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

Part of paid clinical trials in Plymouth, Minnesota.

Sponsor
Allina Health System
Study ID
NCT05095909
Status
Recruiting
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Conditions

  • Cryotherapy Effect
  • Rotator Cuff Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Cryo-compression — DEVICE
    Programmable intermittent compression with integrated cryo-therapy.
  • Cryo-therapy — OTHER
    Subjects are fitted with gel ice packs and wraps.

Study Details

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.

Key Dates

Start date
Aug 5, 2024
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Evaluation of pain levels in the post-operative period using VAS Pain Scale. [ Time Frame: up to 15 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Allina Health OrthopedicsPlymouthMinnesota55441
Ned K Tervola, MA, LAT, ATC
[email protected]
952-946-9777
L Pearce McCarty III, MD (PRINCIPAL_INVESTIGATOR)

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