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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find out if the treatment of adhesive capsulitis with 40 mg of methylprednisolone in combination with a hydrodilatation is comparable to 80 mg of methylprednisolone for pain reduction, improving shoulder mobility, and reducing side effects. Researchers will enroll 40 people in this study which is taking place solely at the Toronto Rehabilitation Institute, University Avenue. This study should take approximately 12 months to complete and the results should be known in about 15 to 18 months. During this study, patients will receive an ultrasound guided shoulder hydrodilatation combined with corticosteroid after "randomized" into one of the groups (40 mg vs 80 mg). This is a double blind study as both patients and physicians would not know the group patient was randomized to. Pain scores, Range of Motion and few other questionnaires wold be completed to track the response to the interventions at baseline prior to injection, four weeks after the procedure and 3 months after the procedure.

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.

What data supports the effectiveness of the drug Methylprednisolone for treating frozen shoulder?

Research shows that injections of methylprednisolone can significantly reduce pain and improve shoulder movement in patients with frozen shoulder, with 95% of patients becoming pain-free within four weeks and achieving maximum functional recovery in eight weeks. ^{1 2 3 4 5}

Is methylprednisolone safe for treating frozen shoulder?

The studies reviewed do not provide specific safety data for methylprednisolone in treating frozen shoulder, but it is commonly used in medical practice, suggesting it is generally considered safe when used appropriately. ^{1 2 3 4 6}

How does the drug methylprednisolone differ from other treatments for frozen shoulder?

Methylprednisolone is a corticosteroid that can be injected directly into the shoulder joint to reduce inflammation and pain, leading to improved movement. This approach is different from other treatments like physiotherapy alone or manipulation under anesthesia, as it directly targets inflammation within the joint. ^{1 2 3 4 7}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

High-dose short-course oral corticosteroid protocol for treatment of primary frozen shoulder: a retrospective cohort study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Management of painful shoulder. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluating the Outcome of Two Different Regimes in Adhesive Capsulitis: A Prospective Clinical Study. [2021]

4. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Comparison between intraarticular triamcinolone acetonide and methylprednisolone acetate injections in treatment of frozen shoulder. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Frozen shoulder: prospective clinical study with an evaluation of three treatment regimens. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A controlled study of oral prednisolone in frozen shoulder. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Manipulation under anaesthesia for the treatment of frozen shoulder. [2015]