Cryotherapy Effect Clinical Trial
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04019392 -
Rate of Tissue Temperature Reduction Between Wetted Ice and Game Ready
|
N/A | |
Not yet recruiting |
NCT05255146 -
Cryoanalgesia and Post-thoracotomy Pain in Minimally Invasive Cardiothoracic Surgery
|
N/A | |
Completed |
NCT02497495 -
Behaviour After Exercise of Biological, Clinical and Metabolic Variables as From Different Temperatures and Times of Immersion Cold Water Application
|
N/A | |
Completed |
NCT02499640 -
The Effects of Cold Water Immersion With Different Dosages (Duration and Temperature Variations) on Heart Rate Variability Post-exercise Recovery
|
N/A | |
Completed |
NCT03643835 -
Efficacy of an Investigational Thermal Rehab Machine on Body Cooling in Hyperthermic Individuals
|
N/A | |
Completed |
NCT04287153 -
Cryotherapy and Body Slimming
|
N/A | |
Recruiting |
NCT05600088 -
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With NSTEMI or Unstable Angina
|
N/A | |
Completed |
NCT04119297 -
Effects of Cold Application and Heparinoid on Periorbital Edema and Ecchymosis
|
N/A | |
Recruiting |
NCT05884099 -
Intercostal Cryoanalgesia for Chronic Pain After VATS Lung Resection
|
N/A | |
Recruiting |
NCT05896150 -
Intercostal Cryoanalgesia for Acute Pain After VATS Lung Resection
|
N/A | |
Completed |
NCT03973385 -
Evaluation of Efficacy of Cryotherapy for Skin Anesthesia During Arterial Puncture
|
N/A | |
Recruiting |
NCT05555602 -
Observation of the Comfort and Efficacy of CO2 Laser Combined With Cryo 6 for Burn or Linear Scars.
|
N/A | |
Completed |
NCT04190264 -
Body Cooling in Hyperthermic Males and Females
|
N/A | |
Completed |
NCT04781244 -
Cost-effectiveness of EndWarts® FREEZE - an Alternative Home Cryotherapy Device for Wart Treatment
|
N/A | |
Completed |
NCT03911830 -
Aerobic Exercise Program Followed by Cold Water Immersion: Effects on Arthritis Patients Arterial Stiffness
|
N/A | |
Recruiting |
NCT06223490 -
Effect of Cryolipolysis on Insulin Resistance
|
N/A | |
Recruiting |
NCT04164511 -
Does Ice Cream Help With Post-tonsillectomy Pain
|
||
Completed |
NCT05355584 -
Acute Effects of Cryotherapy Duration in Healthy Individuals
|
N/A | |
Completed |
NCT05476445 -
Effect of Cryotherapy and LLLT on Postoperative Pain After Root Canal Treatment
|
N/A | |
Completed |
NCT03151031 -
Effect on Dynamic Postural Stability After Application of Cryotherapy to the Knee Joint
|
N/A |