Outcomes of Treatment Using the ERMI Shoulder Flexionater ®

Conditions

• Adhesive Capsulitis of Shoulder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jun 25, 2019

Status verified

Aug 2025

Primary completion

Oct 25, 2025

Completion

Jun 25, 2026

Study Design

Enrollment

210 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Adhesive Capsulitis Study
  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.
• Active Comparator: Post operative Shoulder Stiffness Study
  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.
• Active Comparator: Secondary Surgery Study
  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.

Primary Outcome Measure

Shoulder Range of Motion Improvement [ Time Frame: 3 months ]

Central Contacts

• Deborah H Warren, RN
  8139789700
  [email protected]
• Viki Sochor
  813-978-9700
  [email protected]

Locations (1)

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