Rotator Cuff Tear
Conditions
Keywords
cold compression, postoperative pain, shoulder surgery, arthroscopy
Brief 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 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.
Interventions
DEVICEBreg Polar Care Wave Cold Compression Device
cold compression sleeve
Sponsors
University of Nevada, Reno
Taos Orthopedic Institute
Mammoth Orthopedic Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* • 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
Exclusion criteria
* • 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative opioid consumption using milligram morphine equivalents | 6 weeks | opioid consumption conversion of opioid consumption to MMEQ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS | 6 weeks | VAS pain scores |
| sleep quality | 6 weeks | pittsburgh sleep quality index |
Countries
United States
Contacts
STUDY_DIRECTORDan Guttmann, MD
Taos Orthopedic Institute
Outcome results
None listed