Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:33 PM
Study NCT ID:
NCT05384093
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2022-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcomes of Treatment Using the ERMI Shoulder Flexionater ®
Sponsor:
Foundation for Orthopaedic Research and Education
Organization:
Study Overview
Official Title:
Outcomes of Treatment Using the ERMI Shoulder Flexionater®
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
Study 1 - Adhesive Capsulitis Study (AC)
Objective: 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.
1. Prospective randomized control trial
2. Sample size - 110 patients
3. Study Groups:
1. Group I - Physical Therapy Only
2. Group II - Flexionater® only
3. Group III - Flexionater® and Physical Therapy
4. Length of study - 2-year follow-up from last enrolled patient
Study 2 - Postoperative Shoulder Stiffness Study (POS)
Objective: 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.
1. Prospective randomized control trial
2. Sample size - 90 enrolled patients
3. Study Groups:
1. Group I - Physical Therapy only
2. Group II - Flexionater® only
3. Group III - Flexionater® and Physical Therapy
4. Length of study - 2-year follow-up from last enrolled patient
Study 3 - Secondary Surgery Study (SAM)
Objective: 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.
1. Prospective randomized control trial
2. Sample size - 10 enrolled patients
3. Study Groups:
1. Group I Physical Therapy Only
2. Group II - - Flexionater® only
3. Group III - Flexionater® and Physical Therapy
4. Length of study - 2-year follow-up from last enrolled patient
Objective: 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.
1. Prospective randomized control trial
2. Sample size - 110 patients
3. Study Groups:
1. Group I - Physical Therapy Only
2. Group II - Flexionater® only
3. Group III - Flexionater® and Physical Therapy
4. Length of study - 2-year follow-up from last enrolled patient
Study 2 - Postoperative Shoulder Stiffness Study (POS)
Objective: 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.
1. Prospective randomized control trial
2. Sample size - 90 enrolled patients
3. Study Groups:
1. Group I - Physical Therapy only
2. Group II - Flexionater® only
3. Group III - Flexionater® and Physical Therapy
4. Length of study - 2-year follow-up from last enrolled patient
Study 3 - Secondary Surgery Study (SAM)
Objective: 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.
1. Prospective randomized control trial
2. Sample size - 10 enrolled patients
3. Study Groups:
1. Group I Physical Therapy Only
2. Group II - - Flexionater® only
3. Group III - Flexionater® and Physical Therapy
4. Length of study - 2-year follow-up from last enrolled patient
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: