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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jun 2019Jun 2026

Study Start

First participant enrolled

June 25, 2019

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2026

Expected
Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

6.3 years

First QC Date

May 3, 2022

Last Update Submit

August 4, 2025

Conditions

Adhesive Capsulitis of Shoulder

Outcome Measures

Primary Outcomes (18)

  • Shoulder Range of Motion Improvement

    Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice

    3 months

  • Shoulder Range of Motion

    Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice

    6 months

  • Shoulder Range of Motion

    Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice

    12 months

  • Shoulder Range of Motion

    Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice

    24 months

  • Shoulder Range of Motion

    Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice

    6 weeks

  • Shoulder Range of Motion

    Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice

    baseline

  • VAS (Visual Analog Scale) Pain Score

    Visual Analog Scale Pain Score 0 (no pain) - 10 (pain as bad as it can be)

    3 months

  • VAS Pain Score

    Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)

    6 weeks

  • VAS Pain Score

    Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)

    6 months

  • VAS Pain Score

    Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)

    12 months

  • VAS Pain Score

    Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)

    24 months

  • VAS Pain Score

    Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)

    baseline

  • ASES Score

    American Shoulder and Elbow Society Score (10 activities of daily living are calculated)

    baseline

  • ASES Score

    American Shoulder and Elbow Society Score (10 activities of daily living are calculated)

    3 month

  • ASES Score

    American Shoulder and Elbow Society Score (10 activities of daily living are calculated)

    6 weeks

  • ASES Score

    American Shoulder and Elbow Society Score (10 activities of daily living are calculated)

    6 months

  • ASES Score

    American Shoulder and Elbow Society Score (10 activities of daily living are calculated)

    12 months

  • ASES Score

    American Shoulder and Elbow Society Score (10 activities of daily living are calculated)

    24 months

Secondary Outcomes (9)

  • SST

    Baseline

  • SST

    3 month

  • SST

    6 weeks

  • SST

    6 months

  • SST

    12 months

  • +4 more secondary outcomes

Study Arms (3)

Adhesive Capsulitis Study

ACTIVE COMPARATOR

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.

Device: High Intensity Stretch Device

Post operative Shoulder Stiffness Study

ACTIVE COMPARATOR

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.

Device: High Intensity Stretch Device

Secondary Surgery Study

ACTIVE COMPARATOR

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.

Device: High Intensity Stretch Device

Interventions

High Intensity Stretch DeviceDEVICE

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

Also known as: Physical Therapy
Adhesive Capsulitis StudyPost operative Shoulder Stiffness StudySecondary Surgery Study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • \< 15 degrees external rotation with arm at side at 6 weeks post-op
  • a. Revision surgery b. Infection c. Rheumatoid arthritis
  • \. Procedures included
  • Shoulder arthroscopic procedures (29827, 29828, 29823,29824, 29826)
  • ORIF Humerus fracture (23615)
  • For Study Group 3, Secondary Surgery Study (SAM)
  • Underwent a manipulation under anesthesia or a lysis of adhesions procedure
  • 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
  • \. Procedures included
  • Manipulation under anesthesia (23700)
  • Lysis of adhesions (29825)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation for Orthopaedic Research and Education

Tampa, Florida, 33607, United States

RECRUITING

Related Publications (1)

  • 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: 38643086DERIVED

MeSH Terms

Conditions

Bursitis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Peter Simon, PhD

    Foundation for Orthopaedic Research and Education

    STUDY DIRECTOR

Central Study Contacts

Deborah H Warren, RN

CONTACT

8139789700dwarren@foreonline.org

Viki Sochor

CONTACT

813-978-9700vsochor@foreonline.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2022

First Posted

May 20, 2022

Study Start

June 25, 2019

Primary Completion

October 25, 2025

Study Completion (Estimated)

June 25, 2026

Last Updated

August 7, 2025

Record last verified: 2025-08

Locations

US(1)