ERMI Shoulder Flexionater® for Frozen Shoulder

Overseen By Viki Sochor

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Foundation for Orthopaedic Research and Education

Must be taking: Cortisone

Disqualifiers: Rheumatoid arthritis, Infection, Osteoarthritis, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

210 Participants Needed

Trial Summary

What is the purpose of this trial?

Study 1 - Adhesive Capsulitis Study - 110 patients The purpose of this study is to compare treatment of patients with symptoms of adhesive capsulitis, primary and secondary, between three groups: I) Physical Therapy alone; II) ERMI Shoulder Flexionater® alone; III) PT + Device. Study 2 - Postoperative Shoulder Stiffness Study - 90 patients The purpose of this study is to compare treatment of patients with post-operative stiffness indicative of secondary adhesive capsulitis between three groups: I) Physical Therapy alone; II) ERMI Shoulder Flexionater® alone; III) PT + Device. Study 3 - Stiffness after MUA Study - enroll all eligible patients (goal of at least 15) The purpose of this study is to compare treatment of patients who have undergone manipulation under anesthesia or lysis of adhesions between three groups: I) Physical Therapy alone; II) ERMI Shoulder Flexionater® alone; III) PT + Device.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, all patients in Study Group 1 will receive a cortisone shot, which may interact with certain medications. It's best to discuss your current medications with the trial coordinators.

What data supports the effectiveness of the ERMI Shoulder Flexionater treatment for frozen shoulder?

The research suggests that treatments involving mobilization techniques, like the end-range mobilization/scapular mobilization approach, can improve shoulder movement and reduce disability in people with frozen shoulder. This implies that similar mobilization treatments, such as the ERMI Shoulder Flexionater, might also be effective. ^{1 2 3 4 5}

How does the ERMI Shoulder Flexionater® treatment differ from other treatments for frozen shoulder?

The ERMI Shoulder Flexionater® is unique because it likely involves a specific mechanical device designed to improve shoulder mobility, which may offer a more controlled and targeted approach compared to traditional physical therapy or mobilization techniques. This could potentially reduce pain and improve range of motion more effectively by focusing on precise movements and adjustments. ^{1 6 7 8 9}

Research Team

Peter Simon, PhD

Principal Investigator

Foundation for Orthopaedic Research and Education

Eligibility Criteria

This trial is for patients with shoulder pain and limited motion due to bursitis or frozen shoulder, specifically those not recovering normally after certain surgeries. Eligible participants include those with less than normal range of motion at specific post-op checkpoints, who have had a cortisone shot, or underwent procedures like manipulation under anesthesia. People with prior shoulder surgery, infections, rheumatoid arthritis, or other conditions causing pain/limited movement are excluded.

Inclusion Criteria

I have shoulder pain and limited movement for over a month and have received a cortisone shot.

My recovery after surgery is slower than expected.

I have had surgery to remove internal scar tissue.

Exclusion Criteria

I need surgery again due to an infection or I have rheumatoid arthritis.

I have conditions like arthritis or shoulder issues that could cause pain or limit movement.

You have not had shoulder surgery, an infection, or any conditions that could cause pain or limit your range of motion in your shoulder. This includes conditions like inflammatory joint disease, osteoarthritis, and a history of major shoulder injury or surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated with either Physical Therapy alone, ERMI Shoulder Flexionater® alone, or a combination of both

3 months

Regular visits as per treatment protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Periodic follow-up visits

Treatment Details

Interventions

• ERMI Shoulder Flexionater

Trial Overview The study tests the effectiveness of the ERMI Shoulder Flexionater®, a high-intensity stretch device. It's compared across three groups: one receiving only physical therapy (PT), another using just the device, and a third combining PT with the device. The goal is to see which method best improves shoulder flexibility in different scenarios including post-surgery stiffness and stiffness after manipulation under anesthesia.

Participant Groups

Group I: Adhesive Capsulitis Study Active Control 1 Intervention

The purpose of this study is to compare treatment efficacy of patients with symptoms of primary and secondary adhesive capsulitis between three groups: 1) Patients treated with Physical Therapy alone; 2) Patients treated with the ERMI Shoulder Flexionater® alone; 3) Patients treated with PT + Device in the treatment.

Group II: Post operative Shoulder Stiffness Study Active Control 1 Intervention

The purpose of this study is to compare treatment efficacy of patients with post-operative stiffness indicative of secondary adhesive capsulitis between three groups: I) Patients treated with Physical Therapy alone; II) Patients treated with the ERMI Shoulder Flexionater® alone; III) Patients treated with PT + Device in the treatment.

Group III: Secondary Surgery Study Active Control 1 Intervention

The purpose of this study is to compare recovery of patients who have undergone a manipulation under anesthesia or a lysis of adhesions between three groups: 1) Patients treated with Physical Therapy alone; 2) Patients treated with the ERMI Shoulder Flexionater® alone; 3) Patients treated with PT + Device in the treatment.

Who Is Running the Clinical Trial?

