Recruiting

Cryo-Compression

Sponsor:

Allina Health System

Code:

NCT05095909

Conditions

Rotator Cuff Injuries

Cryotherapy Effect

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Cryo-compression

Cryo-therapy

Study Details

Brief summary:

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

Rotator Cuff Injuries

Cryotherapy Effect

Study ID

NCT05095909

Start date

Aug 5, 2024

Status verified date

Sep, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cryo-compression

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.

active comparator: Cryo-therapy

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

Interventions

Cryo-compression

Programmable intermittent compression with integrated cryo-therapy.

Cryo-therapy

Subjects are fitted with gel ice packs and wraps.

Primary outcome measure

  • Evaluation of pain levels in the post-operative period using VAS Pain Scale. [ Time Frame: up to 15 days ]
  • Evaluation of post-operative edema comparing pre-operative and post-operative upper arm measurements. [ Time Frame: up to 15 days ]

Central Contacts and Locations

Central contacts

Ned Tervola, MA, LAT, ATC

952-946-9777ned.tervola@allina.com

Locations

Allina Health Orthopedics

Recruiting

Plymouth, Minnesota, United States, 55441

Contacts

Ned K Tervola, MA, LAT, ATC

952-946-9777ned.tervola@allina.com

Principal Investigator:

L Pearce McCarty III, MD

More Information

Sponsor

Allina Health System

Last update posted

Jan 27, 2026

Last verified

Sep, 2025

Keywords

  • Cryo-compression
  • Rotator cuff repair

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Allina Health System on 2026-01-27.