Effects of Gaseous Cryotherapy on Knee ROM After TKA: A Feasibility Study

Effects of Hyperbaric Gaseous Cryotherapy on Knee Flexion Range of Motion in the First Two Days After Total Knee Arthroplasty: A Feasibility Randomized Controlled Trial

A pilot study was performed to investigate the feasibility of a large randomized controlled trial (RCT) to assess the effects of hyperbaric gaseous cryotherapy (HGC) on the change in knee flexion range of motion in the first two days after total knee arthroplasty.

Background: After total knee arthroplasty (TKA), patients can be discharged from hospital as early as two days after surgery. However, patients often do not achieve functional knee flexion range of motion (ROM) in the first postoperative days. Early application of hyperbaric gaseous cryotherapy (HGC) at the operated knee within an hour after surgery and the next postoperative days might increase ROM by reducing inflammation, edema and pain. However, it is unclear whether such early application of HGC is feasible. Moreover, there is no data to allow calculation of the sample size required to conduct a randomized controlled trial to compare the effects of HGC to those of conventional cryotherapy on the increase of knee flexion in the first two days after TKA. Objectives: To investigate the feasibility of applying HGC within an hour after TKA and twice a day the next postoperative days. To collect data on changes in knee flexion ROM in the first two postoperative days to calculate the sample size required for a large randomized controlled trial. To compare the effects of HGC to those of conventional cryotherapy on changes in knee flexion ROM in the first two postoperative days. Design: A prospective, single-blinded, randomized, controlled pilot trial. Setting: Orthopedic postoperative unit in an acute care hospital. Interventions: Patients were randomly allocated to either hyperbaric gaseous cryotherapy (intervention group) or the ice bag cryotherapy (control group). In each group, participants received the specific cryotherapy intervention at the operated knee within an hour after the surgery (day 0) and twice the next two postoperative days (day 1 and day 2). Outcome measures: Feasibility measures included the rate of eligible patients who were willing to participate, attrition, adherence to interventions and presence of adverse effects. Active and passive knee flexion range of motion (ROM) and knee pain intensity at rest were evaluated on postoperative days 1 and 2. Change in active and passive knee flexion ROM and in knee pain intensity at rest from postoperative day 1 to day 2 were assessed. Length of hospital stay was collected.

Conventional rehabilitation with ice bag cryotherapy. Application of a bag of crushed ice directly on the anterior aspect of the knee.

In the intervention group, participants received hyperbaric gaseous cryotherapy delivered with a Cryoton ™ device (Cryonic Médical, Salins-les-Bains, France) within an hour after the surgery and two times per day the next postoperative days. The tip of the nozzle was kept 10-15 cm above the dry skin as the gaseous CO2 was sprayed on three zones of 5 cm by 10 cm (medial, lateral and posterior, respectively) using a slow and regular sweeping movement for approximately 30 seconds after a skin temperature of 2°C is reached.

In the control group, participants received two 20-minute treatments of cryotherapy within an hour after the surgery and two times per day the next postoperative days. Cryotherapy was performed using an ice bag that was applied directly on the anterior aspect of the knee. The ice bag is a square latex bag of 30 cm by 30 cm filled with crushed ice and wrapped in a thin pillow case. The treatment assessor applied the intervention in a standardized manner by ensuring that the knee was fully extended while covering the surgical incision and both lateral and medial aspects of the knee with the iced bag.

The primary outcomes were changes in active and passive knee flexion ROM from postoperative day 1 to day 2. This outcome was calculated as the difference in active and passive ROM between day 2 and day 1

Active and passive knee flexion ROMs were measured with a long-arm (35 cm) goniometer featuring a 360º and two 180º scales, with 1º increments that read in opposite directions (Baseline 360° 14" Goniometer, Fabrication enterprises Inc., NY, USA). Knee ROMs were measured in sitting position because levels of agreement between observers are higher in sitting position than in supine position.

Scale from 0 to 10 cm on a ruler where 0 represented no pain and 10 represented the worst pain imaginable.

