Clinical trial NCT04814992: Pre-op Cognitive Behavior Therapy to Decrease Chronic Post-Surgical Pain in TKA
Official title: Pre-op CBT to Reduce the Risk for Development of Chronic Post-surgical Pain in Patients Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Post-Surgical Pain
Keywords: CPSP
Chronic Post-Surgical Pain
Cognitive Behavioral Therapy
Total Knee Arthroplasty
Motivational Interviewing
Opioid Taper
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 54
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized clinical trial is proposed to evaluate the efficacy of the novel computer-assisted preoperative CBT with integrating motivational interviewing intervention to affect acute and chronic post-operative pain outcomes. Specifically, 90 adult patients over the age of 21 meeting study inclusion criteria and preparing to undergo TKA at the Department of Orthopedic Surgery at Penn Presbyterian Medical Center, Penn Medicine University City, Penn Medicine Radnor, and Pennsylvania Hospital will be randomized to either receive the computer-assisted preoperative CBT intervention (n=45) or treatment-as-usual (control, n=45).
Primary purpose: TREATMENT

Brief summary: A significant number of patients develop chronic post-surgical pain (CPSP) following knee replacement surgery. Proposed is the testing of a novel computer-assisted behavioral intervention integrating motivational interviewing in the 4 weeks prior to surgery to address the risk factors for CPSP, with the expectation that severity of post-op pain and the incidence of CPSP will be reduced.

Detailed description: A significant number of patients develop chronic post-surgical pain following knee joint replacement surgery, and the risk factors for this problematic outcome have been identified. Proposed is the development and preliminary efficacy testing of a novel computer-assisted cognitive behavioral intervention integrating motivational interviewing delivered in the four weeks prior to surgery to address these risk factors, with the expectation that both the severity of post-operative pain and the subsequent incidence of chronic post-surgical pain will be reduced. In that chronic post-surgical pain brings with it diminished functionality and quality of life, ongoing opioid use, and direct patient costs, it is critical that interventions aimed at mitigating its development are implemented and evaluated in the clinical setting.

In a sample of adults over the age of 21 with chronic pain undergoing a planned TKA, the objectives of this randomized clinical trial are to:

1. Add a motivational interviewing component to a validated computer-assisted CBT intervention for chronic pain (painTRAINER) to encourage opioid tapering, if applicable, and program adherence in the 4 weeks prior to surgery in patients scheduled to undergo a TKA.
2. Describe the efficacy of the 4-week targeted pre-operative CBT intervention in 45 TKA patients to decrease preoperative chronic pain severity, preoperative opioid consumption, and symptoms of depression, anxiety and pain catastrophizing prior to surgery in comparison to 45 TKA patients randomized to treatment-as-usual.
3. Describe the effects of a 4-week targeted pre-operative CBT intervention in 45 TKA patients on 48hr post-operative pain severity, and 3- and 6-month rates of CPSP in comparison to 45 TKA patients randomized to treatment-as-usual.

Eligibility criteria: Inclusion Criteria:

1. Males and females, age \> 21 years
2. Chronic non-malignant pain of at least 3 months duration
3. Morphine equivalent daily dose (MEDD) \> 40 milligrams for at least 3 months
4. Able to enroll at least 4 weeks prior to planned surgery
5. Able to speak, read and comprehend in English at the 6th grade or higher proficiency

Exclusion Criteria:

1. Pain of malignant origin
2. Current or past history of opioid use disorder (including those on medication-assisted therapy)
3. Revision of TKA
4. Comorbid CNS disease such as dementia, HIV, psychosis, poorly controlled bipolar disorder or any condition interfering with informed consent

