Combined Cryotherapy With Compression Versus Cryotherapy Alone After Orthopaedic Surgery

NCT05011084 | Active Not Recruiting FDA Device

• 1 other identifier: WRNMMC-2020-0310
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

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.

Conditions

Cryotherapy Effect; Compression; Postoperative Pain Management

Keywords

Postoperative Pain Management; Opioid Epidemic; Cryotherapy

Outcome Measures

Primary Outcomes (16)

• Change in the Defense and Veterans Pain Rating Scale (DVPRS) before and after each cryotherapy session

  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.

  Post-operative days 1-14

• Defense and Veterans Pain Rating Scale (DVPRS) at wake up

  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.

  Post-operative days 1-14

• Defense and Veterans Pain Rating Scale (DVPRS) right before bed time

  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.

  Post-operative days 1-14

• Cryotherapy Device Usage

  Patients will maintain a Daily Therapy Log to document their usage of the assigned cryotherapy device.

  Post-operative days 1-14

• Medication Consumption

  Patients will maintain a daily Medication Log to record their consumption of pain medications.

  Post-operative days 1-14

• Demographics Survey

  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.

  Pre-operation (baseline)

• Change in the Single Assessment Numeric Evaluation (SANE) from before surgery to after surgery

  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.

  Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months

• Change in the Defense and Veterans Pain Rating Scale (DVPRS) from before surgery to after surgery

  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

  Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months

• Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) from before surgery to after surgery

  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

  Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months

• Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) from before surgery to after surgery

  This patient reported outcome measures the extent to which pain hinders an individual's engagement with physical, mental, cognitive, emotional, recreational, and social activities

  Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months

• Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Depression (DEP) from before surgery to after surgery

  This patient reported outcome focuses on affective and cognitive manifestations of depression rather than somatic symptoms such as appetite, fatigue and sleep

  Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months

• Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety (ANX) from before surgery to after surgery

  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)

  Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months

• Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Interference (SI) from before surgery to after surgery

  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

  Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months

• Change in the American Shoulder and Elbow Surgeons Standardized Shoulder Form (ASES) from before surgery to after surgery

  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

  Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months

• Change in the International Knee Documentation Committee (IKDC) from before surgery to after surgery

  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

  Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months

• Change in the Hip Disability and Osteoarthritis Outcome Score (HOOS) from before surgery to after surgery

  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

  Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months

Study Arms (2)

Game Ready Cryotherapy with Compression Group

EXPERIMENTAL

Post-operative treatment will involve using a Game Ready ® unit

Device: Game Ready Cryotherapy with Compression Group

Control Cryotherapy Group

ACTIVE COMPARATOR

Post-operative treatment will involve using the standard of care cryotherapy (i.e., traditional ice packs without compression).

Other: Control Cryotherapy Group

Interventions

Game Ready Cryotherapy with Compression Group DEVICE

Instead of using the traditional ice-pack cryotherapy (without compression), patients randomized into this group will use the Game Ready device, which uses cryotherapy with compression, during their post-operative treatment care.

Game Ready Cryotherapy with Compression Group

Control Cryotherapy Group OTHER

Patients randomized to the control group will use the standard of care, which is using traditional cryotherapy (i.e., an ice pack without compression)

Control Cryotherapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

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Study Officials

• Ashley B Bozzay, MD

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 18, 2021
• Study Start: November 2, 2020
• Primary Completion (Estimated): July 28, 2026
• Study Completion (Estimated): July 28, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)