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Ice and wrap after shoulder surgery: simple relief?

NCT ID NCT07516327

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 using cold and compression after rotator cuff repair surgery reduces pain better than standard care. About 90 adults with partial or full-thickness rotator cuff tears will be randomly assigned to either a cold/compression device or usual care. Pain levels will be tracked for 6 months after surgery.

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 90 people

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

Started

Mar 2026

Expected to finish

Aug 2029

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

35 years and older

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: 1. Aged 35 yr or older 2. Patient of Drs. Michael Hartman (PI), Ian Elliott, Jay French, or Paul Phillips at Ochsner Kenner scheduled for arthroscopic rotator cuff repair 3. Will receive outpatient physical therapy at OTW Driftwood for the entire post-op rehabilitation period 4. English speaking 5. Diagnosis of high-grade partial or full thickness rotator cuff tears Exclusion Criteria: 1. Chronic opioid use 2. Opioid use within the last 3 months 3. Diagnosis of inflammatory disease process (i.e., gout, rheumatoid arthritis, systematic lupus erythematosus...) 4. Discharge to skilled nursing 5. Cold intolerance related to diseases, like Raynaud's 6. Significant vascular impairment in the affected region 7. Current clinical signs of inflammatory phlebitis, venous ulcers, or cellulitis 8. Significant risk factors or current clinical signs of embolism (e.g., pulmonary embolus, pulmonary edema, cerebral infarction, atrial fibrillation, endocarditis, myocardial infarction, or atheromatous embolic plaque) 9. A condition in which increased venous or lymphatic return is not desired in the affected extremity (e.g., lymphedema after breast cancer or other local carcinoma and/or carcinoma metastasis in the affected extremity). 10. Uncontrolled hypertension (physician discretion), cardiac failure, extreme low blood pressure, or decompensated cardiac insufficiency. 11. Localized unstable skin condition (e.g., dermatitis, vein ligation, gangrene, or recent skin graft) in the affected region. 12. Had recent toe surgery in the affected region 13. Current clinical signs in the affected region of significant peripheral edema (e.g., deep vein thrombosis, chronic venous insufficiency, acute compartment syndrome, systemic venous hypertension, congestive heart failure, cirrhosis/liver failure, renal failure). 14. An acute, unstable (untreated) fracture in the affected region. 15. Any active local or systemic infection. 16. Obtunded or with diabetes mellitus, multiple sclerosis, poor circulation, spinal cord injuries, and rheumatoid arthritis 17. Areas of skin breakdown or damage (damaged or at-risk skin) producing uneven heat conduction across the skin (e.g., open wound, scar tissue, burn or skin graft). Any open wound must be dressed prior to use of the Polar Care Wave System. 18. Presumptive evidence of congestive heart failure 19. Pre-existing DVT condition 20. Deep acute venal thrombosis (Phlebothrombosis) 21. Episodes of pulmonary embolism 22. Pulmonary edema 23. Acute inflammation of the veins (Thrombophlebitis) 24. Decompensated cardiac insufficiency 25. Arterial dysregulation 26. Erysipelas 27. Carcinoma and carcinoma metastasis in the affected extremity 28. Decompensated hypertonia 29. Acute inflammatory skin diseases or infection 30. Venous or arterial occlusive disease 31. Medical situations where increased venous or lymphatic return is undesirable 32. Poor peripheral circulation 33. Severe arteriosclerosis, or active infection 34. Known hematological dyscrasias that predispose to thrombosis (e.g., paroxysmal cold hemoglobinuria, cryoglobulinemia, sicklecell disease, serum cold agglutinins). 35. Tissues inflamed as a result of recent injury or exacerbation of chronic inflammatory condition. 36. Compromised local circulation or neurologic impairment (including paralysis or localized compromise due to multiple surgical procedures or diabetes) in the affected region. 37. Cognition or communication impairments that prevent them from giving accurate and timely feedback. 38. Cold allergy 39. Cold agglutinin disorders like paroxysmal cold hemoglobinuria 40. Buerger's disease 41. Chilblains 42. Cryoglobulinemia 43. Sickle cell anemia 44. Uncontrolled diabetes (physician discretion) 45. Hypersensitivity to cold

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Conditions

The condition(s) this trial relates to.

Acute Pain Pain, Postoperative rotator cuff syndrome

As listed by the trial registrant

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

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

  • Ochsner Medical Center - Kenner

    RECRUITING

    Kenner, Louisiana, 70065, United States