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Continuous Cryotherapy in Shoulder Arthroplasty Patients

NCT04861441 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-06-23

No results posted yet for this study

Summary

This is a randomized prospective study to test if cooling therapies decrease narcotic pain medication use in patients following total shoulder replacement surgery (total shoulder arthroplasty, TSA). Postoperative standard care involves use of ice packs placed on the surgical site for periods of approximately 20 minutes every 2 hours, but they do not provide consistent temperature and can become uncomfortably cold. Continuous cryotherapy (CC) machines provide flow of continuous cooled water (45-55° F) via a cuff placed on the affected sight for several hours. There are mixed results as to whether CC is more beneficial than standard ice pack therapy. This study will address whether CC decreases pain and narcotic pain medication use compared to ice pack therapy in TSA patients. The investigators will monitor both patient-reported pain scores and actual narcotic use to test the hypothesis that use of CC reduces postoperative pain and the need for narcotic pain medication. The results of this study may help establish parameters for non-pharmacologic intervention to reduce patient reliance on narcotic medications.

Conditions

  • Pain, Shoulder

Interventions

DEVICE

Aircast Cryo Cuff (Shoulder) and Aircast Cryo Cuff I/C Motorized Cooler

Patient will wear the continuous cryo cuff for a designated period of time and will record their pain and narcotic use post operatively.

DEVICE

Icepacks

Standard of care icepacks will be used postoperatively for designated amount of times and patients will record pain and narcotic use post operatively.

Sponsors & Collaborators

  • Lake Erie College of Osteopathic Medicine

    collaborator OTHER

  • D. Patrick Williams

    lead OTHER

Principal Investigators

  • D. Patrick Williams, DO · UPMC Hamot, Department of Orthopaedics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-22
Primary Completion
2022-06-24
Completion
2022-06-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04861441 on ClinicalTrials.gov