Rotator Cuff TearCCROUTNCT07455474
Clinical Research Study of the Benefits of BREG Polar Care Wave to Reduce Opioid Use by Patients Having Undergone Arthroscopic Rotator Cuff Repair Shoulder Surgery
A study testing Breg Polar Care Wave Cold Compression Device in people with Rotator Cuff Tear, run by University of Nevada, Reno at 2 sites in United States.
Trial summary
The goal of this clinical trial is to compare effect of cold compression to standard of care in patients undergoing rotator cuff repair. The main question[s] it aims to answer are: whether opioid use is decreased in the experimental cold compression group whether patient reported outcomes and pain scores are reduced… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Breg Polar Care Wave Cold Compression Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2023to 3 Mar 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients scheduled for arthroscopic rotator cuff surgical repair between the dates of July 17, 2023, and November 30, 2023
- Adult males and females ages 18 to 70
- No prior experience using the Breg Polar Care Wave device
- No adverse underlying medical conditions or comorbidities that may enhance pain, require drugs that interact with opioids, or otherwise confound the results
- Ownership of or daily access to a smart phone or internet-connected computer
Who cannot join
- • Patients scheduled for arthroscopic rotator cuff surgical repair outside the dates of July 17, 2023, and November 30, 2023
- Adults aged 71 and above
- Children below the age of 18
- Other medical conditions or concomitant medication use that are known to negatively impact the outcome of rotator cuff repair
- o These include diabetes, current smoker, workers compensation claim, history of prior surgery on same shoulder, chronic pain, and pre-operative opioid use. Exclusion of this population is necessary in order to limit the introduction of confounding factors that could affect opioid usage independent of the Polar Care Wave.
- Concurrent participation in other studies
- Prior experience using the Breg Polar Care Wave device
- Do not have daily access to an internet-connected device to provide study data
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mammoth Hospital
Mammoth Lakes, California, 93546
Taos Orthopedic Institute
Taos, New Mexico, 87571
About this study
Official title: Clinical Research Study of the Benefits of Cold Compression to Reduce Opioid Use by Patients Having Undergone Arthroscopic Rotator Cuff Repair Shoulder Surgery
The goal of this clinical trial is to compare effect of cold compression to standard of care in patients undergoing rotator cuff repair. The main question[s] it aims to answer are:
- whether opioid use is decreased in the experimental cold compression group
- whether patient reported outcomes and pain scores are reduced in the experimental cold compression group Participants will be randomized to standard postoperative care versus standard postoperative care with use of cold compression therapy Researchers will compare control and experimental cold compression groups to see if there are differences between groups
Read the detailed description
The primary objective of this study is to determine whether patients, who have undergone arthroscopic rotator cuff repair surgery and who use the Polar Care Wave, use fewer opioids for a shorter duration post-operatively relative to the standard of care. Therefore, all patients enrolled in the study will be prescribed opioids for pain control after surgery. These medications will be taken at the discretion of each patient but not more than the dose recommended by the physician.
The secondary objectives of this study are to determine whether patients who have undergone arthroscopic rotator cuff repair surgery and who use the Polar Care Wave:
- experience lower pain during the 30-day post-operative period relative to the standard of care.
- experience improved quality of sleep during the 30-day post-operative period relative to the standard of care assessed via the Pittsburg Sleep Quality Index (Appendix B).
- experience improved post-surgical physical therapy outcomes measured by range of motion (ROM) relative to the standard of care.
We hypothesize that patients using the Polar Care Wave will report less frequent use and lower doses of opioid pain medications, a lower degree of pain, and improved sleep quality during the 30-day post-operative recovery period compared to patients recovering with the current standard of care (the control). We also hypothesize that these patients will have better ROM measures at 6 weeks post-operative compared to the control.
- Conditions
- Rotator Cuff Tear
- Being tested
- Breg Polar Care Wave Cold Compression Device
- Keywords
- cold compression, postoperative pain, shoulder surgery, arthroscopy
- Medical subject headings
- Rotator Cuff Injuries, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breg Polar Care Wave Cold Compression DeviceDevice
cold compression sleeve
| Study group | Role | What they receive |
|---|---|---|
| cold compression | Experimental | These patients will receive a cold compression device in addition to standard postoperative care Receives: Device: Breg Polar Care Wave Cold Compression Device |
| control | No intervention | This group will have standard postoperative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative opioid consumption using milligram morphine equivalents
opioid consumption conversion of opioid consumption to MMEQ
Measured: 6 weeks
Secondary outcomes (2)
VAS
VAS pain scores
Measured: 6 weeks
sleep quality
pittsburgh sleep quality index
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Oct 2023
- Primary completion1 Mar 2025
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will enroll a total of at least 60 subjects. The sample size is based on a matter of practical convenience, i.e., based on the number of arthroscopic rotator cuff repair procedures reasonably expected to be performed on eligible patients during the study's time period at the clinical sites. We carried out power analysis using our anticipated sample size of 60 subjects for a two-sided t-test with a 95% confidence interval in G\*Power. For a small (0.2), medium (0.5), or large effect size (d=0.8), the achieved power would be 0.12, 0.48, or 0.86, respectively. Therefore, we anticipate good power for a large effect size and plan to carry out post hoc power analysis for insignificant results. An equal number of subjects are required for the control group and test group (described below); thus, each group of the study will be comprised of at least 30 subjects. This will be a multi-site study. As such, all study participants will be enrolled at one of the two clinical sites.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Reno
- Sponsor type
- University, hospital or other
