Continuous Cryotherapy in Shoulder Arthroplasty Patients

NCT04861441 | Withdrawn FDA Device

• 1 other identifier: STUDY20100056
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Continuous monitoring of pain control

  Pain control will be self reported using a visual analog scale (VAS) for pain. The scale will be from 1 to 10 with 1 being being less severe pain and 10 being more severe pain

  Up to post operative day 28

• Continuous monitoring of narcotic use

  Subjects will record narcotic post operatively and this will be converted to morphine equivalents.

  Up to post operative day 28

Study Arms (2)

Continuous Cryotherapy

EXPERIMENTAL

Subjects will use continuous cryotherapy post operative for pain control

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

Icepack

ACTIVE COMPARATOR

Subjects will use standard icepacks post operative for pain control

Device: Icepacks

Interventions

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

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

Continuous Cryotherapy

Icepacks DEVICE

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

Icepack

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the age of 55 and 80 who are indicated for a TSA, including both anatomic (maintaining anatomic location of the ball and socket in the shoulder) and reverse (reverses where the ball and socked are placed) total shoulder arthroplasties.

You may not qualify if:

• Patients undergoing:
• revision total shoulder arthroplasty
• TSA for a fracture
• Patients with a history of narcotic abuse.
• Patients unwilling or unable to receive and interscalene block
• Patients with Raynaud's disease, vasospastic disease, or other circulatory dysfunction
• Patients with cold hypersensitivity, decreased skin sensitivity related to temperature
• Patients with central ports, PICC lines, or other indwelling IV access on the affected side.

Sponsors & Collaborators

• D. Patrick Williams: lead
• Lake Erie College of Osteopathic Medicine: collaborator

Study Sites (1)

UPMC Hamot

Erie, Pennsylvania, 16550, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• D. Patrick Williams, DO

  UPMC Hamot, Department of Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: October 22, 2021
• Primary Completion: June 24, 2022
• Study Completion: June 24, 2022
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)