Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT05384093
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.
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
Study:
NCT05384093
Study Brief:
Protocol Section:
NCT05384093