results showed ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5165171/

Corticosteroid injection for adhesive capsulitis in primary care Results revealed that corticosteroid injection is superior to placebo and physiotherapy in the short-term (up to 12 weeks). There was no difference in outcomes ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06229964

Frozen Shoulder Treatment with Intra-Articular ... Evidence suggests that 20mg of triamcinolone or methylprednisolone maybe as effective in frozen shoulder than 40mg but the dosage of 40mg remains most common ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0929664625004449

Comparing non-surgical treatment strategies for adhesive ... In summary, IA corticosteroid injections are associated with more rapid initial improvements in pain and functional recovery compared to SA ...

9. emedicine.medscape.com emedicine.medscape.com/article/1261598-treatment

Adhesive Capsulitis (Frozen Shoulder) Treatment & ... Corticosteroid injections provide rapid relief that typically lasts for 6 weeks. Long-term outcomes are similar to those with placebo. A ...