Three patients refused to participate in the study. Enrollment was performed until 40 patients were enrolled in the study (20 patients in each group). Randomization was performed with a random number generator, and patients were assigned to a treatment group following consent to participate. Complete follow-up was available for all patients. There were 13 (65%) male patients in the CC group. The average age of the CC group at the time of surgery was 68.7 years (range). There were 11 male patients in the ICE group. The average age of the ICE group at the time of surgery was 73.2 years (range). The dominant extremity was involved in 9 (45%) patients in the CC group and in 11 patients (55%) in the ICE group. Surgical case specifics are summarized in Table 1.
Table 1. Summary of Surgical Cases
CC group (n = 20) | ICE group (n = 20) | |
Primary TSA | 7 (35%) | 9 (45%) |
Primary RSA | 12 (60%) | 9 (45%) |
Revision arthroplasty | 1 (5%) | 2 (10%) |
Abbreviations: CC, continuous cryotherapy; ICE, plain ice; RSA, reverse shoulder arthroplasty; TSA, total shoulder arthroplasty.
All surgeries were performed by Dr. Denard. All patients received a single-shot interscalene nerve block prior to the procedure. A deltopectoral approach was utilized, and the subscapularis was managed with the peel technique.9 All patients were admitted to the hospital following surgery. Standard postoperative pain control consisted of as-needed intravenous morphine (1-2 mg every 2 hours, as needed) or an oral narcotic (hydrocodone/acetaminophen 5/325mg, 1-2 every 4 hours, as needed) which was also provided at discharge. However, total narcotic usage was recorded in morphine equivalents to account for substitutions. No non-steroidal anti-inflammatory drugs were allowed until 3 months postoperatively.
The CC group received treatment from a commercially available cryotherapy unit (Polar Care; Breg). All patients received instructions by a medical professional on how to use the unit. The unit was applied immediately postoperatively and set at a temperature of 45°F to 55°F. Patients were instructed to use the unit continuously during postoperative days 0 to 3. This cryotherapy was administered by a nurse while in the hospital but was left to the responsibility of the patient upon discharge. Patients were instructed to use the unit as needed for pain control during the day and continuously while asleep from days 4 to14.
The ICE group used standard ice packs postoperatively. The patients were instructed to apply an ice pack for 20 min every 2 hours while awake during days 0 to 3. This therapy was administered by a nurse while in the hospital but left to the responsibility of the patient upon discharge. Patients were instructed to use ice packs as needed for pain control during the day at a maximum of 20 minutes per hour on postoperative days 4 to 14. Compliance by both groups was monitored using a patient survey after hospital discharge. The number of hours that patients used either the CC or ICE per 24-hour period was recorded at 24 hours, 3 days, 7 days, and 14 days. The nursing staff recorded the number of hours of use of either cold modality for each patient prior to hospital discharge. The average length of stay as an inpatient was 1.2 days for the CC group and 1.3 days for the ICE group.
Visual analog scales (VAS) for pain, satisfaction with the cold therapy, and quality of sleep were recorded preoperatively and postoperatively at 24 hours, 3 days, 7 days, and 14 days following surgery.
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