Clinical trial NCT04798573: Phenomics and Genomics of Clinically Relevant Chronic Postsurgical Pain
Official title: Phenomics and Genomics of Clinically Relevant Chronic Postsurgical Pain: A Multicenter Prospective Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Pain
Surgery
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elective cardiac and thoracic surgery patients who agree to participate in the study

Brief summary: The investigators will approach elective cardiac and thoracic surgery patients in the preoperative consultation clinic. Consenting individuals will be administered, before surgery validated pain, psychological and sleep questionnaires. These questionnaires will be repeated at 3, 6 and 12 months postoperatively (PO) to follow up the progression of early PO pain and the transition to chronicity. Participants will define clinically relevant pain by calculating a chronic pain index (CPI). In addition, the investigators will follow the development of acute postsurgical and chronic pain from before surgery up to a year after, extract DNA from blood and contrast the genetic variations of participants with clinically significant chronic pain, to identify variations associated with the development of chronic post-surgical pain.

Detailed description: Most patients who undergo surgery heal within weeks to months and return to their baseline functional status or to an improved level of functioning. However, some patients have pain after surgery which continues. The purpose of this study is to see if there is a relationship between patient's genetic makeup (diseases that are passed on in families) and pain experience following cardiac and thoracic surgeries. This study will look for links between psychological factors, environmental factors and genetic factors in an attempt to uncover the risk for developing chronic post-surgical pain.

This study hopes to determine differences between traditional pain surveys and a basic science approach called "Phenomics" to measure chronic pain response after cardiac and thoracic surgery. Phenomics or Phenomes is the study of physical characteristics, outside influences and biochemical changes (traits or chemical characteristics) and their response to either the environment or genetic changes. Validated pain questionnaires will be administered before surgery, and will repeated at 3, 6, and 12 months postoperatively to follow up the progression of early postoperative pain and the transition to chronicity. In general, the psychological and pain questionnaires are designed to measure the following: anxiety, thoughts, feelings and reactions toward pain and stressful experiences.

In addition, the study will follow the development of acute postoperative and chronic pain from before surgery up to a year after. The investigators will extract DNA from blood and contrast the genetic variations of participants with clinically significant chronic pain, to identify variations associated with the development of chronic post-surgical pain. The blood sample will be drawn at the time of the surgery.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Non- Emergency Cardiac Surgery with Midline Sternotomy OR Thoracic Surgery via VATS or Lateral Thoracotomy
3. Written informed consent to participate in the study

Exclusion Criteria:

1. Patient unable to understand the study protocol
2. History of a psychotic psychiatric disorder
3. Unable to speak English

Primary outcomes:
measure: Post-Surgical Pain Intensity
timeFrame: 1 year from the day of surgery
measure: Pain: Measured using the McGill Pain Questionnaire- Short Form-2 (SF-MPQ-2)
timeFrame: 1 year from the day of surgery
measure: Pain: Measured using the Self-completed Leeds Assessment of Neuropathic Symptoms and Signs (SLANSS)
timeFrame: 1 year from the day of surgery
measure: Anxiety: Measured using the Anxiety Sensitivity Index-3 (ASI-3)
timeFrame: 1 year from the day of surgery
measure: Pain Catastrophizing: Measured using the Pain Catastrophizing Scale (PCS)
timeFrame: 1 year from the day of surgery
measure: Pain Anxiety: Measured using the Pain Anxiety Symptoms Scale-20 (PASS-20)
timeFrame: 1 year from the day of surgery
measure: Pain Disability: Measured using the Pain Disability Index (PDI)
timeFrame: 1 year from the day of surgery
