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Cryotherapy Following Rotator Cuff Repair Surgery

Primary Purpose

Rotator Cuff Tears

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breg Polarcare
Thermazone
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rotator Cuff Tears focused on measuring Arthroscopy, Opioid Use

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Cleveland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Breg Polarcare

Thermazone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain Visual Analog Scale
Scale from 0 to 10; 0 represents no pain and 10 represents the most amount of pain.
Pain Visual Analog Scale
Scale from 0 to 10; 0 represents no pain and 10 represents the most amount of pain.
American Shoulder and Elbow Surgeons (ASES) Score
Scale from 0 to 100 with higher scores representing better outcomes. The total score is weighted 50% for pain and 50% for function.
American Shoulder and Elbow Surgeons (ASES) Score
Scale from 0 to 100 with higher scores representing better outcomes. The total score is weighted 50% for pain and 50% for function.
Simple Shoulder Test (SST)
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.
Simple Shoulder Test (SST)
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.

Secondary Outcome Measures

Adverse reactions from cryotherapy devices
The investigators will assess the rate of adverse reactions from the two cryotherapy devices and develop and adverse reaction profile.
Adverse reactions from cryotherapy devices
The investigators will assess the rate of adverse reactions from the two cryotherapy devices and develop and adverse reaction profile.

Full Information

First Posted
January 8, 2021
Last Updated
April 14, 2022
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Innovative Medical Equipment, LLC, Ohio Third Frontier
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1. Study Identification

Unique Protocol Identification Number
NCT04705376
Brief Title
Cryotherapy Following Rotator Cuff Repair Surgery
Official Title
Cryotherapy Following Rotator Cuff Repair Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Funding
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
November 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Innovative Medical Equipment, LLC, Ohio Third Frontier

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
Keywords
Arthroscopy, Opioid Use

