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New cold therapy could cut opioid use after shoulder surgery

NCT ID NCT05095909

Symptom relief Sponsor: Allina Health System Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a special cold compression machine works better than regular ice packs for pain and swelling after arthroscopic rotator cuff repair. About 100 adults having this shoulder surgery will be randomly assigned to one of the two cooling methods. The goal is to see if the device improves pain control, reduces swelling, and lowers the need for opioid painkillers.

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 100 people

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

Started

Aug 2024

Expected to finish

Dec 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 to 70 years

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.

Inclusion Criteria: 1. Patients who are candidates for arthroscopic rotator cuff repair 1. Acute, traumatic tear of the rotator cuff in an active patient 2. Chronic, symptomatic tear of the rotator cuff in an active patient having failed non - operative treatment 2. Patient agreeable to participation in the study and able to complete informed consent process and all study requirements. 3. ≥18 years of age Exclusion Criteria: 1. Pregnancy (per pre-operative physical) 2. Presence of significant glenohumeral joint osteoarthritis 3. Age over 70 4. History of clinically diagnosed lymphedema 5. Morbid obesity (BMI \> 45) 6. History of drug or alcohol addiction, prior opioid dependence, or current use of opioid medication (preoperative) 7. Investigators concern regarding subject's ability or willingness to follow protocol. 8. History of significant vascular impairment in the affected region (e.g., from prior frostbite, diabetes, arteriosclerosis or ischemia). 9. History of acute paroxysmal cold hemoglobinuria or cryoglobulinemia. 10. History of Raynaud's disease or cold hypersensitivity (cold urticarial).

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Conditions

The condition(s) this trial relates to.

Rotator Cuff Injuries rotator cuff syndrome

As listed by the trial registrant

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

Cryotherapy effect Rotator cuff injuries

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allina Health Orthopedics

    RECRUITING

    Plymouth, Minnesota, 55441, United States

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