measure: Posttraumatic Stress Disorder: Measured using the Posttraumatic Stress Disorder Checklist-Civilian Version (PCL-C)
timeFrame: 1 year from the day of surgery
measure: Anxiety and Depression: Measured using The Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1 year from the day of surgery
measure: Somatization: Measured using the SCL-90-R-Somatization
timeFrame: 1 year from the day of surgery
measure: Chronic Pain Acceptance: Measured using the Chronic Pain Acceptance Questionnaire (CPAQ)
timeFrame: 1 year from the day of surgery
measure: Mindful Attention Awareness: Measured using the Mindful Attention Awareness Scale (MAAS)
timeFrame: 1 year from the day of surgery
measure: Pain Self Efficacy: Measured using the Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: 1 year from the day of surgery
measure: Sensitivity to Pain Traumatization: Measured using the Sensitivity to Pain Traumatization Scale (SPTS)
timeFrame: 1 year from the day of surgery
measure: Sleep Problems: Measured using the Sleep Problems Questionnaire
timeFrame: 1 year from the day of surgery
measure: Sleep Quality: Measured using the Pittsburg Sleep Quality Index (PQSI)
timeFrame: 1 year from the day of surgery
Secondary outcomes:
measure: Physical Activity for Thoracic Patients: Measured using Actiwatch--64
timeFrame: Up to 11 days from surgery
measure: Sleep Quality for Thoracic Patients: Measured using the Sleep Quality Assessment
timeFrame: Up to 11 days from surgery
measure: Mechanical Pain Pressure: Measured using the Mechanical Pressure Pain Threshold (PPT)
timeFrame: 1 year from the day of surgery
measure: Thermal Pain and Sensory: Measured using the Thermal Pain and Sensory Thresholds
timeFrame: 1 year from the day of surgery
measure: Pain Illusion: Measured using the Thermal Grill Illusion Test
timeFrame: 1 year from the day of surgery
measure: Pain: Measured using the Vasoconstrictor Inspiratory Gasp
timeFrame: 1 year from the day of surgery
measure: Cold Pressor Pain: Measured using the Cold Pressor Pain Test
timeFrame: 1 year from the day of surgery
Other outcomes:
measure: Genotyping Outcomes- DNA and Biomarkers
timeFrame: From pre-surgery to 3 month post-surgically
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Hance Clarke, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ohayon MM, Schatzberg AF. Chronic pain and major depressive disorder in the general population. J Psychiatr Res. 2010 May;44(7):454-61. doi: 10.1016/j.jpsychires.2009.10.013. Epub 2010 Feb 9.
citation: Wall PD, Jones M. Defeating pain: The war against a silent epidemic. New York, NY: Plenum Press; 1991.
citation: McCarberg BH, Billington R. Consequences of neuropathic pain: quality-of-life issues and associated costs. Am J Manag Care. 2006 Jun;12(9 Suppl):S263-8.
citation: Diatchenko L, Slade GD, Nackley AG, Bhalang K, Sigurdsson A, Belfer I, Goldman D, Xu K, Shabalina SA, Shagin D, Max MB, Makarov SS, Maixner W. Genetic basis for individual variations in pain perception and the development of a chronic pain condition. Hum Mol Genet. 2005 Jan 1;14(1):135-43. doi: 10.1093/hmg/ddi013. Epub 2004 Nov 10.
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: Max MB, Stewart WF. The molecular epidemiology of pain: a new discipline for drug discovery. Nat Rev Drug Discov. 2008 Aug;7(8):647-58. doi: 10.1038/nrd2595. Epub 2008 Jun 27.
citation: Seltzer Z, Dorfman R. Identifying genetic and environmental risk factors for chronic orofacial pain syndromes: human models. J Orofac Pain. 2004 Fall;18(4):311-7.
citation: Seltzer Z, Mogil JS. Pain and genetics. In: Sessle BJ, Lavigne GJ, Lund JP, Dubner R (eds). Orofacial Pain and Related Conditions. 2nd edition ed. Hanover Park, Illinois: Quintessence Publishing, 2008:69-75.
citation: Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
citation: Crombie IK, Davies HT, Macrae WA. Cut and thrust: antecedent surgery and trauma among patients attending a chronic pain clinic. Pain. 1998 May;76(1-2):167-71.
citation: King KM, Tsuyuki R, Faris P, Currie G, Maitland A, Collins-Nakai RL. A randomized controlled trial of women's early use of a novel undergarment following sternotomy: the Women's Recovery from Sternotomy Trial (WREST). Am Heart J. 2006 Dec;152(6):1187-93. doi: 10.1016/j.ahj.2006.07.026.
