Cryotherapy EffectNCT05011084
Combined Cryotherapy With Compression Versus Cryotherapy Alone After Orthopaedic Surgery
A study testing Game Ready Cryotherapy with Compression Group in people with Cryotherapy Effect and Compression, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cryotherapy Effect, Compression, Postoperative Pain Management
- What is being tested?
- Game Ready Cryotherapy with Compression Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2020to 4 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Official title: Randomized Control Trial of Combined Cryotherapy With Compression Versus Cryotherapy Alone After Orthopaedic Surgery
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.
Read the 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.
- Being tested
- Game Ready Cryotherapy with Compression Group, Control Cryotherapy Group
- Keywords
- Postoperative Pain Management, Opioid Epidemic, Cryotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game Ready Cryotherapy with Compression GroupDevice
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.
Control Cryotherapy GroupOther
Patients randomized to the control group will use the standard of care, which is using traditional cryotherapy (i.e., an ice pack without compression)
| Study group | Role | What they receive |
|---|---|---|
| Game Ready Cryotherapy with Compression Group | Experimental | Post-operative treatment will involve using a Game Ready ® unit Receives: 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). Receives: Other: Control Cryotherapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Post-operative days 1-14
Cryotherapy Device Usage
Patients will maintain a Daily Therapy Log to document their usage of the assigned cryotherapy device.
Measured: Post-operative days 1-14
Medication Consumption
Patients will maintain a daily Medication Log to record their consumption of pain medications.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start2 Nov 2020
- Primary completion4 Aug 2026
- Study completion4 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Cryotherapy EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Ashley Bozzay, MD, Walter Reed National Military Medical Center
- Investigators
- Ashley B Bozzay, MD, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011084
- Sponsor's protocol ID
- WRNMMC-2020-0310
- Status last verified
- Sep 2026
- First submitted
- 12 Jul 2021
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual level data will not be shared with anyone. Only aggregate results will be shared publicly.
Publications
Barber FA, McGuire DA, Click S. Continuous-flow cold therapy for outpatient anterior cruciate ligament reconstruction. Arthroscopy. 1998 Mar;14(2):130-5. doi: 10.1016/s0749-8063(98)70030-1.
PubMed 9531122Chakravarthy B, Shah S, Lotfipour S. Prescription drug monitoring programs and other interventions to combat prescription opioid abuse. West J Emerg Med. 2012 Nov;13(5):422-5. doi: 10.5811/westjem.2012.7.12936.
PubMed 23357954Kuehn BM. Opioid prescriptions soar: increase in legitimate use as well as abuse. JAMA. 2007 Jan 17;297(3):249-51. doi: 10.1001/jama.297.3.249. No abstract available.
PubMed 17227967Kumar K, Gulotta LV, Dines JS, Allen AA, Cheng J, Fields KG, YaDeau JT, Wu CL. Unused Opioid Pills After Outpatient Shoulder Surgeries Given Current Perioperative Prescribing Habits. Am J Sports Med. 2017 Mar;45(3):636-641. doi: 10.1177/0363546517693665. Epub 2017 Feb 9.
PubMed 28182507Manchikanti L, Helm S 2nd, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV. Opioid epidemic in the United States. Pain Physician. 2012 Jul;15(3 Suppl):ES9-38.
PubMed 22786464Morsi E. Continuous-flow cold therapy after total knee arthroplasty. J Arthroplasty. 2002 Sep;17(6):718-22. doi: 10.1054/arth.2002.33562.
PubMed 12216025Nelson AD, Camilleri M. Chronic opioid induced constipation in patients with nonmalignant pain: challenges and opportunities. Ther Adv Gastroenterol. 2015 Jul;8(4):206-20. doi: 10.1177/1756283X15578608.
PubMed 26136838Raynor MC, Pietrobon R, Guller U, Higgins LD. Cryotherapy after ACL reconstruction: a meta-analysis. J Knee Surg. 2005 Apr;18(2):123-9. doi: 10.1055/s-0030-1248169.
PubMed 15915833Schoenfeld AJ, Belmont PJ Jr, Blucher JA, Jiang W, Chaudhary MA, Koehlmoos T, Kang JD, Haider AH. Sustained Preoperative Opioid Use Is a Predictor of Continued Use Following Spine Surgery. J Bone Joint Surg Am. 2018 Jun 6;100(11):914-921. doi: 10.2106/JBJS.17.00862.