Change in pain from postoperative day 1 to day 2 measured by analysis of variation of the recorded pain between data of day2 and day 1 (Knee pain measured by visual analog scale)

Length of the stay in hospital ward was measured by the length(in days) of inpatient episode of care.

Inclusion Criteria: Planned unilateral TKA done at Verdun Hospital. Capacity to communicate in French or English. Exclusion Criteria: Complications during or after the surgery. Inability to perform the tests due to other diseases. Contraindications to cryotherapy such as Raynaud's disease, cryoglobulinemia, hemoglobinopathy, polyneuropathy associated with temperature sensitivity deficits or allergy to cold.

Abramson DI, Chu LS, Tuck S Jr, Lee SW, Richardson G, Levin M. Effect of tissue temperatures and blood flow on motor nerve conduction velocity. JAMA. 1966 Dec 5;198(10):1082-8. No abstract available.

Adie S, Kwan A, Naylor JM, Harris IA, Mittal R. Cryotherapy following total knee replacement. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD007911. doi: 10.1002/14651858.CD007911.pub2.

Adie S, Naylor JM, Harris IA. Cryotherapy after total knee arthroplasty a systematic review and meta-analysis of randomized controlled trials. J Arthroplasty. 2010 Aug;25(5):709-15. doi: 10.1016/j.arth.2009.07.010. Epub 2009 Sep 2.

Alcelik I, Sukeik M, Pollock R, Misra A, Shah P, Armstrong P, Dhebar MI. Comparison of the minimally invasive and standard medial parapatellar approaches for primary total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2012 Dec;20(12):2502-12. doi: 10.1007/s00167-012-1944-3. Epub 2012 Mar 15.

Ayalon O, Liu S, Flics S, Cahill J, Juliano K, Cornell CN. A multimodal clinical pathway can reduce length of stay after total knee arthroplasty. HSS J. 2011 Feb;7(1):9-15. doi: 10.1007/s11420-010-9164-1. Epub 2010 May 22.

Bade MJ, Kittelson JM, Kohrt WM, Stevens-Lapsley JE. Predicting functional performance and range of motion outcomes after total knee arthroplasty. Am J Phys Med Rehabil. 2014 Jul;93(7):579-85. doi: 10.1097/PHM.0000000000000065.

Bade MJ, Kohrt WM, Stevens-Lapsley JE. Outcomes before and after total knee arthroplasty compared to healthy adults. J Orthop Sports Phys Ther. 2010 Sep;40(9):559-67. doi: 10.2519/jospt.2010.3317.

Basso DM, Knapp L. Comparison of two continuous passive motion protocols for patients with total knee implants. Phys Ther. 1987 Mar;67(3):360-3. doi: 10.1093/ptj/67.3.360. Erratum In: Phys Ther 1987 Jun;67(6):979.

Belitsky RB, Odam SJ, Hubley-Kozey C. Evaluation of the effectiveness of wet ice, dry ice, and cryogenic packs in reducing skin temperature. Phys Ther. 1987 Jul;67(7):1080-4. doi: 10.1093/ptj/67.7.1080.

Bonutti PM, Mont MA, Kester MA. Minimally invasive total knee arthroplasty: a 10-feature evolutionary approach. Orthop Clin North Am. 2004 Apr;35(2):217-26. doi: 10.1016/j.ocl.2004.02.001.

Chatap G, De Sousa A, Giraud K, Vincent JP; Acute Pain in the Elderly Study Group. Pain in the elderly: Prospective study of hyperbaric CO2 cryotherapy (neurocryostimulation). Joint Bone Spine. 2007 Dec;74(6):617-21. doi: 10.1016/j.jbspin.2006.10.011. Epub 2007 Jul 19.

Cheng T, Liu T, Zhang G, Peng X, Zhang X. Does minimally invasive surgery improve short-term recovery in total knee arthroplasty? Clin Orthop Relat Res. 2010 Jun;468(6):1635-48. doi: 10.1007/s11999-010-1285-9. Epub 2010 Mar 13.