citation: King KM, Parry M, Southern D, Faris P, Tsuyuki RT. Women's Recovery from Sternotomy-Extension (WREST-E) study: examining long-term pain and discomfort following sternotomy and their predictors. Heart. 2008 Apr;94(4):493-7. doi: 10.1136/hrt.2007.117606. Epub 2007 Jul 16.
citation: Lahtinen P, Kokki H, Hynynen M. Pain after cardiac surgery: a prospective cohort study of 1-year incidence and intensity. Anesthesiology. 2006 Oct;105(4):794-800. doi: 10.1097/00000542-200610000-00026.
citation: Meyerson J, Thelin S, Gordh T, Karlsten R. The incidence of chronic post-sternotomy pain after cardiac surgery--a prospective study. Acta Anaesthesiol Scand. 2001 Sep;45(8):940-4. doi: 10.1034/j.1399-6576.2001.450804.x.
citation: Routledge FS, Tsuyuki RT, Hervas-Malo M, LeBlanc P, McFetridge-Durdle JA, King KM. The influence of coronary artery bypass graft harvest site on women's pain, functional status, and health services utilization throughout the first post-operative year: a longitudinal study. Int J Nurs Stud. 2009 Aug;46(8):1054-60. doi: 10.1016/j.ijnurstu.2009.02.003. Epub 2009 Mar 9.
citation: Lopez V, Sek Ying C, Poon CY, Wai Y. Physical, psychological and social recovery patterns after coronary artery bypass graft surgery: a prospective repeated measures questionnaire survey. Int J Nurs Stud. 2007 Nov;44(8):1304-15. doi: 10.1016/j.ijnurstu.2006.06.005. Epub 2006 Aug 30.
citation: Gjeilo KH, Stenseth R, Wahba A, Lydersen S, Klepstad P. Validation of the brief pain inventory in patients six months after cardiac surgery. J Pain Symptom Manage. 2007 Dec;34(6):648-56. doi: 10.1016/j.jpainsymman.2007.01.010. Epub 2007 Jul 16.
citation: Wildgaard K, Ravn J, Nikolajsen L, Jakobsen E, Jensen TS, Kehlet H. Consequences of persistent pain after lung cancer surgery: a nationwide questionnaire study. Acta Anaesthesiol Scand. 2011 Jan;55(1):60-8. doi: 10.1111/j.1399-6576.2010.02357.x. Epub 2010 Nov 15.
citation: Kristensen AD, Pedersen TA, Hjortdal VE, Jensen TS, Nikolajsen L. Chronic pain in adults after thoracotomy in childhood or youth. Br J Anaesth. 2010 Jan;104(1):75-9. doi: 10.1093/bja/aep317.
citation: Steegers MA, Snik DM, Verhagen AF, van der Drift MA, Wilder-Smith OH. Only half of the chronic pain after thoracic surgery shows a neuropathic component. J Pain. 2008 Oct;9(10):955-61. doi: 10.1016/j.jpain.2008.05.009. Epub 2008 Jul 16.
citation: Maguire MF, Ravenscroft A, Beggs D, Duffy JP. A questionnaire study investigating the prevalence of the neuropathic component of chronic pain after thoracic surgery. Eur J Cardiothorac Surg. 2006 May;29(5):800-5. doi: 10.1016/j.ejcts.2006.02.002. Epub 2006 Apr 3.
citation: Kalso E, Perttunen K, Kaasinen S. Pain after thoracic surgery. Acta Anaesthesiol Scand. 1992 Jan;36(1):96-100. doi: 10.1111/j.1399-6576.1992.tb03430.x.
citation: Bruce J, Drury N, Poobalan AS, Jeffrey RR, Smith WC, Chambers WA. The prevalence of chronic chest and leg pain following cardiac surgery: a historical cohort study. Pain. 2003 Jul;104(1-2):265-73. doi: 10.1016/s0304-3959(03)00017-4.
citation: Eisenberg E, Pultorak Y, Pud D, Bar-El Y. Prevalence and characteristics of post coronary artery bypass graft surgery pain (PCP). Pain. 2001 May;92(1-2):11-7. doi: 10.1016/s0304-3959(00)00466-8.
