Comparing cryo-compression to traditional icing after rotator cuff surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of intermittent cryo-compression therapy compared to standard ice wraps for managing post-operative pain and swelling in patients undergoing arthroscopic rotator cuff repair. It aims to assess pain control through patient-reported visual analog scores and opioid usage, as well as the impact on quality of life. The study will enroll 100 subjects and utilize a randomized controlled design to gather data on the efficacy and cost-effectiveness of the cryo-compression method.

Why it matters

Who can join: the full rules

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).

Where it's running

• Allina Health Orthopedics
  Plymouth, Minnesota, United States Recruiting

Study contacts

• Principal investigator: L Pearce McCarty III, MD — Allina Health System
• Study coordinator: Ned Tervola, MA, LAT, ATC
• Email: ned.tervola@allina.com
• Phone: 952-946-9777

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.