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Stretch device vs. physical therapy: which loosens a frozen shoulder?

NCT ID NCT05384093

Symptom relief Sponsor: Foundation for Orthopaedic Research and Education Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are comparing three ways to treat shoulder stiffness: physical therapy alone, the ERMI Shoulder Flexionater stretch device alone, and the device plus physical therapy. The trial includes people with frozen shoulder (adhesive capsulitis), people with stiffness after shoulder surgery, and people with stiffness after a procedure that releases the shoulder under anesthesia. The main goal is to see how much shoulder motion, pain, and daily function improve with each approach.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ERMI Shoulder Flexionater, a high-intensity shoulder stretch device, compared with physical therapy
What this could lead to
If the device helps, it could offer a home-based option for people with frozen shoulder or post-surgical stiffness, either on its own or alongside physical therapy.
What could go wrong
Stretching a stiff shoulder can be painful, and some people may not stick with the device. The trial may also show that the device works no better than physical therapy alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 210 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2019

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

bursitis frozen shoulder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adhesive capsulitis of shoulder

Contacts and locations

Locations

  • Foundation for Orthopaedic Research and Education

    Tampa, Florida, 33607, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.