citation: Kalso E, Mennander S, Tasmuth T, Nilsson E. Chronic post-sternotomy pain. Acta Anaesthesiol Scand. 2001 Sep;45(8):935-9. doi: 10.1034/j.1399-6576.2001.450803.x.
citation: Steegers MA, van de Luijtgaarden A, Noyez L, Scheffer GJ, Wilder-Smith OH. The role of angina pectoris in chronic pain after coronary artery bypass graft surgery. J Pain. 2007 Aug;8(8):667-73. doi: 10.1016/j.jpain.2007.04.007. Epub 2007 Jun 13.
citation: Searle RD, Simpson MP, Simpson KH, Milton R, Bennett MI. Can chronic neuropathic pain following thoracic surgery be predicted during the postoperative period? Interact Cardiovasc Thorac Surg. 2009 Dec;9(6):999-1002. doi: 10.1510/icvts.2009.216887. Epub 2009 Sep 18.
citation: Katz J, Asmundson GJ, McRae K, Halket E. Emotional numbing and pain intensity predict the development of pain disability up to one year after lateral thoracotomy. Eur J Pain. 2009 Sep;13(8):870-8. doi: 10.1016/j.ejpain.2008.10.003. Epub 2008 Nov 21.
citation: Gottschalk A, Ochroch EA. Clinical and demographic characteristics of patients with chronic pain after major thoracotomy. Clin J Pain. 2008 Oct;24(8):708-16. doi: 10.1097/AJP.0b013e318174badd.
citation: Senturk M, Ozcan PE, Talu GK, Kiyan E, Camci E, Ozyalcin S, Dilege S, Pembeci K. The effects of three different analgesia techniques on long-term postthoracotomy pain. Anesth Analg. 2002 Jan;94(1):11-5, table of contents. doi: 10.1213/00000539-200201000-00003.
citation: Guastella V, Mick G, Soriano C, Vallet L, Escande G, Dubray C, Eschalier A. A prospective study of neuropathic pain induced by thoracotomy: incidence, clinical description, and diagnosis. Pain. 2011 Jan;152(1):74-81. doi: 10.1016/j.pain.2010.09.004. Epub 2010 Nov 13.
citation: Gjeilo KH, Klepstad P, Wahba A, Lydersen S, Stenseth R. Chronic pain after cardiac surgery: a prospective study. Acta Anaesthesiol Scand. 2010 Jan;54(1):70-8. doi: 10.1111/j.1399-6576.2009.02097.x. Epub 2009 Aug 13.
citation: Choinière M, Watt-Watson J, Costello J, Guerriere D, Carrier M, Cogan M, Bussieres J, Guertin MC, Lespérance F, Basket R, McFetridge-Durdle J, Sullivan J. Prevalence, characterictics, and risk factors of persistent post-operative pain after cardiac surgery. Pain Research and Management. 2009;14(2):144.
citation: Katz J. Pain begets pain - Predictors of long-term phantom limb pain and post-thoracotomy pain. Pain Forum. 1997;6:140-4.
citation: Katz J, Jackson M, Kavanagh BP, Sandler AN. Acute pain after thoracic surgery predicts long-term post-thoracotomy pain. Clin J Pain. 1996 Mar;12(1):50-5. doi: 10.1097/00002508-199603000-00009.
citation: Kidd BL, Urban LA. Mechanisms of inflammatory pain. Br J Anaesth. 2001 Jul;87(1):3-11. doi: 10.1093/bja/87.1.3. No abstract available.
citation: Tajerian M, Clark JD. The role of the extracellular matrix in chronic pain following injury. Pain. 2015 Mar;156(3):366-370. doi: 10.1097/01.j.pain.0000460323.80020.9d. No abstract available.
citation: Kim H, Ramsay E, Lee H, Wahl S, Dionne RA. Genome-wide association study of acute post-surgical pain in humans. Pharmacogenomics. 2009 Feb;10(2):171-9. doi: 10.2217/14622416.10.2.171.