Chesterton LS, Foster NE, Ross L. Skin temperature response to cryotherapy. Arch Phys Med Rehabil. 2002 Apr;83(4):543-9. doi: 10.1053/apmr.2002.30926.

Chiu KY, Ng TP, Tang WM, Yau WP. Review article: knee flexion after total knee arthroplasty. J Orthop Surg (Hong Kong). 2002 Dec;10(2):194-202. doi: 10.1177/230949900201000215.

Ciolek JJ. Cryotherapy. Review of physiological effects and clinical application. Cleve Clin Q. 1985 Summer;52(2):193-201. doi: 10.3949/ccjm.52.2.193. No abstract available.

Corbett KL, Reichmann WM, Katz JN, Beagan C, Corsello P, Ghazinouri R, Dang B, Mikulinsky R, Losina E, Wright J. One-Day vs Two-Day Epidural Analgesia for Total Knee Arthroplasty (TKA): A Retrospective Cohort Study. Open Orthop J. 2010 Jan 19;4:31-8. doi: 10.2174/1874325001004010031.

Dayton MR, Bade MJ, Muratore T, Shulman BC, Kohrt WM, Stevens-Lapsley JE. Minimally invasive total knee arthroplasty: surgical implications for recovery. J Knee Surg. 2013 Jun;26(3):195-201. doi: 10.1055/s-0032-1327449. Epub 2012 Nov 12.

Demoulin C, Brouwers M, Darot S, Gillet P, Crielaard JM, Vanderthommen M. Comparison of gaseous cryotherapy with more traditional forms of cryotherapy following total knee arthroplasty. Ann Phys Rehabil Med. 2012 May;55(4):229-40. doi: 10.1016/j.rehab.2012.03.004. Epub 2012 Apr 5. English, French.

Ekenvall L, Lindblad LE, Norbeck O, Etzell BM. alpha-Adrenoceptors and cold-induced vasoconstriction in human finger skin. Am J Physiol. 1988 Nov;255(5 Pt 2):H1000-3. doi: 10.1152/ajpheart.1988.255.5.H1000.

Ernst E, Fialka V. Ice freezes pain? A review of the clinical effectiveness of analgesic cold therapy. J Pain Symptom Manage. 1994 Jan;9(1):56-9. doi: 10.1016/0885-3924(94)90150-3.

Fatoye FA, Palmer ST, Macmillan F, Rowe PJ, van der Linden ML. Repeatability of joint proprioception and muscle torque assessment in healthy children and in children diagnosed with hypermobility syndrome. Musculoskeletal Care. 2008 Jun;6(2):108-23. doi: 10.1002/msc.127.

Freedman RR, Sabharwal SC, Moten M, Migaly P. Local temperature modulates alpha 1- and alpha 2-adrenergic vasoconstriction in men. Am J Physiol. 1992 Oct;263(4 Pt 2):H1197-200. doi: 10.1152/ajpheart.1992.263.4.H1197.

Garstang SV, Stitik TP. Osteoarthritis: epidemiology, risk factors, and pathophysiology. Am J Phys Med Rehabil. 2006 Nov;85(11 Suppl):S2-11; quiz S12-4. doi: 10.1097/01.phm.0000245568.69434.1a. No abstract available.

Harris ED Jr, McCroskery PA. The influence of temperature and fibril stability on degradation of cartilage collagen by rheumatoid synovial collagenase. N Engl J Med. 1974 Jan 3;290(1):1-6. doi: 10.1056/NEJM197401032900101. No abstract available.

Ho SS, Coel MN, Kagawa R, Richardson AB. The effects of ice on blood flow and bone metabolism in knees. Am J Sports Med. 1994 Jul-Aug;22(4):537-40. doi: 10.1177/036354659402200417.

Husted H, Holm G, Jacobsen S. Predictors of length of stay and patient satisfaction after hip and knee replacement surgery: fast-track experience in 712 patients. Acta Orthop. 2008 Apr;79(2):168-73. doi: 10.1080/17453670710014941.

