Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT05095909

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

Led by Allina Health System · Updated on 2026-01-27

100

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Effective post - operative pain control following orthopedic surgical procedures without excessive reliance upon opioid pain medication has garnered increased attention in recent years. This study will evaluate the utilization of a non-invasive, novel cryo - compression, post-operative modality to improve pain control versus standard ice wraps in the immediate post-operative phase of arthroscopic rotator cuff surgery via a randomized controlled study design. Furthermore, if this study demonstrates improved pain control, improved quality of life and decreased opioid usage with the intermittent cold compression unit, recommendations may be considered for system-wide utilization.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who are candidates for arthroscopic rotator cuff repair
  • Acute, traumatic tear of the rotator cuff in an active patient
  • Chronic, symptomatic tear of the rotator cuff in an active patient having failed non-operative treatment
  • Patient agreeable to participation in the study and able to complete informed consent process and all study requirements
  • 18 years of age or older
Not Eligible

You will not qualify if you...

  • Pregnancy confirmed by pre-operative physical examination
  • Presence of significant glenohumeral joint osteoarthritis
  • Age over 70 years
  • History of clinically diagnosed lymphedema
  • Morbid obesity with body mass index greater than 45
  • History of drug or alcohol addiction, prior opioid dependence, or current use of opioid medication before surgery
  • Investigator concerns about subject's ability or willingness to follow the study protocol
  • History of significant vascular impairment in the affected region such as from frostbite, diabetes, arteriosclerosis, or ischemia
  • History of acute paroxysmal cold hemoglobinuria or cryoglobulinemia
  • History of Raynaud's disease or cold hypersensitivity (cold urticaria)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Allina Health Orthopedics

Plymouth, Minnesota, United States, 55441

Actively Recruiting

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Research Team

N

Ned Tervola, MA, LAT, ATC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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