citation: Lu Y, Belfer I, Vatine JJ, Shir Y, Jablonski-Peetz T, Pfeffer RM, Hipp H, Sun L, Craiu R, Goldman D, Max MB, Seltzer Z. Neuropathic pain levels following surgical nerve injury are controlled by genotypes and haplotypes of COMT - the gene encoding catecholamine-o-methyltransferase.Second International Conference on Neuropathic Pain. Berlin, Germany, 2007.
citation: Lu Y, Belfer I, Gershon E, Vatine JJ, Shir Y, Jablonski-Peetz T, Pfeffer RM, Hipp H, Livneh J, Goldman D, Max M, Seltzer Z. Do GCH1 polymorphisms control the risk for developing chronic pain in leg amputees and women postmastectomy? . Canadian Association of Genetic Epidemiology. Toronto, Canada, 2007.
citation: Seltzer Z. Studying candidate genes for chronic pain: the example of COMT, the gene encoding Catechol-O-methyltransferase. 5th Congress of the European Federation of IASP Chapters (EFIC). Istanbul, Turkey 2006:13-6.
citation: Nissenbaum J, Devor M, Seltzer Z, Gebauer M, Michaelis M, Tal M, Dorfman R, Abitbul-Yarkoni M, Lu Y, Elahipanah T, delCanho S, Minert A, Fried K, Persson AK, Shpigler H, Shabo E, Yakir B, Pisante A, Darvasi A. Susceptibility to chronic pain following nerve injury is genetically affected by CACNG2. Genome Res. 2010 Sep;20(9):1180-90. doi: 10.1101/gr.104976.110. Epub 2010 Aug 5.
citation: Costigan M, Belfer I, Griffin RS, Dai F, Barrett LB, Coppola G, Wu T, Kiselycznyk C, Poddar M, Lu Y, Diatchenko L, Smith S, Cobos EJ, Zaykin D, Allchorne A, Gershon E, Livneh J, Shen PH, Nikolajsen L, Karppinen J, Mannikko M, Kelempisioti A, Goldman D, Maixner W, Geschwind DH, Max MB, Seltzer Z, Woolf CJ. Multiple chronic pain states are associated with a common amino acid-changing allele in KCNS1. Brain. 2010 Sep;133(9):2519-27. doi: 10.1093/brain/awq195. Epub 2010 Aug 18.
citation: Sackstein M, Ramer A, Seltzer Z. Specific patterns of injury discharge are associated with receptor types in freshly injured sensory myelinated (A-) and unmyelinated (C-) fibers in rat. 8th World Congress on Pain. Vancouver, Canada, 1996.
citation: Seltzer Z, Beilin B, Ginzburg R, Paran Y, Shimko T. The role of injury discharge in the induction of neuropathic pain behavior in rats. Pain. 1991 Sep;46(3):327-336. doi: 10.1016/0304-3959(91)90115-E.
citation: Seltzer Z, Cohn S, Ginzburg R, Beilin B. Modulation of neuropathic pain behavior in rats by spinal disinhibition and NMDA receptor blockade of injury discharge. Pain. 1991 Apr;45(1):69-75. doi: 10.1016/0304-3959(91)90166-U.
citation: Cohn S, Seltzer Z. Inherited propensity for neuropathic pain is mediated by sensitivity to injury discharge. Neuroreport. 1991 Nov;2(11):647-50. doi: 10.1097/00001756-199111000-00003.
citation: Sabsovich I, Neumann R, Dorfman J, Storm-Mathisen OP, Otterson P, Raber R, Zeltser R, Cevor M, Seltzer Z. Spinal dorsal horn inhibitory amino acid neurons: genetic differences and response to peripheral neurectomy. 3rd Congress of the European Federation of IASP Chapters (EFIC). Nice, France, 2000.
citation: Zhang SH, Blech-Hermoni Y, Faravelli L, Seltzer Z. Ralfinamide administered orally before hindpaw neurectomy or postoperatively provided long-lasting suppression of spontaneous neuropathic pain-related behavior in the rat. Pain. 2008 Oct 15;139(2):293-305. doi: 10.1016/j.pain.2008.04.020. Epub 2008 Jun 25.