PubMed 29870441Scully RE, Schoenfeld AJ, Jiang W, Lipsitz S, Chaudhary MA, Learn PA, Koehlmoos T, Haider AH, Nguyen LL. Defining Optimal Length of Opioid Pain Medication Prescription After Common Surgical Procedures. JAMA Surg. 2018 Jan 1;153(1):37-43. doi: 10.1001/jamasurg.2017.3132.
PubMed 28973092Syed UAM, Aleem AW, Wowkanech C, Weekes D, Freedman M, Tjoumakaris F, Abboud JA, Austin LS. Neer Award 2018: the effect of preoperative education on opioid consumption in patients undergoing arthroscopic rotator cuff repair: a prospective, randomized clinical trial. J Shoulder Elbow Surg. 2018 Jun;27(6):962-967. doi: 10.1016/j.jse.2018.02.039. Epub 2018 Mar 26.
PubMed 29599038Kraeutler MJ, Reynolds KA, Long C, McCarty EC. Compressive cryotherapy versus ice-a prospective, randomized study on postoperative pain in patients undergoing arthroscopic rotator cuff repair or subacromial decompression. J Shoulder Elbow Surg. 2015 Jun;24(6):854-9. doi: 10.1016/j.jse.2015.02.004. Epub 2015 Mar 29.
PubMed 25825138Alfuth M, Strietzel M, Vogler T, Rosenbaum D, Liem D. Cold versus cold compression therapy after shoulder arthroscopy: a prospective randomized clinical trial. Knee Surg Sports Traumatol Arthrosc. 2016 Jul;24(7):2209-15. doi: 10.1007/s00167-015-3534-7. Epub 2015 Feb 13.
PubMed 25677503Algafly AA, George KP. The effect of cryotherapy on nerve conduction velocity, pain threshold and pain tolerance. Br J Sports Med. 2007 Jun;41(6):365-9; discussion 369. doi: 10.1136/bjsm.2006.031237. Epub 2007 Jan 15.
PubMed 17224445Kullenberg B, Ylipaa S, Soderlund K, Resch S. Postoperative cryotherapy after total knee arthroplasty: a prospective study of 86 patients. J Arthroplasty. 2006 Dec;21(8):1175-9. doi: 10.1016/j.arth.2006.02.159.
PubMed 17162178
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Combined Cryotherapy With Compression Versus Cryotherapy Alone After Orthopaedic Surgery
- ClinicalTrials.gov ID
- NCT05011084
- Acronym / sponsor ID
- WRNMMC-2020-0310
- Keywords
- Postoperative Pain Management, Opioid Epidemic, Cryotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 4 Aug 2026 (actual)
- Study completion
- 4 Aug 2026 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Game Ready Cryotherapy with Compression Group | Experimental | Device: Game Ready Cryotherapy with Compression GroupPost-operative treatment will involve using a Game Ready ® unit |
| Control Cryotherapy Group | Active comparator | Other: Control Cryotherapy GroupPost-operative treatment will involve using the standard of care cryotherapy (i.e., traditional ice packs without compression). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Game Ready Cryotherapy with Compression GroupInstead 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. | Device | Game Ready Cryotherapy with Compression Group |
| Control Cryotherapy GroupPatients randomized to the control group will use the standard of care, which is using traditional cryotherapy (i.e., an ice pack without compression) | Other | Control Cryotherapy Group |
Primary outcome
Change in the Defense and Veterans Pain Rating Scale (DVPRS) before and after each cryotherapy session
Time frame: 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.
Defense and Veterans Pain Rating Scale (DVPRS) at wake up
Time frame: 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.
Defense and Veterans Pain Rating Scale (DVPRS) right before bed time
Time frame: 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.
Cryotherapy Device Usage
Time frame: Post-operative days 1-14
Patients will maintain a Daily Therapy Log to document their usage of the assigned cryotherapy device.
Medication Consumption
Time frame: Post-operative days 1-14
Patients will maintain a daily Medication Log to record their consumption of pain medications.