Primary outcomes:
measure: Preoperative Chronic Pain Severity
timeFrame: prior to surgery, approximately 6 weeks following baseline.
Secondary outcomes:
measure: Preoperative Opioid Use
timeFrame: prior to surgery, approximately 6 weeks following baseline
measure: Post-operative Opioid Use
timeFrame: 6-months
measure: Pre-Op Depression
timeFrame: pre-operation, approximately 6 weeks following baseline
measure: Post-Op Depression
timeFrame: 6-months
measure: Pre-Op Anxiety
timeFrame: pre-operation, approximately 6 weeks following baseline
measure: Post-Op Anxiety
timeFrame: 6-months
measure: Pre-Op Catastrophizing
timeFrame: pre-operation, approximately 6 weeks following baseline
measure: Post-Op Pain Severity
timeFrame: 48 hours post-operatively
measure: Chronic Post-Surgical Pain
timeFrame: 6-months
measure: Post-operative Chronic Pain Intensity
timeFrame: 6-months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine University City
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Radnor
country: United States
facility: Penn Medicine Radnor
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Martin D Cheatle, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Peggy Compton, RN, PhD, FAAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Inacio MCS, Paxton EW, Graves SE, Namba RS, Nemes S. Projected increase in total knee arthroplasty in the United States - an alternative projection model. Osteoarthritis Cartilage. 2017 Nov;25(11):1797-1803. doi: 10.1016/j.joca.2017.07.022. Epub 2017 Aug 8.
citation: Sloan M, Premkumar A, Sheth NP. Projected Volume of Primary Total Joint Arthroplasty in the U.S., 2014 to 2030. J Bone Joint Surg Am. 2018 Sep 5;100(17):1455-1460. doi: 10.2106/JBJS.17.01617.
citation: Lewis GN, Rice DA, McNair PJ, Kluger M. Predictors of persistent pain after total knee arthroplasty: a systematic review and meta-analysis. Br J Anaesth. 2015 Apr;114(4):551-61. doi: 10.1093/bja/aeu441. Epub 2014 Dec 26.
citation: Petersen KK, Simonsen O, Laursen MB, Nielsen TA, Rasmussen S, Arendt-Nielsen L. Chronic postoperative pain after primary and revision total knee arthroplasty. Clin J Pain. 2015 Jan;31(1):1-6. doi: 10.1097/AJP.0000000000000146.
citation: Petersen KK, Graven-Nielsen T, Simonsen O, Laursen MB, Arendt-Nielsen L. Preoperative pain mechanisms assessed by cuff algometry are associated with chronic postoperative pain relief after total knee replacement. Pain. 2016 Jul;157(7):1400-1406. doi: 10.1097/j.pain.0000000000000531.
citation: Schug SA, Bruce J. Risk stratification for the development of chronic postsurgical pain. Pain Rep. 2017 Oct 31;2(6):e627. doi: 10.1097/PR9.0000000000000627. eCollection 2017 Nov.
citation: Lavand'homme P. Transition from acute to chronic pain after surgery. Pain. 2017 Apr;158 Suppl 1:S50-S54. doi: 10.1097/j.pain.0000000000000809. No abstract available.
citation: Richebe P, Capdevila X, Rivat C. Persistent Postsurgical Pain: Pathophysiology and Preventative Pharmacologic Considerations. Anesthesiology. 2018 Sep;129(3):590-607. doi: 10.1097/ALN.0000000000002238.
citation: Goesling J, Moser SE, Zaidi B, Hassett AL, Hilliard P, Hallstrom B, Clauw DJ, Brummett CM. Trends and predictors of opioid use after total knee and total hip arthroplasty. Pain. 2016 Jun;157(6):1259-1265. doi: 10.1097/j.pain.0000000000000516.
citation: Westermann RW, Anthony CA, Bedard N, Glass N, Bollier M, Hettrich CM, Wolf BR. Opioid Consumption After Rotator Cuff Repair. Arthroscopy. 2017 Aug;33(8):1467-1472. doi: 10.1016/j.arthro.2017.03.016. Epub 2017 May 29.
