Physical Therapy and Steroids for Frozen Shoulder

Overseen By Scott D Martin, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Massachusetts General Hospital

Disqualifiers: Non-English, Pregnant, Prior surgery, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-12 months

260 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatment approaches for frozen shoulder, a condition that causes pain and limits shoulder movement. One group will receive regular physical therapy with steroid injections, while the other group will receive only the injections and be monitored over time. The study aims to determine if physical therapy significantly improves recovery compared to steroid shots alone. Individuals diagnosed with frozen shoulder who experience shoulder pain and stiffness might be a good fit for this trial. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, helping researchers understand its benefits for more patients.

Will I have to stop taking my current medications?

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

What is the safety track record for these treatments?

Research has shown that depot methylprednisolone is generally safe when used correctly for conditions like frozen shoulder. Studies have found that this steroid can provide short-term pain relief. However, injecting it into the eye by mistake can cause serious harm, though this risk does not apply to shoulder treatments.

Research indicates that physical therapy is a safe and effective way to treat frozen shoulder. It helps reduce pain and improve shoulder movement. Most patients respond well, with many experiencing significant recovery.

In both treatments, serious side effects are rare. Patients usually tolerate the combination of steroids and physical therapy well. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for frozen shoulder because they combine the power of physical therapy with a targeted steroid injection, which is not typical in current standard care. Most treatments for frozen shoulder primarily involve physical therapy or steroid injections separately. The unique aspect here is the combination approach: one group is getting physical therapy alongside a steroid injection, potentially enhancing recovery by reducing inflammation quickly while improving shoulder mobility. The other group is solely receiving a steroid injection, offering a less invasive alternative to more aggressive treatments. This dual approach could offer faster relief and improved outcomes for patients in the inflammatory phase of frozen shoulder.

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

Research shows that injections of methylprednisolone can greatly reduce pain and improve shoulder movement in people with frozen shoulder. Studies support that these steroid injections work well for short-term pain relief. In this trial, one group of participants will receive physical therapy combined with steroid injections to help improve movement and reduce pain over time. Another group will receive only steroid injections, without additional therapeutic intervention. Some studies suggest that physical therapy alone might not be as effective as other treatments, but it can still be helpful when combined with steroid injections. Overall, both treatments have shown promise in effectively managing frozen shoulder symptoms. ^{2 3 4 6 7}

Who Is on the Research Team?

Scott D. Martin, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

Adults over 18 with adhesive capsulitis, also known as frozen shoulder, can join this study. They must understand English and be open to being randomly placed in one of two treatment groups. Pregnant women or those who've had surgery for this condition before cannot participate.

Inclusion Criteria

I am willing to be assigned to any treatment group by chance.

I have been diagnosed with frozen shoulder.

Exclusion Criteria

I have had surgery for my condition before.

Pregnant women (women of childbearing potential will be advised to undergo regular pregnancy testing)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into two arms: one receiving regular physical therapy with corticosteroid injections, and the other receiving steroid injections followed by watchful waiting.

6-12 months

Follow-up

Participants are monitored for functional outcomes using DASH, ASES, and Constant shoulder score sheets at 1 year post-enrollment.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Depot Methylprednisolone
• Physical Therapy

Trial Overview

The trial is testing if physical therapy combined with steroid injections offers better outcomes than just steroid injections followed by observation for treating frozen shoulder. Participants will either receive regular physical therapy and steroids (Arm 1) or only steroids during the inflammation phase plus monitoring (Arm 2).

How Is the Trial Designed?

Group I: Watchful Waiting with Steroid Injection Experimental Treatment 1 Intervention

Patients will undergo no therapeutic intervention outside of steroid injection. If they are in the inflammatory phase of the condition, they will receive 40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine.

Group II: Physical Therapy with Steroid Injection Experimental Treatment 2 Interventions

Patients will undergo regular physical therapy as defined by the standard of care at Massachusetts General Hospital for Adhesive Capsulitis (Frozen Shoulder). If they are in the inflammatory phase of the condition, they will receive 40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine.

Depot Methylprednisolone is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Depo-Medrol for:

• Adhesive capsulitis
• Osteoarthritis
• Rheumatoid arthritis
• Bursitis
• Tendinitis

Approved in European Union as Depo-Medrol for:

• Adhesive capsulitis
• Osteoarthritis
• Rheumatoid arthritis
• Bursitis
• Tendinitis

Approved in Canada as Depo-Medrol for:

• Adhesive capsulitis
• Osteoarthritis
• Rheumatoid arthritis
• Bursitis
• Tendinitis

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

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]

Inadvertent injection of methylprednisolone acetate into the eye during vitrectomy can lead to severe retinal toxicity, resulting in significant vision loss and complications such as retinal necrosis and optic nerve damage.

This case highlights the critical need for careful identification of medications during eye surgeries to prevent serious adverse effects associated with incorrect injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retinal necrosis secondary to inadvertent intravitreal methylprednisolone acetate (depo-medrol) injection during pars plana vitrectomy. Yonekawa, Y., Sun, G., D'Amico, DJ., et al.[2014]

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 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]

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 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 survey of sports medicine physicians revealed that 47% prescribe methylprednisolone taper (Medrol Dosepak) for sports injuries, particularly in patients aged 40 and younger, with postinjury disease being the most common reason for its use.

Concerns about complications, especially the risk of osteonecrosis (reported in 8.5% of prescribers), and a lack of proven efficacy were significant reasons for the 52% of physicians who chose not to prescribe Medrol Dosepak.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of orthopaedic and sports medicine physicians regarding use of medrol dosepak for sports injuries. Langer, P., Fadale, P., Hulstyn, M., et al.[2018]

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]

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