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ERMI Shoulder Flexionater® for Frozen Shoulder

N/A

Recruiting

Research Sponsored by Foundation for Orthopaedic Research and Education

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Exhibits symptoms of adhesive capsulitis i. Shoulder pain with limited motion for more than one month ii. AND ≤ 30 degrees external rotation with arm at side iii. AND ≤ 130 degrees forward flexion d. Cortisone shot for all patients

Underwent a manipulation under anesthesia or a lysis of adhesions procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is studying three different treatments for shoulder stiffness: physical therapy alone, the ERMI Shoulder Flexionater alone, or physical therapy plus the device.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed here, generally such devices can cause discomfort or pain during use, potential muscle soreness afterwards similar to intense exercise effects on muscles and joints.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have had a procedure to break up scar tissue under anesthesia.

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I have had a shoulder arthroscopy procedure.

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I have undergone or will undergo a procedure to move my joints while I am asleep.

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I had surgery to fix a broken upper arm bone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

ASES Score

Shoulder Range of Motion

Shoulder Range of Motion Improvement

+2 more

Secondary outcome measures

Device Compliance Questionnaire (if applicable)

SST

Trial Design

3Treatment groups

Active Control

Group I: Adhesive Capsulitis StudyActive Control1 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 StudyActive Control1 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 StudyActive Control1 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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

ERMI, LLCUNKNOWN

Foundation for Orthopaedic Research and EducationLead Sponsor

13 Previous Clinical Trials

812 Total Patients Enrolled

Peter Simon, PhDStudy DirectorFoundation for Orthopaedic Research and Education

Media Library

Adhesive Capsulitis Study Clinical Trial Eligibility Overview. Trial Name: NCT05384093 — N/A

Frozen Shoulder Research Study Groups: Adhesive Capsulitis Study, Post operative Shoulder Stiffness Study, Secondary Surgery Study

Frozen Shoulder Clinical Trial 2023: Adhesive Capsulitis Study Highlights & Side Effects. Trial Name: NCT05384093 — N/A

Adhesive Capsulitis Study 2023 Treatment Timeline for Medical Study. Trial Name: NCT05384093 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research actively seeking new participants?

"Affirmative. According to clinicaltrials.gov, the study that was initiated on June 25th 2019 is actively seeking participants and requires 270 individuals from a single medical facility."

Answered by AI

How many individuals are taking part in this medical research?

"Affirmative. Clinicaltrials.gov is displaying that the trial, which was first announced on June 25th 2019, is still accepting applicants. A total of 270 patients are required at 1 site in order to move forward with this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Outcomes of Treatment Using the ERMI Shoulder Flexionater ®

2019. "Outcomes of Treatment Using the ERMI Shoulder Flexionater ®". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05384093.