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Ice packs vs. opioids: cold therapy cuts painkiller use after shoulder surgery

NCT ID NCT07455474

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether using a cold compression device after arthroscopic rotator cuff repair surgery can help patients use fewer opioid painkillers. Fifty adults having shoulder surgery were randomly assigned to either standard care or standard care plus cold compression therapy. Researchers measured pain scores, sleep quality, and how much opioid medication each group used.

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

50 people

The number who actually took part.

Started

Oct 2023

Finished

Mar 2026

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * • Patients scheduled for arthroscopic rotator cuff surgical repair between the dates of July 17, 2023, and November 30, 2023 * Adult males and females ages 18 to 70 * No prior experience using the Breg Polar Care Wave device * No adverse underlying medical conditions or comorbidities that may enhance pain, require drugs that interact with opioids, or otherwise confound the results * Ownership of or daily access to a smart phone or internet-connected computer Exclusion Criteria: * • Patients scheduled for arthroscopic rotator cuff surgical repair outside the dates of July 17, 2023, and November 30, 2023 * Adults aged 71 and above * Children below the age of 18 * Other medical conditions or concomitant medication use that are known to negatively impact the outcome of rotator cuff repair o These include diabetes, current smoker, workers compensation claim, history of prior surgery on same shoulder, chronic pain, and pre-operative opioid use. Exclusion of this population is necessary in order to limit the introduction of confounding factors that could affect opioid usage independent of the Polar Care Wave. * Concurrent participation in other studies * Prior experience using the Breg Polar Care Wave device * Do not have daily access to an internet-connected device to provide study data

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Conditions

The condition(s) this trial relates to.

Pain, Postoperative Rotator Cuff Injuries rotator cuff syndrome

As listed by the trial registrant

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

Contacts and locations

Locations

  • Mammoth Hospital

    Mammoth Lakes, California, 93546, United States

  • Taos Orthopedic Institute

    Taos, New Mexico, 87571, United States

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