citation: Parsons B, Schaefer C, Mann R, Sadosky A, Daniel S, Nalamachu S, Stacey BR, Nieshoff EC, Tuchman M, Anschel A. Economic and humanistic burden of post-trauma and post-surgical neuropathic pain among adults in the United States. J Pain Res. 2013 Jun 17;6:459-69. doi: 10.2147/JPR.S44939. Print 2013.
citation: Katz J, Seltzer Z. Transition from acute to chronic postsurgical pain: risk factors and protective factors. Expert Rev Neurother. 2009 May;9(5):723-44. doi: 10.1586/ern.09.20.
citation: Borsook D, Youssef AM, Simons L, Elman I, Eccleston C. When pain gets stuck: the evolution of pain chronification and treatment resistance. Pain. 2018 Dec;159(12):2421-2436. doi: 10.1097/j.pain.0000000000001401.
citation: Althaus A, Hinrichs-Rocker A, Chapman R, Arranz Becker O, Lefering R, Simanski C, Weber F, Moser KH, Joppich R, Trojan S, Gutzeit N, Neugebauer E. Development of a risk index for the prediction of chronic post-surgical pain. Eur J Pain. 2012 Jul;16(6):901-10. doi: 10.1002/j.1532-2149.2011.00090.x. Epub 2011 Dec 23.
citation: Buvanendran A, Della Valle CJ, Kroin JS, Shah M, Moric M, Tuman KJ, McCarthy RJ. Acute postoperative pain is an independent predictor of chronic postsurgical pain following total knee arthroplasty at 6 months: a prospective cohort study. Reg Anesth Pain Med. 2019 Mar;44(3):e100036. doi: 10.1136/rapm-2018-100036. Epub 2019 Feb 15.
citation: Eisenach JC, Brennan TJ. Pain after surgery. Pain. 2018 Jun;159(6):1010-1011. doi: 10.1097/j.pain.0000000000001223. No abstract available.
citation: Raja SN, Jensen TS. Predicting postoperative pain based on preoperative pain perception: are we doing better than the weatherman? Anesthesiology. 2010 Jun;112(6):1311-2. doi: 10.1097/ALN.0b013e3181dcd5cc. No abstract available.
citation: McDonald S, Page MJ, Beringer K, Wasiak J, Sprowson A. Preoperative education for hip or knee replacement. Cochrane Database Syst Rev. 2014 May 13;2014(5):CD003526. doi: 10.1002/14651858.CD003526.pub3.
citation: Riddle DL, Keefe FJ, Ang DC, Slover J, Jensen MP, Bair MJ, Kroenke K, Perera RA, Reed SD, McKee D, Dumenci L. Pain Coping Skills Training for Patients Who Catastrophize About Pain Prior to Knee Arthroplasty: A Multisite Randomized Clinical Trial. J Bone Joint Surg Am. 2019 Feb 6;101(3):218-227. doi: 10.2106/JBJS.18.00621.
citation: Gibson E, Sabo MT. Can pain catastrophizing be changed in surgical patients? A scoping review. Can J Surg. 2018 Oct 1;61(5):311-318. doi: 10.1503/cjs.015417.
citation: Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016. MMWR Recomm Rep. 2016 Mar 18;65(1):1-49. doi: 10.15585/mmwr.rr6501e1.
citation: Schug SA, Lavand'homme P, Barke A, Korwisi B, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic postsurgical or posttraumatic pain. Pain. 2019 Jan;160(1):45-52. doi: 10.1097/j.pain.0000000000001413.
citation: Borsook D, Kussman BD, George E, Becerra LR, Burke DW. Surgically induced neuropathic pain: understanding the perioperative process. Ann Surg. 2013 Mar;257(3):403-12. doi: 10.1097/SLA.0b013e3182701a7b.
citation: Suzan E, Pud D, Eisenberg E. A crucial administration timing separates between beneficial and counterproductive effects of opioids on postoperative pain. Pain. 2018 Aug;159(8):1438-1440. doi: 10.1097/j.pain.0000000000001200. No abstract available.
citation: McAnally H. Rationale for and approach to preoperative opioid weaning: a preoperative optimization protocol. Perioper Med (Lond). 2017 Nov 22;6:19. doi: 10.1186/s13741-017-0079-y. eCollection 2017.
citation: Glare P, Aubrey KR, Myles PS. Transition from acute to chronic pain after surgery. Lancet. 2019 Apr 13;393(10180):1537-1546. doi: 10.1016/S0140-6736(19)30352-6.
