Cryotherapy Following Rotator Cuff Repair Surgery

April 14, 2022 updated by: Robert J. Gillespie, University Hospitals Cleveland Medical Center
The purpose of this prospective crossover study is to determine if noninferiority exists in the use of the Thermazone cryotherapy machine when compared to Breg Polarcare, the current standard-of-care cryotherapy machine, for control of pain and reduction in postoperative narcotic medication consumption following arthroscopic rotator cuff repair surgery. Specifically, the investigators propose to test the hypothesis that in adults having arthroscopic rotator cuff repairs, the Thermazone device is non-inferior to Breg Polarcare on postoperative pain and opioid use over the initial 8 postoperative days.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Cryotherapy has traditionally been used for the acute treatment of musculoskeletal injuries and following operative procedures. Cryotherapy currently represents the standard of care following common orthopaedic procedures to the knee and shoulder. In addition to relieving pain and swelling during the acute inflammatory period following surgery, cryotherapy has also been shown to reduce muscle spasms, promoting quicker functional recovery, accelerating post-operative rehabilitation and return to regular activities. Multiple investigations have demonstrated the benefit of cryotherapy following both shoulder and knee surgeries when compared to ice alone or no cryotherapy, however conflicting data prevents consensual agreement regarding the success of cryotherapy when compared to other post-operative pain control modalities.

The use of cryotherapy has been extensively studied in the shoulder following operative procedures. Kraeutler et al. compared compressive cryotherapy versus ice alone, reporting no reduction in pain between the two modalities following arthroscopic rotator cuff repair or subacromial decompression. Singh et al. reported in their randomized controlled trial that patients undergoing arthroscopic procedures to the shoulder reported lower pain intensity on Days 1, 14 and 21 with the use of cryotherapy compared to patients in the non-cryotherapy group. Meanwhile, Speer et al. found in their prospective study that use of cryotherapy in the post-operative period was associated with reduced pain and swelling, decreased opioid use and better sleep quality following arthroscopic rotator cuff repair.

Similar results have been reported in patients treated with cryotherapy following anterior cruciate ligament reconstruction. Seacrist et al. performed a systematic review, identifying 10 randomized controlled trials investigating the effects of cryotherapy/compression on pain management following anterior cruciate ligament reconstruction. Cryotherapy was found to improve analgesia compared to patients treated without cryotherapy in 4 trials, while in 4 trials ice water and water at room temperature provided equivalent analgesic effects. Raynor et al. found in their meta-analysis that cryotherapy following anterior cruciate ligament reconstruction significantly improved post-operative pain control, while no improvements in postoperative range of motion or drainage were appreciated. Meanwhile, a combined cryotherapy-compression device was found to result in a significantly higher percentage of patients discontinuing narcotics 6 weeks post-operatively with a significantly greater decrease in VAS scores from pre-operative levels at 2 and 6 weeks post-operatively when compared to ice packs alone.

Adverse reactions to cryotherapy including frostbite, cutaneous necrosis and neuropathy are rare, but have been reported, necessitating the need for appropriate use guidelines, recognition and prevention.

As such, despite multiple studies examining the post-operative impact of cryotherapy following shoulder and knee procedures, no definitive conclusions on the effectiveness of cryotherapy on outcomes related to the use of post-operative analgesic medication, pain control, functional outcomes and range of motion have been determined. The conflicting reports regarding the benefit of cryotherapy may be related to the failure to achieve required decreases in intra-articular temperatures. Additional investigations are needed to better understand the impact of cryotherapy following arthroscopic rotator cuff, shoulder labral repair, anterior cruciate ligament reconstruction and meniscal repair/resection procedures.

Breg polarcare is a commonly used cryotherapy device that has a variety of clinical applications. The polarcare device requires ice and water, which is then circulated through a pad which the patient applies directly to the affected area. The Thermazone device does not require the use of ice and allows for osscilation between hot and cold temperatures. Currently, both cryotherapy devices are approved for use following surgery. However, no study to date has compared the Breg polarcare and thermazone devices in the context of arthroscopic rotator cuff surgery.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing primary arthroscopic rotator cuff repair.