Foundation for Orthopaedic Research and Education

Lead Sponsor

Trials

16

Recruited

1,000+

ERMI, LLC

Collaborator

Trials

1

Recruited

210+

Findings from Research

The end-range mobilization/scapular mobilization treatment approach (EMSMTA) significantly improved shoulder range of motion and reduced disability in patients with frozen shoulder syndrome compared to a standardized physical therapy program, with notable improvements observed at both 4 and 8 weeks.

In a study of 34 subjects, those receiving EMSMTA showed greater enhancements in shoulder kinematics and function, indicating that this targeted treatment may be more effective for specific patients with abnormal shoulder movement patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the end-range mobilization and scapular mobilization approach in a subgroup of subjects with frozen shoulder syndrome: a randomized control trial. Yang, JL., Jan, MH., Chang, CW., et al.[2022]

In a study of 43 patients with chronic frozen shoulder, the main issue identified was the contracture of the coracohumeral ligament and the rotator interval, which contributed to the condition.

Surgical release of these contracted structures, along with a proper exercise regimen, successfully relieved pain and restored shoulder motion in all patients over an average follow-up period of five years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathomechanics and operative management of chronic frozen shoulder. Ozaki, J.[2004]

In a study of 62 patients with idiopathic frozen shoulder, 50% still experienced mild pain or stiffness after an average follow-up of seven years, indicating that long-term recovery may be incomplete for some individuals.

Despite some patients showing improvement, 60% had restricted shoulder motion compared to healthy controls, with external rotation being the most commonly affected movement, suggesting that targeted rehabilitation may be necessary for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frozen shoulder. A long-term follow-up. Shaffer, B., Tibone, JE., Kerlan, RK.[2022]

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 75 patients with primary frozen shoulder, 66 underwent manipulation under anesthesia, with 25 requiring open surgical release due to failure of manipulation; this surgery showed significant improvement in pain and function after an average follow-up of 19.5 months.

Surgical release resulted in a substantial decrease in pain scores from 8.28 to 2.0 and a functional improvement from 6.08 to 18.9, particularly in patients without diabetes, highlighting the efficacy of this intervention for severe cases of frozen shoulder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open surgical release for frozen shoulder: surgical findings and results of the release. Omari, A., Bunker, TD.[2022]

The traditional treatment for stiff and painful shoulders, often seen in adhesive capsulitis and frozen shoulder, focuses on overhead mobilization, which can be painful and harmful to the shoulder joint.

This paper proposes a new biomechanical approach for evaluating and treating stiff and painful shoulders, aiming to improve patient outcomes without the risks associated with forced elevation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New concepts in restoring shoulder elevation in a stiff and painful shoulder patient. Donatelli, R., Ruivo, RM., Thurner, M., et al.[2014]

Extracorporeal shockwave therapy (ESWT) significantly improves pain relief and shoulder function in patients with frozen shoulder when used alongside routine treatments, as shown in a systematic review of 20 studies.

While ESWT provides immediate and short-term benefits, there is considerable variability in its effectiveness for long-term pain relief and range of motion, indicating the need for further research to clarify these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extracorporeal Shockwave Therapy as an Adjunctive Therapy for Frozen Shoulder: A Systematic Review and Meta-analysis. Zhang, R., Wang, Z., Liu, R., et al.[2022]

In a study of 28 subjects with frozen shoulder syndrome, both end-range mobilization (ERM) and mobilization with movement (MWM) showed significant improvements in shoulder mobility and function over 12 weeks.

MWM was particularly effective, as it not only improved overall mobility but also corrected scapulohumeral rhythm better than ERM, highlighting its potential as a preferred treatment technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobilization techniques in subjects with frozen shoulder syndrome: randomized multiple-treatment trial. Yang, JL., Chang, CW., Chen, SY., et al.[2022]

In a study of 85 patients with frozen shoulder, combining distention arthrography (DA) with translational mobilization (TM) resulted in significantly greater improvements in shoulder pain and range of motion compared to DA alone.

Both treatment methods were safe, with no serious complications reported, indicating that the combination therapy is an effective and safe option for managing frozen shoulder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Therapeutic Effectiveness Between Shoulder Distention Arthrography With Translation Mobilization and Distention Arthrography Alone in Patients With Frozen Shoulder. Park, GY., Kwon, DR., Kwon, DG., et al.[2022]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

Effectiveness of the end-range mobilization and scapular mobilization approach in a subgroup of subjects with frozen shoulder syndrome: a randomized control trial. [2022]

2. Finland pubmed.ncbi.nlm.nih.gov

Pathomechanics and operative management of chronic frozen shoulder. [2004]

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

Frozen shoulder. A long-term follow-up. [2022]

4. England pubmed.ncbi.nlm.nih.gov

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

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

Open surgical release for frozen shoulder: surgical findings and results of the release. [2022]

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

New concepts in restoring shoulder elevation in a stiff and painful shoulder patient. [2014]

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

Extracorporeal Shockwave Therapy as an Adjunctive Therapy for Frozen Shoulder: A Systematic Review and Meta-analysis. [2022]

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

Mobilization techniques in subjects with frozen shoulder syndrome: randomized multiple-treatment trial. [2022]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparison of Therapeutic Effectiveness Between Shoulder Distention Arthrography With Translation Mobilization and Distention Arthrography Alone in Patients With Frozen Shoulder. [2022]