- Collaborators
- Taos Orthopedic Institute, Mammoth Orthopedic Institute
- Responsible party
- Principal investigator, Brian Gilmer, MD, University of Nevada, Reno
- Investigators
- Dan Guttmann, MD, Study director, Taos Orthopedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455474
- Sponsor's protocol ID
- 2045754-2
- Acronym
- CCROUT
- Status last verified
- Mar 2025
- First submitted
- 7 Sep 2023
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: only as necessary for piublication and verification of results
Publications
8 Reeves, B. Using Cold Therapy To Improve Patient Satisfaction and Reduce Opioid Use Post Surgery, 2018.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research Study of the Benefits of Cold Compression to Reduce Opioid Use by Patients Having Undergone Arthroscopic Rotator Cuff Repair Shoulder Surgery
- ClinicalTrials.gov ID
- NCT07455474
- Acronym / sponsor ID
- CCROUT / 2045754-2
- Conditions
- Rotator Cuff Tear
- Keywords
- cold compression, postoperative pain, shoulder surgery, arthroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Nevada, RenoUniversity, hospital or other
- Collaborators
- Taos Orthopedic Institute, Mammoth Orthopedic Institute
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 6 Mar 2026 (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 goal of this clinical trial is to compare effect of cold compression to standard of care in patients undergoing rotator cuff repair. The main question[s] it aims to answer are:
- whether opioid use is decreased in the experimental cold compression group
- whether patient reported outcomes and pain scores are reduced in the experimental cold compression group Participants will be randomized to standard postoperative care versus standard postoperative care with use of cold compression therapy Researchers will compare control and experimental cold compression groups to see if there are differences between groups
Detailed description
The primary objective of this study is to determine whether patients, who have undergone arthroscopic rotator cuff repair surgery and who use the Polar Care Wave, use fewer opioids for a shorter duration post-operatively relative to the standard of care. Therefore, all patients enrolled in the study will be prescribed opioids for pain control after surgery. These medications will be taken at the discretion of each patient but not more than the dose recommended by the physician.
The secondary objectives of this study are to determine whether patients who have undergone arthroscopic rotator cuff repair surgery and who use the Polar Care Wave:
- experience lower pain during the 30-day post-operative period relative to the standard of care.
- experience improved quality of sleep during the 30-day post-operative period relative to the standard of care assessed via the Pittsburg Sleep Quality Index (Appendix B).
- experience improved post-surgical physical therapy outcomes measured by range of motion (ROM) relative to the standard of care.
We hypothesize that patients using the Polar Care Wave will report less frequent use and lower doses of opioid pain medications, a lower degree of pain, and improved sleep quality during the 30-day post-operative recovery period compared to patients recovering with the current standard of care (the control). We also hypothesize that these patients will have better ROM measures at 6 weeks post-operative compared to the control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will enroll a total of at least 60 subjects. The sample size is based on a matter of practical convenience, i.e., based on the number of arthroscopic rotator cuff repair procedures reasonably expected to be performed on eligible patients during the study's time period at the clinical sites. We carried out power analysis using our anticipated sample size of 60 subjects for a two-sided t-test with a 95% confidence interval in G*Power. For a small (0.2), medium (0.5), or large effect size (d=0.8), the achieved power would be 0.12, 0.48, or 0.86, respectively. Therefore, we anticipate good power for a large effect size and plan to carry out post hoc power analysis for insignificant results. An equal number of subjects are required for the control group and test group (described below); thus, each group of the study will be comprised of at least 30 subjects. This will be a multi-site study. As such, all study participants will be enrolled at one of the two clinical sites.
| Arm | Type | Receives |
|---|---|---|
| cold compression | Experimental | Device: Breg Polar Care Wave Cold Compression DeviceThese patients will receive a cold compression device in addition to standard postoperative care |
| control | No intervention | –This group will have standard postoperative care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Patients scheduled for arthroscopic rotator cuff surgical repair between the dates of July 17, 2023, and November 30, 2023
Key exclusion criteria (8 listed)
- • Patients scheduled for arthroscopic rotator cuff surgical repair outside the dates of July 17, 2023, and November 30, 2023
- o These include diabetes, current smoker, workers compensation claim, history of prior surgery on same shoulder, chronic pain, and pre-operative opioid use. Exclusion of this population is necessary in order to limit the introduction of confounding factors that could affect opioid usage independent of the Polar Care Wave.
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 Polar Care Wave Cold Compression Devicecold compression sleeve | Device | cold compression |
Primary outcome
postoperative opioid consumption using milligram morphine equivalents
Time frame: 6 weeks
opioid consumption conversion of opioid consumption to MMEQ
2 secondary outcomes
VAS
Time frame: 6 weeks
sleep quality
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Background8 Reeves, B. Using Cold Therapy To Improve Patient Satisfaction and Reduce Opioid Use Post Surgery, 2018.
- Individual participant dataSharing planned: Undecided. only as necessary for piublication and verification of results
Related trials for Rotator Cuff Tear
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruiting
Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
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.
Dan Guttmann, MD study director
Taos Orthopedic Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breg Polar Care Wave Cold Compression Device in people with Rotator Cuff Tear, run by University of Nevada, Reno at 2 sites 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
postoperative opioid consumption using milligram morphine equivalents (time frame: 6 weeks). 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 NCT07455474, which also lists 1 linked publication.
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 6 Mar 2026.