citation: Weber L, Yeomans DC, Tzabazis A. Opioid-induced hyperalgesia in clinical anesthesia practice: what has remained from theoretical concepts and experimental studies? Curr Opin Anaesthesiol. 2017 Aug;30(4):458-465. doi: 10.1097/ACO.0000000000000485.
citation: Beck JS. Cognitive behavior therapy: Basics and beyond (2nd ed.). (2011) New York, NY: The Guilford Press.
citation: Turk DC, Flor H. Etiological theories and treatments for chronic back pain. II. Psychological models and interventions. Pain. 1984 Jul;19(3):209-233. doi: 10.1016/0304-3959(84)90001-0.
citation: Knoerl R, Lavoie Smith EM, Weisberg J. Chronic Pain and Cognitive Behavioral Therapy: An Integrative Review. West J Nurs Res. 2016 May;38(5):596-628. doi: 10.1177/0193945915615869. Epub 2015 Nov 24.
citation: Baez S, Hoch MC, Hoch JM. Evaluation of Cognitive Behavioral Interventions and Psychoeducation Implemented by Rehabilitation Specialists to Treat Fear-Avoidance Beliefs in Patients With Low Back Pain: A Systematic Review. Arch Phys Med Rehabil. 2018 Nov;99(11):2287-2298. doi: 10.1016/j.apmr.2017.11.003. Epub 2017 Dec 14.
citation: Vugts MAP, Joosen MCW, van der Geer JE, Zedlitz AMEE, Vrijhoef HJM. The effectiveness of various computer-based interventions for patients with chronic pain or functional somatic syndromes: A systematic review and meta-analysis. PLoS One. 2018 May 16;13(5):e0196467. doi: 10.1371/journal.pone.0196467. eCollection 2018.
citation: Eccleston C, Hearn L, Williams AC. Psychological therapies for the management of chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2015 Oct 29;2015(10):CD011259. doi: 10.1002/14651858.CD011259.pub2.
citation: Macea DD, Gajos K, Daglia Calil YA, Fregni F. The efficacy of Web-based cognitive behavioral interventions for chronic pain: a systematic review and meta-analysis. J Pain. 2010 Oct;11(10):917-29. doi: 10.1016/j.jpain.2010.06.005. Epub 2010 Jul 22.
citation: Bender JL, Radhakrishnan A, Diorio C, Englesakis M, Jadad AR. Can pain be managed through the Internet? A systematic review of randomized controlled trials. Pain. 2011 Aug;152(8):1740-1750. doi: 10.1016/j.pain.2011.02.012. Epub 2011 May 11.
citation: Aggarwal VR, Fu Y, Main CJ, Wu J. The effectiveness of self-management interventions in adults with chronic orofacial pain: A systematic review, meta-analysis and meta-regression. Eur J Pain. 2019 May;23(5):849-865. doi: 10.1002/ejp.1358. Epub 2019 Feb 7.
citation: Monticone M, Ambrosini E, Cedraschi C, Rocca B, Fiorentini R, Restelli M, Gianola S, Ferrante S, Zanoli G, Moja L. Cognitive-behavioral Treatment for Subacute and Chronic Neck Pain: A Cochrane Review. Spine (Phila Pa 1976). 2015 Oct 1;40(19):1495-504. doi: 10.1097/BRS.0000000000001052.
citation: Ehde DM, Dillworth TM, Turner JA. Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. Am Psychol. 2014 Feb-Mar;69(2):153-66. doi: 10.1037/a0035747.
citation: Rini C, Porter LS, Somers TJ, McKee DC, DeVellis RF, Smith M, Winkel G, Ahern DK, Goldman R, Stiller JL, Mariani C, Patterson C, Jordan JM, Caldwell DS, Keefe FJ. Automated Internet-based pain coping skills training to manage osteoarthritis pain: a randomized controlled trial. Pain. 2015 May;156(5):837-848. doi: 10.1097/j.pain.0000000000000121.
citation: Bennell KL, Nelligan R, Dobson F, Rini C, Keefe F, Kasza J, French S, Bryant C, Dalwood A, Abbott JH, Hinman RS. Effectiveness of an Internet-Delivered Exercise and Pain-Coping Skills Training Intervention for Persons With Chronic Knee Pain: A Randomized Trial. Ann Intern Med. 2017 Apr 4;166(7):453-462. doi: 10.7326/M16-1714. Epub 2017 Feb 21.