Exclusion Criteria:

  • Patients with any of the following pre-existing medical conditions: Fibromyalgia; Complex regional pain syndrome; Any pain disorder that requires the patient to take narcotic pain medication in the pre-operative time period
  • Patients undergoing revision arthroscopic rotator cuff surgery
  • Illiterate, non-English speaking, and pregnant individuals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Breg Polarcare
Patients within the Breg Polarcare treatment arm will use the Breg Polarcare device for the first two days post-operatively following their arthroscopic rotator cuff repair. They will switch to the Thermazone device for post-operative days 3 and 4. They will continue to alternate every two days for 8 days total post-operatively.
Device: Breg Polarcare
The Breg Polarcare device is a type of cryotherapy machine that circulates ice cold water into a patch that can be worn by the patient on their affected joint (e.g., shoulder, knee).
Device: Thermazone
ThermaZone is a compact device that uses thermoelectric technology to provide heating and cooling therapy without the use of ice.
EXPERIMENTAL: Thermazone
Patients within the Thermazone treatment arm will use the Thermazone device for the first two days post-operatively following their arthroscopic rotator cuff repair. They will switch to the Breg Polarcare device for post-operative days 3 and 4. They will continue to alternate every two days for 8 days total post-operatively.
Device: Breg Polarcare
The Breg Polarcare device is a type of cryotherapy machine that circulates ice cold water into a patch that can be worn by the patient on their affected joint (e.g., shoulder, knee).
Device: Thermazone
ThermaZone is a compact device that uses thermoelectric technology to provide heating and cooling therapy without the use of ice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Visual Analog Scale
Time Frame: 2 weeks post-operatively
Scale from 0 to 10; 0 represents no pain and 10 represents the most amount of pain.
2 weeks post-operatively
Pain Visual Analog Scale
Time Frame: 6 weeks post-operatively
Scale from 0 to 10; 0 represents no pain and 10 represents the most amount of pain.
6 weeks post-operatively
American Shoulder and Elbow Surgeons (ASES) Score
Time Frame: 2 weeks post-operatively
Scale from 0 to 100 with higher scores representing better outcomes. The total score is weighted 50% for pain and 50% for function.
2 weeks post-operatively
American Shoulder and Elbow Surgeons (ASES) Score
Time Frame: 6 weeks post-operatively
Scale from 0 to 100 with higher scores representing better outcomes. The total score is weighted 50% for pain and 50% for function.
6 weeks post-operatively
Simple Shoulder Test (SST)
Time Frame: 2 weeks post-operatively
Scale ranges from 0% to 100% with higher scores representing better outcomes. Consists of a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. The answers to these questions provides a standardized way of recording the function of a shoulder before and after treatment.
2 weeks post-operatively
Simple Shoulder Test (SST)
Time Frame: 6 weeks post-operatively
Scale ranges from 0% to 100% with higher scores representing better outcomes. Consists of a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. The answers to these questions provides a standardized way of recording the function of a shoulder before and after treatment.
6 weeks post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse reactions from cryotherapy devices
Time Frame: 2 weeks post-operatively
The investigators will assess the rate of adverse reactions from the two cryotherapy devices and develop and adverse reaction profile.
2 weeks post-operatively
Adverse reactions from cryotherapy devices
Time Frame: 6 weeks post-operatively
The investigators will assess the rate of adverse reactions from the two cryotherapy devices and develop and adverse reaction profile.
6 weeks post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

Ohio Third Frontier
Innovative Medical Equipment, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2021

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

November 1, 2021

Study Registration Dates

First Submitted

January 8, 2021

First Submitted That Met QC Criteria

January 8, 2021

First Posted (ACTUAL)

January 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20200700

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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