Clinical trial NCT05384093: Outcomes of Treatment Using the ERMI Shoulder Flexionater ®
Official title: Outcomes of Treatment Using the ERMI Shoulder Flexionater®
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adhesive Capsulitis of Shoulder
Lead sponsor: Foundation for Orthopaedic Research and Education
Sponsor class: OTHER
Collaborators: name: ERMI, LLC
First posted: 2022-05-20
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: For Study Group 1- Adhesive Capsulitis (AC)

Inclusion Criteria:

* 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

Exclusion Criteria:

* a. No prior shoulder surgery b. Infection c. Rheumatoid arthritis d. Any structural or systemic disorder that could result in pain or ROM limitation i. Such as inflammatory joint disease, osteoarthritis evidenced on radiographs ii. full thickness rotator cuff tear as shown by ultrasound imaging iii. history of major trauma or surgery involving the shoulder

For Study Group 2 - Postoperative Shoulder Stiffness Study (POS)

Inclusion Criteria:

c. Is not recovering normally based on objective criteria set for screening process i. Step 1 - Follow patients -all post-op patients with indicated procedures (see # 7 for list.) ii. Step 2 - Screen Patients -does patient meets inclusion criteria at 6 weeks or 3 months of follow-up?

1. \< 15 degrees external rotation with arm at side at 6 weeks post-op
2. OR \< 90 degrees forward flexion at 3 months post-op iii. Step 3 - Enroll patients that meet inclusion criteria and assign group

Exclusion Criteria:

a. Revision surgery b. Infection c. Rheumatoid arthritis

7. Procedures included

1. Shoulder arthroscopic procedures (29827, 29828, 29823,29824, 29826)
2. ORIF Humerus fracture (23615)

   For Study Group 3, Secondary Surgery Study (SAM)

   Inclusion Criteria:
3. Underwent a manipulation under anesthesia or a lysis of adhesions procedure

Exclusion Criteria:

a. Infection b. Rheumatoid arthritis c. Any structural or systemic disorder that could result in pain or ROM limitation i. Such as inflammatory joint disease, osteoarthritis evidenced on radiographs ii. full thickness rotator cuff tear as shown by ultrasound imaging iii. history of major trauma or surgery involving the shoulder

7. Procedures included

1. Manipulation under anesthesia (23700)
2. Lysis of adhesions (29825)

Primary outcomes:
measure: Shoulder Range of Motion Improvement
timeFrame: 3 months
measure: Shoulder Range of Motion
timeFrame: 6 months
measure: Shoulder Range of Motion
timeFrame: 12 months
measure: Shoulder Range of Motion
timeFrame: 24 months
measure: Shoulder Range of Motion
timeFrame: 6 weeks
measure: Shoulder Range of Motion
timeFrame: baseline
measure: VAS (Visual Analog Scale) Pain Score
timeFrame: 3 months
measure: VAS Pain Score
timeFrame: 6 weeks
measure: VAS Pain Score
timeFrame: 6 months
measure: VAS Pain Score
timeFrame: 12 months
measure: VAS Pain Score
timeFrame: 24 months
measure: VAS Pain Score
timeFrame: baseline
measure: ASES Score
timeFrame: baseline
measure: ASES Score
timeFrame: 3 month
measure: ASES Score
timeFrame: 6 weeks
measure: ASES Score
timeFrame: 6 months
measure: ASES Score
timeFrame: 12 months
measure: ASES Score
timeFrame: 24 months
Secondary outcomes:
measure: SST
timeFrame: Baseline
measure: SST
timeFrame: 3 month
measure: SST
timeFrame: 6 weeks
measure: SST
timeFrame: 6 months
measure: SST
timeFrame: 12 months
measure: SST
timeFrame: 24 months
measure: Device Compliance Questionnaire (if applicable)
timeFrame: 6 weeks
measure: Device Compliance Questionnaire (if applicable)
timeFrame: 3 months
measure: Device Compliance Questionnaire (if applicable)
timeFrame: 6 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Foundation for Orthopaedic Research and Education
state: Florida
Study officials:
affiliation: Foundation for Orthopaedic Research and Education
name: Peter Simon, PhD
role: STUDY_DIRECTOR
References: