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Outcomes of Treatment Using the ERMI Shoulder Flexionater ®

NCT05384093 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2025-08-07

No results posted yet for this study

Summary

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.

Conditions

  • Adhesive Capsulitis of Shoulder

Interventions

DEVICE

High Intensity Stretch Device

High Intensity Stretch and Physical Therapy are used either together or alone to treat study arm.

Sponsors & Collaborators

  • ERMI, LLC

    collaborator UNKNOWN

  • Foundation for Orthopaedic Research and Education

    lead OTHER

Principal Investigators

  • Peter Simon, PhD · Foundation for Orthopaedic Research and Education

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-25
Primary Completion
2025-10-25
Completion
2026-06-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05384093 on ClinicalTrials.gov