Insall J. A midline approach to the knee. J Bone Joint Surg Am. 1971 Dec;53(8):1584-6. No abstract available.

Kennedy DM, Stratford PW, Wessel J, Gollish JD, Penney D. Assessing stability and change of four performance measures: a longitudinal study evaluating outcome following total hip and knee arthroplasty. BMC Musculoskelet Disord. 2005 Jan 28;6:3. doi: 10.1186/1471-2474-6-3.

Kettelkamp DB, Johnson RJ, Smidt GL, Chao EY, Walker M. An electrogoniometric study of knee motion in normal gait. J Bone Joint Surg Am. 1970 Jun;52(4):775-90. No abstract available.

Kim J, Seo BS. How to calculate sample size and why. Clin Orthop Surg. 2013 Sep;5(3):235-42. doi: 10.4055/cios.2013.5.3.235. Epub 2013 Aug 20.

Knight KL, Londeree BR. Comparison of blood flow in the ankle of uninjured subjects during therapeutic applications of heat, cold, and exercise. Med Sci Sports Exerc. 1980 Spring;12(1):76-80. doi: 10.1249/00005768-198021000-00015.

Kurtz SM, Ong KL, Lau E, Widmer M, Maravic M, Gomez-Barrena E, de Pina Mde F, Manno V, Torre M, Walter WL, de Steiger R, Geesink RG, Peltola M, Roder C. International survey of primary and revision total knee replacement. Int Orthop. 2011 Dec;35(12):1783-9. doi: 10.1007/s00264-011-1235-5. Epub 2011 Mar 15.

Laubenthal KN, Smidt GL, Kettelkamp DB. A quantitative analysis of knee motion during activities of daily living. Phys Ther. 1972 Jan;52(1):34-43. doi: 10.1093/ptj/52.1.34. No abstract available.

Lenssen AF, Crijns YH, Waltje EM, van Steyn MJ, Geesink RJ, van den Brandt PA, de Bie RA. Efficiency of immediate postoperative inpatient physical therapy following total knee arthroplasty: an RCT. BMC Musculoskelet Disord. 2006 Aug 31;7:71. doi: 10.1186/1471-2474-7-71.

Lenssen AF, van Dam EM, Crijns YH, Verhey M, Geesink RJ, van den Brandt PA, de Bie RA. Reproducibility of goniometric measurement of the knee in the in-hospital phase following total knee arthroplasty. BMC Musculoskelet Disord. 2007 Aug 17;8:83. doi: 10.1186/1471-2474-8-83.

Lin YC, Davey RC, Cochrane T. Tests for physical function of the elderly with knee and hip osteoarthritis. Scand J Med Sci Sports. 2001 Oct;11(5):280-6. doi: 10.1034/j.1600-0838.2001.110505.x.

Markert SE. The use of cryotherapy after a total knee replacement: a literature review. Orthop Nurs. 2011 Jan-Feb;30(1):29-36. doi: 10.1097/NOR.0b013e318205749a.

Martin SS, Spindler KP, Tarter JW, Detwiler KB. Does cryotherapy affect intraarticular temperature after knee arthroscopy? Clin Orthop Relat Res. 2002 Jul;(400):184-9. doi: 10.1097/00003086-200207000-00023.

McKay C, Prapavessis H, Doherty T. The effect of a prehabilitation exercise program on quadriceps strength for patients undergoing total knee arthroplasty: a randomized controlled pilot study. PM R. 2012 Sep;4(9):647-56. doi: 10.1016/j.pmrj.2012.04.012. Epub 2012 Jun 13.

McLean DA. The use of cold and superficial heat in the treatment of soft tissue injuries. Br J Sports Med. 1989 Mar;23(1):53-4. doi: 10.1136/bjsm.23.1.53. No abstract available.

Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.

Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992.

