Cryotherapy Following Rotator Cuff Repair Surgery

NCT04705376 | Withdrawn DMC FDA Device

• 1 other identifier: STUDY20200700
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears

Keywords

Arthroscopy; Opioid Use

Outcome Measures

Primary Outcomes (6)

• Pain Visual Analog Scale

  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

  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

  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

  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)

  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)

  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 Outcomes (2)

• Adverse reactions from cryotherapy devices

  2 weeks post-operatively

• Adverse reactions from cryotherapy devices

  6 weeks post-operatively

Study Arms (2)

Breg Polarcare

ACTIVE COMPARATOR

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; Device: Thermazone

Thermazone

EXPERIMENTAL

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; Device: Thermazone

Interventions

Breg Polarcare DEVICE

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).

Breg Polarcare; Thermazone

Thermazone DEVICE

ThermaZone is a compact device that uses thermoelectric technology to provide heating and cooling therapy without the use of ice.

Breg Polarcare; Thermazone

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing primary arthroscopic rotator cuff repair.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Innovative Medical Equipment, LLC: collaborator
• Ohio Third Frontier: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (10)

• 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.

  PMID: 24562697 BACKGROUND

• 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.

  PMID: 25825138 BACKGROUND

• 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.

  PMID: 15915833 BACKGROUND

• 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.

  PMID: 26684664 BACKGROUND

• 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.

  PMID: 27462522 BACKGROUND

• 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.

  PMID: 8919444 BACKGROUND

• 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.

  PMID: 27079219 BACKGROUND

• 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.

  PMID: 22928433 BACKGROUND

• 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.

  PMID: 32081634 BACKGROUND

• 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.

  PMID: 11743529 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Shoulder and Elbow Surgery, UH Cleveland Medical Center Program Director, Orthopaedic Surgery, UH Cleveland Medical Center Associate Professor, CWRU School of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 12, 2021
• Study Start: January 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: November 1, 2021
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)