citation: Katz J, Clarke H. Preventive analgesia and beyond: Current status, evidence, and future directions. In: Macintyre PE, Rowbotham DJ, Howard R (eds). Clinical pain management: Acute pain 2nd ed. London: Hodder Arnold Ltd, 2008:154-98.
citation: McCartney CJ, Sinha A, Katz J. A qualitative systematic review of the role of N-methyl-D-aspartate receptor antagonists in preventive analgesia. Anesth Analg. 2004 May;98(5):1385-400, table of contents. doi: 10.1213/01.ane.0000108501.57073.38.
citation: Katz J, Schmid R, Snijdelaar DG, Coderre TJ, McCartney CJL, Wowk A. Pre-emptive analgesia using intravenous fentanyl plus low-dose ketamine for radical prostatectomy under general anesthesia does not produce short-term or long-term reductions in pain or analgesic use. Pain. 2004 Aug;110(3):707-718. doi: 10.1016/j.pain.2004.05.011.
citation: Clarke H, Pereira S, Kennedy D, Andrion J, Mitsakakis N, Gollish J, Katz J, Kay J. Adding gabapentin to a multimodal regimen does not reduce acute pain, opioid consumption or chronic pain after total hip arthroplasty. Acta Anaesthesiol Scand. 2009 Sep;53(8):1073-83. doi: 10.1111/j.1399-6576.2009.02039.x. Epub 2009 Jun 30.
citation: Clarke H, Pereira S, Kennedy D, Gilron I, Katz J, Gollish J, Kay J. Gabapentin decreases morphine consumption and improves functional recovery following total knee arthroplasty. Pain Res Manag. 2009 May-Jun;14(3):217-22. doi: 10.1155/2009/930609.
citation: Snijdelaar DG, Cornelisse HB, Schmid RL, Katz J. A randomised, controlled study of peri-operative low dose s(+)-ketamine in combination with postoperative patient-controlled s(+)-ketamine and morphine after radical prostatectomy. Anaesthesia. 2004 Mar;59(3):222-8. doi: 10.1111/j.1365-2044.2003.03620.x.
citation: Snijdelaar DG, Koren G, Katz J. Effects of perioperative oral amantadine on postoperative pain and morphine consumption in patients after radical prostatectomy: results of a preliminary study. Anesthesiology. 2004 Jan;100(1):134-41. doi: 10.1097/00000542-200401000-00022.
citation: Katz J, Clarke H, Seltzer Z. Review article: Preventive analgesia: quo vadimus? Anesth Analg. 2011 Nov;113(5):1242-53. doi: 10.1213/ANE.0b013e31822c9a59. Epub 2011 Sep 30.
citation: Novak CB, Anastakis DJ, Beaton DE, Katz J. Patient-reported outcome after peripheral nerve injury. J Hand Surg Am. 2009 Feb;34(2):281-7. doi: 10.1016/j.jhsa.2008.11.017.
citation: Gibas AL, Klatt R, Johnson J, Clarke JT, Katz J. A survey of the pain experienced by males and females with Fabry disease. Pain Res Manag. 2006 Autumn;11(3):185-92. doi: 10.1155/2006/828964.
citation: Cohen L, Fouladi RT, Katz J. Preoperative coping strategies and distress predict postoperative pain and morphine consumption in women undergoing abdominal gynecologic surgery. J Psychosom Res. 2005 Feb;58(2):201-9. doi: 10.1016/j.jpsychores.2004.07.007.
citation: Martin AL, Halket E, Asmundson GJ, Flora DB, Katz J. Posttraumatic stress symptoms and the diathesis-stress model of chronic pain and disability in patients undergoing major surgery. Clin J Pain. 2010 Jul-Aug;26(6):518-27. doi: 10.1097/AJP.0b013e3181e15b98.
citation: Bar-El Y, Gilboa B, Unger N, Pud D, Eisenberg E. Skeletonized versus pedicled internal mammary artery: impact of surgical technique on post CABG surgery pain. Eur J Cardiothorac Surg. 2005 Jun;27(6):1065-9. doi: 10.1016/j.ejcts.2005.02.016. Epub 2005 Apr 8.
