Clinical Trial Finder

Outcomes of Treatment Using the ERMI Shoulder Flexionater ®

Study Purpose

Study 1

  • - Adhesive Capsulitis Study - 90 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05384093
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Foundation for Orthopaedic Research and Education
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Peter Simon, PhD
Principal Investigator Affiliation Foundation for Orthopaedic Research and Education
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Adhesive Capsulitis of Shoulder
Additional Details

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
  • - 90 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
  • - 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

Arms & Interventions

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.

Interventions

Device: - High Intensity Stretch Device

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tampa, Florida

Status

Recruiting

Address

Foundation for Orthopaedic Research and Education

Tampa, Florida, 33607

Site Contact

Deborah H Warren

[email protected]

813-978-9700 #6766

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