Outcomes of Treatment Using the ERMI Shoulder Flexionater ®

Official title

Outcomes of Treatment Using the ERMI Shoulder Flexionater®

Overview

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

Interventions

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

Primary outcome measures

• Shoulder Range of Motion Improvement [Time frame: 3 months]
• Shoulder Range of Motion [Time frame: 6 months]
• Shoulder Range of Motion [Time frame: 12 months]
• Shoulder Range of Motion [Time frame: 24 months]
• Shoulder Range of Motion [Time frame: 6 weeks]
• Shoulder Range of Motion [Time frame: baseline]
• VAS (Visual Analog Scale) Pain Score [Time frame: 3 months]
• VAS Pain Score [Time frame: 6 weeks]
• VAS Pain Score [Time frame: 6 months]
• VAS Pain Score [Time frame: 12 months]

Secondary outcome measures (9)

• SST [Time frame: Baseline]
• SST [Time frame: 3 month]
• SST [Time frame: 6 weeks]
• SST [Time frame: 6 months]
• SST [Time frame: 12 months]
• SST [Time frame: 24 months]
• Device Compliance Questionnaire (if applicable) [Time frame: 6 weeks]
• Device Compliance Questionnaire (if applicable) [Time frame: 3 months]
• Device Compliance Questionnaire (if applicable) [Time frame: 6 months]

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?

• < 15 degrees external rotation with arm at side at 6 weeks post-op
• 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

• Shoulder arthroscopic procedures (29827, 29828, 29823,29824, 29826)
• ORIF Humerus fracture (23615)

For Study Group 3, Secondary Surgery Study (SAM)

Inclusion criteria

• 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

• Manipulation under anesthesia (23700)
• Lysis of adhesions (29825)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Foundation for Orthopaedic Research and Education — Tampa

Publications

• Teytelbaum DE, Kumar NS, Dent CS, Neaville S, Warren DH, Simon P, Baker CE. Efficacy of a high-intensity home stretching device and traditional physical therapy in non-operative management of adhesive capsulitis - a prospective, randomized control trial. BMC Musculoskelet Disord. 2024 Apr 20;25(1):305. doi: 10.1186/s12891-024-07448-4. PMID 38643086

Identifiers

NCT: NCT05384093 · FORE AC 2019

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