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

Trial Summary

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 data supports the effectiveness of the drug methylprednisolone acetate for treating frozen shoulder?

Research shows that injections of methylprednisolone acetate 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 the combination of physical therapy and steroids safe for treating frozen shoulder?

Methylprednisolone acetate, a type of steroid, is generally safe when used correctly, but accidental injections into the eye can cause serious damage. For shoulder treatments, it has been used safely to relieve pain and improve movement, though it should be administered carefully to avoid complications. ^{2 3 4 6 7}

How does the treatment of Depot Methylprednisolone and Physical Therapy for frozen shoulder differ from other treatments?

This treatment combines Depot Methylprednisolone, a steroid injection that reduces inflammation and pain, with physical therapy to improve shoulder movement, offering a dual approach that targets both pain relief and mobility, unlike treatments that use only one method. ^{2 3 4 5 8}

What is the purpose of this trial?

This trial compares two treatments for frozen shoulder: one with physical therapy and steroid injections, and the other with just steroid injections followed by observation. It aims to see if physical therapy offers extra benefits and if the cost is justified. The study focuses on adults with frozen shoulder to find the most effective and economical treatment.

Research Team

Scott D. Martin, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

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

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

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

Management of painful shoulder. [2019]

3. England pubmed.ncbi.nlm.nih.gov

High-dose short-course oral corticosteroid protocol for treatment of primary frozen shoulder: a retrospective cohort 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. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Survey of orthopaedic and sports medicine physicians regarding use of medrol dosepak for sports injuries. [2018]

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

Retinal necrosis secondary to inadvertent intravitreal methylprednisolone acetate (depo-medrol) injection during pars plana vitrectomy. [2014]

8. England pubmed.ncbi.nlm.nih.gov

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