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The investigators propose a randomized crossover trial involving the use cryotherapy machines as a means of pain control following arthroscopic rotator cuff repair surgery. Patients will be randomized into receiving one of two possible cryotherapy devices immediately after surgery: Breg Polarcare or Thermazone. Randomization will occur with the use of a randomization excel spreadsheet. On post-operative day 3, patients who were originally randomized to Breg will then use Thermazone and patients who were randomized to Thermazone will use Breg for post-operative days 3 and 4. Both groups will alternate between both cryotherapy devices every two days post-operatively for 8 days total. Both groups will maintain a pain journal during the 8 study days post-operatively to document VAS scores, number of narcotic pain medications taken, and any adverse reactions from the cryotherapy devices. At 2 and 6-weeks follow-up, both groups will complete a functional evaluation.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breg Polarcare
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Thermazone
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Breg Polarcare
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Thermazone
Intervention Description
ThermaZone is a compact device that uses thermoelectric technology to provide heating and cooling therapy without the use of ice.
Primary Outcome Measure Information:
Title
Pain Visual Analog Scale
Description
Scale from 0 to 10; 0 represents no pain and 10 represents the most amount of pain.
Time Frame
2 weeks post-operatively
Title
Pain Visual Analog Scale
Description
Scale from 0 to 10; 0 represents no pain and 10 represents the most amount of pain.
Time Frame
6 weeks post-operatively
Title
American Shoulder and Elbow Surgeons (ASES) Score
Description
Scale from 0 to 100 with higher scores representing better outcomes. The total score is weighted 50% for pain and 50% for function.
Time Frame
2 weeks post-operatively
Title
American Shoulder and Elbow Surgeons (ASES) Score
Description
Scale from 0 to 100 with higher scores representing better outcomes. The total score is weighted 50% for pain and 50% for function.
Time Frame
6 weeks post-operatively
Title
Simple Shoulder Test (SST)
Description
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.
Time Frame
2 weeks post-operatively
Title
Simple Shoulder Test (SST)
Description
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.
Time Frame
6 weeks post-operatively
Secondary Outcome Measure Information:
Title
Adverse reactions from cryotherapy devices
Description
The investigators will assess the rate of adverse reactions from the two cryotherapy devices and develop and adverse reaction profile.
Time Frame
2 weeks post-operatively
Title
Adverse reactions from cryotherapy devices
Description
The investigators will assess the rate of adverse reactions from the two cryotherapy devices and develop and adverse reaction profile.
Time Frame
6 weeks post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24562697
Citation
Khoshnevis S, Craik NK, Diller KR. Cold-induced vasoconstriction may persist long after cooling ends: an evaluation of multiple cryotherapy units. Knee Surg Sports Traumatol Arthrosc. 2015 Sep;23(9):2475-83. doi: 10.1007/s00167-014-2911-y. Epub 2014 Feb 23.
Results Reference
background
PubMed Identifier
25825138
Citation
Kraeutler MJ, Reynolds KA, Long C, McCarty EC. Compressive cryotherapy versus ice-a prospective, randomized study on postoperative pain in patients undergoing arthroscopic rotator cuff repair or subacromial decompression. J Shoulder Elbow Surg. 2015 Jun;24(6):854-9. doi: 10.1016/j.jse.2015.02.004. Epub 2015 Mar 29.
Results Reference
background
PubMed Identifier
15915833
Citation
Raynor MC, Pietrobon R, Guller U, Higgins LD. Cryotherapy after ACL reconstruction: a meta-analysis. J Knee Surg. 2005 Apr;18(2):123-9. doi: 10.1055/s-0030-1248169.
Results Reference
background
PubMed Identifier
26684664
Citation
Secrist ES, Freedman KB, Ciccotti MG, Mazur DW, Hammoud S. Pain Management After Outpatient Anterior Cruciate Ligament Reconstruction: A Systematic Review of Randomized Controlled Trials. Am J Sports Med. 2016 Sep;44(9):2435-47. doi: 10.1177/0363546515617737. Epub 2015 Dec 18.
Results Reference
background
PubMed Identifier
27462522
Citation
Song M, Sun X, Tian X, Zhang X, Shi T, Sun R, Dai W. Compressive cryotherapy versus cryotherapy alone in patients undergoing knee surgery: a meta-analysis. Springerplus. 2016 Jul 13;5(1):1074. doi: 10.1186/s40064-016-2690-7. eCollection 2016.
Results Reference
background
PubMed Identifier
8919444
Citation
Speer KP, Warren RF, Horowitz L. The efficacy of cryotherapy in the postoperative shoulder. J Shoulder Elbow Surg. 1996 Jan-Feb;5(1):62-8. doi: 10.1016/s1058-2746(96)80032-2.
Results Reference
background
PubMed Identifier
27079219
Citation
Uquillas CA, Capogna BM, Rossy WH, Mahure SA, Rokito AS. Postoperative pain control after arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2016 Jul;25(7):1204-13. doi: 10.1016/j.jse.2016.01.026. Epub 2016 Apr 11.
Results Reference
background
PubMed Identifier
22928433
Citation
Waterman B, Walker JJ, Swaims C, Shortt M, Todd MS, Machen SM, Owens BD. The efficacy of combined cryotherapy and compression compared with cryotherapy alone following anterior cruciate ligament reconstruction. J Knee Surg. 2012 May;25(2):155-60. doi: 10.1055/s-0031-1299650.
Results Reference
background
PubMed Identifier
32081634
Citation
Tashjian RZ, Shin J, Broschinsky K, Yeh CC, Martin B, Chalmers PN, Greis PE, Burks RT, Zhang Y. Minimal clinically important differences in the American Shoulder and Elbow Surgeons, Simple Shoulder Test, and visual analog scale pain scores after arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2020 Jul;29(7):1406-1411. doi: 10.1016/j.jse.2019.11.018. Epub 2020 Feb 17.
Results Reference
background
PubMed Identifier
11743529
Citation
Singh H, Osbahr DC, Holovacs TF, Cawley PW, Speer KP. The efficacy of continuous cryotherapy on the postoperative shoulder: a prospective, randomized investigation. J Shoulder Elbow Surg. 2001 Nov-Dec;10(6):522-5. doi: 10.1067/mse.2001.118415.
Results Reference
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Cryotherapy Following Rotator Cuff Repair Surgery

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