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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to assist individuals with frozen shoulder, a condition causing painful and limited shoulder movement. It compares three treatment approaches: physical therapy alone, the ERMI Shoulder Flexionater® (a specialized device for improving shoulder movement) alone, and a combination of both. Participants will be grouped based on specific shoulder issues, such as adhesive capsulitis (frozen shoulder) or post-surgical stiffness. Those who have experienced shoulder pain with limited movement for over a month or have undergone certain shoulder surgeries may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to investigate innovative treatments for shoulder issues.

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 prior data suggests that the ERMI Shoulder Flexionater® is safe for treating adhesive capsulitis and postoperative shoulder stiffness?

Research has shown that the ERMI Shoulder Flexionater® is generally safe for treating frozen shoulder. One study involving 36 patients found the device both safe and effective for addressing movement loss due to frozen shoulder. Another study examined its use for stiffness after shoulder surgery and found that high-intensity stretch therapy, such as the Flexionater, was a safe option. These findings suggest the device is well-tolerated for shoulder issues. Significant negative side effects have not been reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

The ERMI Shoulder Flexionater® is unique because it offers a focused approach to treating frozen shoulder, aiming to enhance flexibility and reduce pain more effectively than traditional methods like physical therapy alone. Unlike standard care, which primarily relies on exercises and manual manipulation, the Flexionater provides a controlled mechanical stretch to the joint, potentially speeding up recovery. Researchers are excited about this device because it could offer a more efficient and consistent improvement in shoulder mobility, helping patients regain their range of motion faster and with less discomfort.

What evidence suggests that the ERMI Shoulder Flexionater® is effective for treating adhesive capsulitis?

This trial will compare treatment efficacy for frozen shoulder, also known as adhesive capsulitis, across different groups. Research has shown that the ERMI Shoulder Flexionater® effectively treats this condition. In studies, this device improved shoulder movement in 97% of patients, helping them avoid further surgery. Participants in this trial may receive treatment with the ERMI Shoulder Flexionater® alone, in combination with physical therapy, or physical therapy alone. Another study found that the device greatly improved shoulder function and flexibility. These results suggest that the ERMI Shoulder Flexionater® could be a good option for those dealing with shoulder stiffness and pain. ^{1 3 4 6 7}

Who Is on the Research Team?

Peter Simon, PhD

Principal Investigator

Foundation for Orthopaedic Research and Education

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9524064/

Efficacy of high-intensity home mechanical stretch therapy ... The HIS device was shown to be effective in treating patients with shoulder motion loss due to adhesive capsulitis as demonstrated by the significant ROM gains ...

2. ermi-motion.com ermi-motion.com/clinical-evidence/

ERMI Devices | Peer-reviewed studies showing 90% success 97% of patients were able to avoid additional surgery to treat their motion loss. · The Ermi device was successful in treating adhesive capsulitis regardless of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11031861/

Efficacy of a high-intensity home stretching device and ... Patients continued physical therapy until the affected shoulder achieved external rotation and forward flexion ROM equal to or greater than 90% ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05384093

NCT05384093 | Outcomes of Treatment Using the ERMI ... The purpose of this study is to compare treatment efficacy of patients with post-operative stiffness indicative of secondary adhesive capsulitis between three ...

5. withpower.com withpower.com/trial/ermi-shoulder-flexionater-for-frozen-shoulder-78c47

ERMI Shoulder Flexionater® for Frozen Shoulder In a study of 34 subjects, those receiving EMSMTA showed greater enhancements in shoulder kinematics and function, indicating that this targeted treatment may ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1877065716300628

High-intensity stretch treatment for severe postoperative ... We aimed to evaluate therapy for postoperative adhesive capsulitis of the shoulder in 2 groups of patients: (1) those who used a high-intensity stretch ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05384093?cond=Adhesive%20capsulitis%20of%20shoulder&aggFilters=status:not%20rec%20ava&rank=7

Outcomes of Treatment Using the ERMI Shoulder Flexionater Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...