Rotator Cuff TearsNCT04705376
Cryotherapy Following Rotator Cuff Repair Surgery
A study testing Breg Polarcare and Thermazone in people with Rotator Cuff Tears, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Breg Polarcare and Thermazone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary arthroscopic rotator cuff repair.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
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.
Read the 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.
- Conditions
- Rotator Cuff Tears
- Being tested
- Breg Polarcare, Thermazone
- Keywords
- Arthroscopy, Opioid Use
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breg PolarcareDevice
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).
ThermazoneDevice
ThermaZone is a compact device that uses thermoelectric technology to provide heating and cooling therapy without the use of ice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Breg Polarcare; Device: Thermazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Visual Analog Scale
Scale from 0 to 10; 0 represents no pain and 10 represents the most amount of pain.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks post-operatively
Secondary outcomes (2)
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.
Measured: 2 weeks post-operatively
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.
Measured: 6 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start1 Jan 2021
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Innovative Medical Equipment, LLC, Ohio Third Frontier
- Responsible party
- Principal investigator, Robert J. Gillespie, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705376
- Sponsor's protocol ID
- STUDY20200700
- Status last verified
- Apr 2022
- First submitted
- 8 Jan 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24562697Kraeutler 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.
PubMed 25825138Raynor 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.
PubMed 15915833Secrist 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.
PubMed 26684664Song 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.
PubMed 27462522Speer 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.
PubMed 8919444Uquillas 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.
PubMed 27079219Waterman 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.
PubMed 22928433Tashjian 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.
PubMed 32081634Singh 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.
PubMed 11743529
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryotherapy Following Rotator Cuff Repair Surgery
- ClinicalTrials.gov ID
- NCT04705376
- Acronym / sponsor ID
- STUDY20200700
- Conditions
- Rotator Cuff Tears
- Keywords
- Arthroscopy, Opioid Use
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Innovative Medical Equipment, LLC, Ohio Third Frontier
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Breg Polarcare | Active comparator | Device: Breg Polarcare, Device: ThermazonePatients 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. |
| Thermazone | Experimental | Device: Breg Polarcare, Device: ThermazonePatients 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing primary arthroscopic rotator cuff repair.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breg PolarcareThe 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 | Breg Polarcare, Thermazone |
| ThermazoneThermaZone is a compact device that uses thermoelectric technology to provide heating and cooling therapy without the use of ice. | Device | Breg Polarcare, Thermazone |
Primary outcome
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Adverse reactions from cryotherapy devices
Time frame: 2 weeks post-operatively
Adverse reactions from cryotherapy devices
Time frame: 6 weeks post-operatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Background: PubMed 24562697Khoshnevis 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.
- Background: PubMed 25825138Kraeutler 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.
- Background: PubMed 15915833Raynor 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.
- Background: PubMed 26684664Secrist 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.
- Background: PubMed 27462522Song 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.
- Background: PubMed 8919444Speer 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.
- Background: PubMed 27079219Uquillas 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.
- Background: PubMed 22928433Waterman 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.
- Background: PubMed 32081634Tashjian 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.
- Background: PubMed 11743529Singh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breg Polarcare and Thermazone in people with Rotator Cuff Tears, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Visual Analog Scale (time frame: 2 weeks post-operatively). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04705376, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.