citation: Bennell KL, Nelligan RK, Rini C, Keefe FJ, Kasza J, French S, Forbes A, Dobson F, Abbott JH, Dalwood A, Harris A, Vicenzino B, Hodges PW, Hinman RS. Effects of internet-based pain coping skills training before home exercise for individuals with hip osteoarthritis (HOPE trial): a randomised controlled trial. Pain. 2018 Sep;159(9):1833-1842. doi: 10.1097/j.pain.0000000000001281.
citation: Cassin SE, Sockalingam S, Du C, Wnuk S, Hawa R, Parikh SV. A pilot randomized controlled trial of telephone-based cognitive behavioural therapy for preoperative bariatric surgery patients. Behav Res Ther. 2016 May;80:17-22. doi: 10.1016/j.brat.2016.03.001. Epub 2016 Mar 10.
citation: Gade H, Friborg O, Rosenvinge JH, Smastuen MC, Hjelmesaeth J. The Impact of a Preoperative Cognitive Behavioural Therapy (CBT) on Dysfunctional Eating Behaviours, Affective Symptoms and Body Weight 1 Year after Bariatric Surgery: A Randomised Controlled Trial. Obes Surg. 2015 Nov;25(11):2112-9. doi: 10.1007/s11695-015-1673-z.
citation: Lotzke H, Brisby H, Gutke A, Hagg O, Jakobsson M, Smeets R, Lundberg M. A Person-Centered Prehabilitation Program Based on Cognitive-Behavioral Physical Therapy for Patients Scheduled for Lumbar Fusion Surgery: A Randomized Controlled Trial. Phys Ther. 2019 Aug 1;99(8):1069-1088. doi: 10.1093/ptj/pzz020.
citation: Wang L, Lee M, Zhang Z, Moodie J, Cheng D, Martin J. Does preoperative rehabilitation for patients planning to undergo joint replacement surgery improve outcomes? A systematic review and meta-analysis of randomised controlled trials. BMJ Open. 2016 Feb 2;6(2):e009857. doi: 10.1136/bmjopen-2015-009857.
citation: das Nair R, Mhizha-Murira JR, Anderson P, Carpenter H, Clarke S, Groves S, Leighton P, Scammell BE, Topcu G, Walsh DA, Lincoln NB. Home-based pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): a feasibility randomized controlled trial. Clin Rehabil. 2018 Jun;32(6):777-789. doi: 10.1177/0269215518755426. Epub 2018 Feb 9.
citation: Eccleston C, Fisher E, Thomas KH, Hearn L, Derry S, Stannard C, Knaggs R, Moore RA. Interventions for the reduction of prescribed opioid use in chronic non-cancer pain. Cochrane Database Syst Rev. 2017 Nov 13;11(11):CD010323. doi: 10.1002/14651858.CD010323.pub3.
citation: Jung HJ, Yu ES, Kim JH. Combined Program of Cognitive-Behavioral Therapy for Insomnia and Medication Tapering in Cancer Patients: A Clinic-Based Pilot Study. Behav Sleep Med. 2020 May-Jun;18(3):386-395. doi: 10.1080/15402002.2019.1597718. Epub 2019 Apr 9.
citation: Butler SF, Budman SH, Fernandez KC, Houle B, Benoit C, Katz N, Jamison RN. Development and validation of the Current Opioid Misuse Measure. Pain. 2007 Jul;130(1-2):144-56. doi: 10.1016/j.pain.2007.01.014. Epub 2007 May 9.
citation: Cleeland CS. Measurement of pain by subjective report. In: Chapman CR, Loeser JD, editors. Issues in Pain Measurement. New York: Raven Press; pp. 391-403, 1989 Advances in Pain Research and Therapy; Vol. 12.
citation: Sullivan MJ, Bishop SR, Pivik J. The Pain Catastrophizing Scale: Development and Validation. Psychological Assessment 1995; 7(4): 524-532.
citation: Littell RC, Milli GA, Stroup WW, Wolfinger RD. SAS System for Mixed Models, Cary, NC: SAS Institute Inc., 1996, pp. 633.
citation: SAS Institute Inc. 2013. Base SAS® 9.4 Procedures Guide: Statistical Procedures, Second Edition. Cary, NC: SAS Institute Inc
citation: Little RJA. Modeling the drop-out mechanism in repeated-measures studies. Journal of the American Statistical Association. 1995;90:1112-21.
citation: Allison PD. Missing Data. Sage University Papers Series on Quantitative Applications in the Social Sciences, 2001; 07-136. Thousand Oaks, CA: Sage.