Comparing cryo-compression to traditional icing after rotator cuff surgery

Utility of Intermittent Cryo-Compression Versus Traditional Icing Following Arthroscopic Rotator Cuff Repair

This study is testing whether a new cryo-compression therapy can help people recovering from rotator cuff surgery manage their pain and swelling better than regular ice wraps.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Allina Health System (other)
• Locations: 1 site (Plymouth, Minnesota)
• Trial ID: NCT05095909 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are scheduled for arthroscopic rotator cuff repair and can provide informed consent.

Not a fit: Patients over the age of 70, those with significant joint osteoarthritis, or a history of opioid dependence may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved pain management and reduced opioid use for patients recovering from rotator cuff surgery.

How similar studies have performed: While the specific combination of cryo-compression has not been widely tested, similar studies exploring alternative pain management techniques have shown promising results.

Eligibility criteria

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 this trial is running

Plymouth, Minnesota

• Allina Health Orthopedics — Plymouth, Minnesota, United States (RECRUITING)

Study contacts

• Principal investigator: L Pearce McCarty III, MD — Allina Health
• Study coordinator: Ned Tervola, MA, LAT, ATC

Conditions: Rotator Cuff Injuries, Cryotherapy Effect, Cryo-compression, Rotator cuff repair