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Cryo-compression for Rotator Cuff Injury (ICC Trial)

N/A

Recruiting

Led By L. Pearce McCarty III, MD

Research Sponsored by Allina Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Acute, traumatic tear of the rotator cuff in an active patient

Patients who are candidates for arthroscopic rotator cuff repair

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

ICC Trial Summary

This trial will compare a new, non-invasive pain control method to the standard post-operative care to see if it is more effective.

Who is the study for?

This trial is for active patients over 18 with chronic or acute rotator cuff tears who haven't improved with non-surgical treatments and are candidates for arthroscopic repair. It's not suitable for those over 70, pregnant, obese (BMI >45), with a history of drug/alcohol addiction, opioid use, cold-related health issues like Raynaud's disease, significant arthritis in the joint, vascular impairments or lymphedema.Check my eligibility

What is being tested?

The study compares two post-operative pain control methods after arthroscopic rotator cuff surgery: a new cryo-compression therapy versus traditional ice wraps. The goal is to see if the novel method can better manage pain and reduce opioid use without side effects. Participants will be randomly assigned to one of these treatments.See study design

What are the potential side effects?

Potential side effects may include discomfort from the cold treatment such as numbness or skin irritation at the application site. There could also be risks associated with reduced blood flow due to extreme cold exposure in susceptible individuals.

ICC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I recently injured my shoulder's rotator cuff and I'm physically active.

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I am a candidate for a shoulder tendon repair surgery.

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I am 18 years old or older.

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I have a long-term shoulder injury that hasn't improved with treatment.

ICC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluation of pain levels in the post-operative period using Wong-Baker FACES Pain Scale.

Evaluation of post-operative edema comparing pre-operative and post-operative upper arm measurements.

Secondary outcome measures

Cost analysis of post-operative cryotherapy modalities and other historical controls of pain post-operative pain control.

Quality of life evaluation comparison of post-operative cryotherapy modalities using PROMIS Global-10 scale.

ICC Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cryo-compressionExperimental Treatment1 Intervention

Fitted with compression sleeve for the NICE Recovery SystemTM applied to the operative shoulder immediately post - operatively Minimum 6 hours treatment per day post-operatively. Utilize cyro-compression unit with a "Medium" compression level (inflate to 35 mmHg for 2 minutes and then deflate to 5 mmHg for 30 seconds) and "Level 3" cooling (50F (10C)) for the first 24 hours. After that time, the compression and cooling levels will be up to the patients' discretion.

Group II: Cryo-therapyActive Control1 Intervention

Fitted with a standard gel ice pack with wrap immediately post-operatively. Minimum 6 hours treatment per day using gel ice packs.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Allina Health SystemLead Sponsor

56 Previous Clinical Trials

1,175,114 Total Patients Enrolled

L. Pearce McCarty III, MDPrincipal InvestigatorAllina Health

L Pearce McCarty III, MDPrincipal InvestigatorAllina Health

Media Library

Cryo-compression Clinical Trial Eligibility Overview. Trial Name: NCT05095909 — N/A

Rotator Cuff Tears Research Study Groups: Cryo-compression, Cryo-therapy

Rotator Cuff Tears Clinical Trial 2023: Cryo-compression Highlights & Side Effects. Trial Name: NCT05095909 — N/A

Cryo-compression 2023 Treatment Timeline for Medical Study. Trial Name: NCT05095909 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently engaging in this trial?

"Affirmative. The clinicaltrial.gov listing for this medical study, initially posted on the 1st of June 2022, confirms that it is actively seeking participants. 100 volunteers are needed from a single site."

Answered by AI

Is my admittance to this clinical research possible?

"The current clinical trial is recruiting 100 individuals suffering from rotator cuff tears, with age restrictions of 18 to 70. Necessary criteria for eligibility involve chronic or acute symptomatic tears and the potentiality of arthroscopic repair."

Answered by AI

Is this medical trial open to persons above the age of seventy-five?

"This study is accepting applications from individuals aged 18 and above who have not yet reached their 70th birthdays."

Answered by AI

Are there still vacancies for participants in this research effort?

"The listing on clinicaltrials.gov confirms that this trial is actively enrolling participants, with the post first appearing on June 1st 2022 and the last update being made on June 16th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Utility of Intermittent Cryo-Compression Versus Traditional Icing Following Arthroscopic Rotator Cuff Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05095909.