Clinical trial NCT05011084: Combined Cryotherapy With Compression Versus Cryotherapy Alone After Orthopaedic Surgery
Official title: Randomized Control Trial of Combined Cryotherapy With Compression Versus Cryotherapy Alone After Orthopaedic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cryotherapy Effect
Compression
Postoperative Pain Management
Keywords: Postoperative Pain Management
Opioid Epidemic
Cryotherapy
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
First posted: 2021-08-18
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cryotherapy has been used to enhance recovery after orthopaedic surgery. Many devices are available but few can guarantee a temperature regulation during a prolonged time and therefore have been criticized. The arrival of new advanced cryotherapy devices made it possible to test the effect of prolonged cooling on rehabilitation after arthroscopic orthopaedic procedures.

Detailed description: Opioids are most commonly administered for the treatment of pain and are among the most prescribed drugs in the United States (US). Between 2003 and 2011, opioid prescriptions increased from 149 million to 238 million \[3,5,7,11\]. In 2004, while constituting only 4.5% of the world's population, the US consumed 99% of the global supply of hydrocodone \[3,11\]. These trends resulted in the Centers for Disease Control and Prevention recognizing opioid abuse as an epidemic \[2,11\].

Pain management after orthopaedic arthroscopic procedures is mandatory regardless of the surgical technique. Cold therapy (cryotherapy) has been widely used for many years in the treatment of postoperative pain management in orthopaedic surgery and most studies have reported better pain scores and reduced drug consumptions \[1,6,8\]. Cryotherapy involves applying a cold device to the skin surrounding the injured soft tissues to reduce the intraarticular temperature. It reduces local blood flow by vasoconstriction, which in turn also reduces local inflammatory reaction, swelling, and heat experience. It also decreases the conduction of nerve signals potentially reducing pain transmission \[14,15\]. Several cryotherapy options are available: first generation cold therapy like crushed ice in a plastic bag, cold or gel packs; second-generation cold therapy with circulating ice water with or without compression; and third-generation advanced computer-assisted devices with continuous controlled cold therapy.

Cryotherapy is the standard of care in some countries and rarely is used in others \[17\]. Conflicting evidence regarding the value of this treatment from randomized trials may contribute to that practice disparity \[16\]. Raynor et al \[8\] showed that cryotherapy has a statistically significant benefit in postoperative pain control, while no improvement in postoperative range of motion or drainage was found. Cryotherapy with compression units are inexpensive, easy to use, have a high level of patient satisfaction, and are rarely associated with adverse events. Raynor et al \[8\] concluded cryotherapy may be justified in the postoperative management of knee surgery.

Postoperative cryotherapy with compression was proposed as a method of reducing pain and the inflammatory response in the early postoperative period after orthopaedic arthroscopic procedures. Previous study results are equivocal. Kraeutler et al \[12\] reported that there does not appear to be a significant benefit to use of cold compression over standard ice wraps in patients undergoing shoulder arthroscopy for rotator cuff repair or subacromial decompression. While Alfuth et al \[13\] concluded no recommendations can be made regarding the question whether cold compression therapy or cold therapy should be preferred immediately after arthroscopic surgery of the shoulder. Our goal is to analyze the analgesic efficacy of cryotherapy after shoulder, knee, and hip arthroscopic procedures using the Game Ready © which is a second generation cryotherapy with compression system. The investigators hypothesize this may decrease postoperative opioid usage as well as be more cost effective when compared to first generation cryotherapy (ice packs without compression) for medical healthcare systems.

Eligibility criteria: Inclusion Criteria:

* Adult (18 years of age or older)
* Eligible for DEERS (Defense Enrollment Eligibility Reporting System - A system that enables uniformed service members \& family members to receive health care through TRICARE)
* Fluent in speaking, reading, and understanding English
* Scheduled to receive one of the following procedures: Knee arthroscopy, Shoulder arthroscopy, or Hip arthroscopy

Exclusion Criteria:

* Unable to understand and/or provide written informed consent
* Presence of concurrent additional injuries (e.g., both a knee and hip injury). Participants can only have one injury

Primary outcomes:
measure: Change in the Defense and Veterans Pain Rating Scale (DVPRS) before and after each cryotherapy session
timeFrame: Post-operative days 1-14
measure: Defense and Veterans Pain Rating Scale (DVPRS) at wake up
timeFrame: Post-operative days 1-14
measure: Defense and Veterans Pain Rating Scale (DVPRS) right before bed time
timeFrame: Post-operative days 1-14
measure: Cryotherapy Device Usage
timeFrame: Post-operative days 1-14
measure: Medication Consumption
timeFrame: Post-operative days 1-14
measure: Demographics Survey
timeFrame: Pre-operation (baseline)
measure: Change in the Single Assessment Numeric Evaluation (SANE) from before surgery to after surgery
timeFrame: Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months
measure: Change in the Defense and Veterans Pain Rating Scale (DVPRS) from before surgery to after surgery
timeFrame: Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months
measure: Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) from before surgery to after surgery
timeFrame: Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months
measure: Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) from before surgery to after surgery
timeFrame: Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months
measure: Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Depression (DEP) from before surgery to after surgery
timeFrame: Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months
measure: Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety (ANX) from before surgery to after surgery
timeFrame: Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months
measure: Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Interference (SI) from before surgery to after surgery
timeFrame: Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months
measure: Change in the American Shoulder and Elbow Surgeons Standardized Shoulder Form (ASES) from before surgery to after surgery
timeFrame: Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months
measure: Change in the International Knee Documentation Committee (IKDC) from before surgery to after surgery
timeFrame: Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months
measure: Change in the Hip Disability and Osteoarthritis Outcome Score (HOOS) from before surgery to after surgery
timeFrame: Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Walter Reed National Military Medical Center
name: Ashley B Anderson, MD
role: PRINCIPAL_INVESTIGATOR
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