Combined Cryotherapy With Compression Versus Cryotherapy Alone After Orthopaedic Surgery

Not Applicable

Recruiting

• Conditions: Compression; Postoperative Pain Management; Cryotherapy Effect
• Interventions: Other: Control Cryotherapy Group; Device: Game Ready Cryotherapy with Compression Group

• Registration Number: NCT05011084
• Lead Sponsor: Walter Reed National Military Medical Center

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.

Study Timeline

• Study Start: 2020-11-02
• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-08-11
• Study First Posted: 2021-08-18
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-14
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 504

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Cryotherapy Group	Control Cryotherapy Group	Post-operative treatment will involve using the standard of care cryotherapy (i.e., traditional ice packs without compression).
Game Ready Cryotherapy with Compression Group	Game Ready Cryotherapy with Compression Group	Post-operative treatment will involve using a Game Ready ® unit

Primary Outcome Measures

Name	Time	Method
Change in the Defense and Veterans Pain Rating Scale (DVPRS) before and after each cryotherapy session	Post-operative days 1-14	Quick survey to assess pain level in the moment before and after each cryotherapy session.; The DVPRS consists of a basic traffic-light color code. Green represents mild pain with a scale ranging from 0-4; yellow represents moderate pain with a scale ranging from 5-6, and red represents severe pain with a scale ranging from 7-10. The DVPRS also includes an additional visual tool: facial expressions that correspond with each number. The faces range from a full happy face representing a pain level of zero to a grimacing face representing a pain level of 10.
Cryotherapy Device Usage	Post-operative days 1-14	Patients will maintain a Daily Therapy Log to document their usage of the assigned cryotherapy device.
Defense and Veterans Pain Rating Scale (DVPRS) right before bed time	Post-operative days 1-14	Quick survey to assess pain level in the moment at the time right before going to sleep.; The DVPRS consists of a basic traffic-light color code. Green represents mild pain with a scale ranging from 0-4; yellow represents moderate pain with a scale ranging from 5-6, and red represents severe pain with a scale ranging from 7-10. The DVPRS also includes an additional visual tool: facial expressions that correspond with each number. The faces range from a full happy face representing a pain level of zero to a grimacing face representing a pain level of 10.
Change in the Single Assessment Numeric Evaluation (SANE) from before surgery to after surgery	Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months	The SANE score is a validated patient reported outcome measure. It is a single question score that asks, "how would you rate your condition today as a percentage of normal (0% to 100% scale with 100% being normal)?" The SANE score is collected as standard of care.
Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety (ANX) from before surgery to after surgery	Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months	This patient reported outcome focuses on fear (e.g., worry, feelings of panic), anxious misery (e.g., dread), hyperarousal (e.g., tension, nervousness, restlessness), and somatic symptoms related to arousal (e.g., cardiovascular symptoms, dizziness)
Change in the Hip Disability and Osteoarthritis Outcome Score (HOOS) from before surgery to after surgery	Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months	The hip disability and osteoarthritis outcome score (HOOS) is a questionnaire intended to be used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process
Demographics Survey	Pre-operation (baseline)	Prior to undergoing their arthroscopy, participants will complete a brief Demographics survey, which asks relevant medical and service history and demographic questions including: sex, race/ethnicity, year of birth, marital status, military affiliation, branch of service, military rank, occupational specialty, and employment status.
Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) from before surgery to after surgery	Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months	This patient reported outcome measures the outcome of patients with musculoskeletal disorders by assessing physical function through a grading scale of activities of daily living
Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) from before surgery to after surgery	Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months	This patient reported outcome measures the extent to which pain hinders an individual's engagement with physical, mental, cognitive, emotional, recreational, and social activities
Defense and Veterans Pain Rating Scale (DVPRS) at wake up	Post-operative days 1-14	Quick survey to assess pain level in the moment at the time of wake up.; The DVPRS consists of a basic traffic-light color code. Green represents mild pain with a scale ranging from 0-4; yellow represents moderate pain with a scale ranging from 5-6, and red represents severe pain with a scale ranging from 7-10. The DVPRS also includes an additional visual tool: facial expressions that correspond with each number. The faces range from a full happy face representing a pain level of zero to a grimacing face representing a pain level of 10.
Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Depression (DEP) from before surgery to after surgery	Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months	This patient reported outcome focuses on affective and cognitive manifestations of depression rather than somatic symptoms such as appetite, fatigue and sleep
Medication Consumption	Post-operative days 1-14	Patients will maintain a daily Medication Log to record their consumption of pain medications.
Change in the Defense and Veterans Pain Rating Scale (DVPRS) from before surgery to after surgery	Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months	The DVPRS consists of a basic traffic-light color code. Green represents mild pain with a scale ranging from 0-4; yellow represents moderate pain with a scale ranging from 5-6, and red represents severe pain with a scale ranging from 7-10. The DVPRS also includes an additional visual tool: facial expressions that correspond with each number. The faces range from a full happy face representing a pain level of zero to a grimacing face representing a pain level of 10.; Four supplemental questions are included in the DVPRS to help identify how pain affects an individual's lifestyle. These questions also include a numerical scale that ranges from zero to 10 for each question. The four supplemental questions ask about pain pertaining to: daily activity during the past 24 hours, mood during the past 24 hours, sleep during the past 24 hours, stress during the past 24 hours
Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Interference (SI) from before surgery to after surgery	Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months	This patient reported outcome measures self-reported alertness, sleepiness, tiredness, and functional impairments associated with sleep problems during waking hours within the past seven days
Change in the American Shoulder and Elbow Surgeons Standardized Shoulder Form (ASES) from before surgery to after surgery	Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months	The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points
Change in the International Knee Documentation Committee (IKDC) from before surgery to after surgery	Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months	The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee

Trial Locations

Locations (1)

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States