Demographics Survey
Time frame: 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 Single Assessment Numeric Evaluation (SANE) from before surgery to after surgery
Time frame: 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 Defense and Veterans Pain Rating Scale (DVPRS) from before surgery to after surgery
Time frame: 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) Physical Function (PF) from before surgery to after surgery
Time frame: 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
Time frame: 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
Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Depression (DEP) from before surgery to after surgery
Time frame: 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
Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety (ANX) from before surgery to after surgery
Time frame: 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 Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Interference (SI) from before surgery to after surgery
Time frame: 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
Time frame: 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
Time frame: 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
Change in the Hip Disability and Osteoarthritis Outcome Score (HOOS) from before surgery to after surgery
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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- Background: PubMed 23357954Chakravarthy B, Shah S, Lotfipour S. Prescription drug monitoring programs and other interventions to combat prescription opioid abuse. West J Emerg Med. 2012 Nov;13(5):422-5. doi: 10.5811/westjem.2012.7.12936.
- Background: PubMed 17227967Kuehn BM. Opioid prescriptions soar: increase in legitimate use as well as abuse. JAMA. 2007 Jan 17;297(3):249-51. doi: 10.1001/jama.297.3.249. No abstract available.
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- Background: PubMed 22786464Manchikanti L, Helm S 2nd, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV. Opioid epidemic in the United States. Pain Physician. 2012 Jul;15(3 Suppl):ES9-38.
- Background: PubMed 12216025Morsi E. Continuous-flow cold therapy after total knee arthroplasty. J Arthroplasty. 2002 Sep;17(6):718-22. doi: 10.1054/arth.2002.33562.
- Background: PubMed 26136838Nelson AD, Camilleri M. Chronic opioid induced constipation in patients with nonmalignant pain: challenges and opportunities. Ther Adv Gastroenterol. 2015 Jul;8(4):206-20. doi: 10.1177/1756283X15578608.
- Background: PubMed 15915833Raynor MC, Pietrobon R, Guller U, Higgins LD. Cryotherapy after ACL reconstruction: a meta-analysis. J Knee Surg. 2005 Apr;18(2):123-9. doi: 10.1055/s-0030-1248169.
- Background: PubMed 29870441Schoenfeld AJ, Belmont PJ Jr, Blucher JA, Jiang W, Chaudhary MA, Koehlmoos T, Kang JD, Haider AH. Sustained Preoperative Opioid Use Is a Predictor of Continued Use Following Spine Surgery. J Bone Joint Surg Am. 2018 Jun 6;100(11):914-921. doi: 10.2106/JBJS.17.00862.
- Background: PubMed 28973092Scully RE, Schoenfeld AJ, Jiang W, Lipsitz S, Chaudhary MA, Learn PA, Koehlmoos T, Haider AH, Nguyen LL. Defining Optimal Length of Opioid Pain Medication Prescription After Common Surgical Procedures. JAMA Surg. 2018 Jan 1;153(1):37-43. doi: 10.1001/jamasurg.2017.3132.
- Background: PubMed 29599038Syed UAM, Aleem AW, Wowkanech C, Weekes D, Freedman M, Tjoumakaris F, Abboud JA, Austin LS. Neer Award 2018: the effect of preoperative education on opioid consumption in patients undergoing arthroscopic rotator cuff repair: a prospective, randomized clinical trial. J Shoulder Elbow Surg. 2018 Jun;27(6):962-967. doi: 10.1016/j.jse.2018.02.039. Epub 2018 Mar 26.
- Background: PubMed 25825138Kraeutler MJ, Reynolds KA, Long C, McCarty EC. Compressive cryotherapy versus ice-a prospective, randomized study on postoperative pain in patients undergoing arthroscopic rotator cuff repair or subacromial decompression. J Shoulder Elbow Surg. 2015 Jun;24(6):854-9. doi: 10.1016/j.jse.2015.02.004. Epub 2015 Mar 29.
- Individual participant dataSharing planned: No. Individual level data will not be shared with anyone. Only aggregate results will be shared publicly.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley B Bozzay, MD principal investigator
Walter Reed National Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game Ready Cryotherapy with Compression Group in people with Cryotherapy Effect and Compression, run by Walter Reed National Military Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Defense and Veterans Pain Rating Scale (DVPRS) before and after each cryotherapy session (time frame: Post-operative days 1-14). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05011084, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.