Mourot L, Cluzeau C, Regnard J. Hyperbaric gaseous cryotherapy: effects on skin temperature and systemic vasoconstriction. Arch Phys Med Rehabil. 2007 Oct;88(10):1339-43. doi: 10.1016/j.apmr.2007.06.771.

Mourot L, Cluzeau C, Regnard J. [Physiological assessment of a gaseous cryotherapy device: thermal effects and changes in cardiovascular autonomic control]. Ann Readapt Med Phys. 2007 May;50(4):209-17. doi: 10.1016/j.annrmp.2007.01.005. Epub 2007 Jan 26. French.

Nutton RW, Wade FA, Coutts FJ, van der Linden ML. Short Term Recovery of Function following Total Knee Arthroplasty: A Randomised Study of the Medial Parapatellar and Midvastus Approaches. Arthritis. 2014;2014:173857. doi: 10.1155/2014/173857. Epub 2014 Oct 1.

Ohkoshi Y, Ohkoshi M, Nagasaki S, Ono A, Hashimoto T, Yamane S. The effect of cryotherapy on intraarticular temperature and postoperative care after anterior cruciate ligament reconstruction. Am J Sports Med. 1999 May-Jun;27(3):357-62. doi: 10.1177/03635465990270031601.

Oldmeadow LB, McBurney H, Robertson VJ. Hospital stay and discharge outcomes after knee arthroplasty: implications for physiotherapy practice. Aust J Physiother. 2002;48(2):117-21. doi: 10.1016/s0004-9514(14)60205-1.

Olson JE, Stravino VD. A review of cryotherapy. Phys Ther. 1972 Aug;52(8):840-53. doi: 10.1093/ptj/52.8.840. No abstract available.

Pavlov VA, Tracey KJ. The cholinergic anti-inflammatory pathway. Brain Behav Immun. 2005 Nov;19(6):493-9. doi: 10.1016/j.bbi.2005.03.015.

Raynor 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.

Remy C, Marret E, Bonnet F. Effects of acetaminophen on morphine side-effects and consumption after major surgery: meta-analysis of randomized controlled trials. Br J Anaesth. 2005 Apr;94(4):505-13. doi: 10.1093/bja/aei085. Epub 2005 Jan 28.

Salinas FV, Liu SS, Mulroy MF. The effect of single-injection femoral nerve block versus continuous femoral nerve block after total knee arthroplasty on hospital length of stay and long-term functional recovery within an established clinical pathway. Anesth Analg. 2006 Apr;102(4):1234-9. doi: 10.1213/01.ane.0000198675.20279.81.

Scarcella JB, Cohn BT. The effect of cold therapy on the postoperative course of total hip and knee arthroplasty patients. Am J Orthop (Belle Mead NJ). 1995 Nov;24(11):847-52.

Singelyn FJ, Ferrant T, Malisse MF, Joris D. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous femoral nerve sheath block on rehabilitation after unilateral total-hip arthroplasty. Reg Anesth Pain Med. 2005 Sep-Oct;30(5):452-7. doi: 10.1016/j.rapm.2005.05.008.

Stevens-Lapsley JE, Balter JE, Wolfe P, Eckhoff DG, Kohrt WM. Early neuromuscular electrical stimulation to improve quadriceps muscle strength after total knee arthroplasty: a randomized controlled trial. Phys Ther. 2012 Feb;92(2):210-26. doi: 10.2522/ptj.20110124. Epub 2011 Nov 17.

Thorsson O, Lilja B, Ahlgren L, Hemdal B, Westlin N. The effect of local cold application on intramuscular blood flow at rest and after running. Med Sci Sports Exerc. 1985 Dec;17(6):710-3. doi: 10.1249/00005768-198512000-00016. Erratum In: Med Sci Sports Exerc 1986 Dec;18(6):706.

Webb JM, Williams D, Ivory JP, Day S, Williamson DM. The use of cold compression dressings after total knee replacement: a randomized controlled trial. Orthopedics. 1998 Jan;21(1):59-61. doi: 10.3928/0147-7447-19980101-14.