citation: Edwards PW, Zeichner A, Kuczmierczyk AR, Boczkowski J. Familial pain models: the relationship between family history of pain and current pain experience. Pain. 1985 Apr;21(4):379-384. doi: 10.1016/0304-3959(85)90166-6.
citation: Kusumi M, Araki H, Ijiri T, Kowa H, Adachi Y, Takeshima T, Sakai F, Nakashima K. Serotonin 2C receptor gene Cys23Ser polymorphism: a candidate genetic risk factor of migraine with aura in Japanese population. Acta Neurol Scand. 2004 Jun;109(6):407-9. doi: 10.1111/j.1600-0404.2004.00236.x.
citation: Borroni B, Brambilla C, Liberini P, Rao R, Archetti S, Gipponi S, Volta GD, Padovani A. Functional serotonin 5-HTTLPR polymorphism is a risk factor for migraine with aura. J Headache Pain. 2005 Sep;6(4):182-4. doi: 10.1007/s10194-005-0179-9.
citation: Guimaraes AL, de Sa AR, Victoria JM, de Fatima Correia-Silva J, Gomez MV, Gomez RS. Interleukin-1beta and serotonin transporter gene polymorphisms in burning mouth syndrome patients. J Pain. 2006 Sep;7(9):654-8. doi: 10.1016/j.jpain.2006.02.011.
citation: Camilleri M, Busciglio I, Carlson P, McKinzie S, Burton D, Baxter K, Ryks M, Zinsmeister AR. Candidate genes and sensory functions in health and irritable bowel syndrome. Am J Physiol Gastrointest Liver Physiol. 2008 Aug;295(2):G219-25. doi: 10.1152/ajpgi.90202.2008. Epub 2008 May 29.
citation: Cohen H, Buskila D, Neumann L, Ebstein RP. Confirmation of an association between fibromyalgia and serotonin transporter promoter region (5- HTTLPR) polymorphism, and relationship to anxiety-related personality traits. Arthritis Rheum. 2002 Mar;46(3):845-7. doi: 10.1002/art.10103. No abstract available.
citation: Foster DC, Sazenski TM, Stodgell CJ. Impact of genetic variation in interleukin-1 receptor antagonist and melanocortin-1 receptor genes on vulvar vestibulitis syndrome. J Reprod Med. 2004 Jul;49(7):503-9.
citation: Duerr RH, Taylor KD, Brant SR, Rioux JD, Silverberg MS, Daly MJ, Steinhart AH, Abraham C, Regueiro M, Griffiths A, Dassopoulos T, Bitton A, Yang H, Targan S, Datta LW, Kistner EO, Schumm LP, Lee AT, Gregersen PK, Barmada MM, Rotter JI, Nicolae DL, Cho JH. A genome-wide association study identifies IL23R as an inflammatory bowel disease gene. Science. 2006 Dec 1;314(5804):1461-3. doi: 10.1126/science.1135245. Epub 2006 Oct 26.
citation: Tegeder I, Costigan M, Griffin RS, Abele A, Belfer I, Schmidt H, Ehnert C, Nejim J, Marian C, Scholz J, Wu T, Allchorne A, Diatchenko L, Binshtok AM, Goldman D, Adolph J, Sama S, Atlas SJ, Carlezon WA, Parsegian A, Lotsch J, Fillingim RB, Maixner W, Geisslinger G, Max MB, Woolf CJ. GTP cyclohydrolase and tetrahydrobiopterin regulate pain sensitivity and persistence. Nat Med. 2006 Nov;12(11):1269-77. doi: 10.1038/nm1490. Epub 2006 Oct 22.
citation: Oertel B, Lotsch J. Genetic mutations that prevent pain: implications for future pain medication. Pharmacogenomics. 2008 Feb;9(2):179-94. doi: 10.2217/14622416.9.2.179.
citation: De Vries B, Haan J, Frants RR, Van den Maagdenberg AM, Ferrari MD. Genetic biomarkers for migraine. Headache. 2006 Jul-Aug;46(7):1059-68. doi: 10.1111/j.1526-4610.2006.00499.x.
citation: Reimann F, Cox JJ, Belfer I, Diatchenko L, Zaykin DV, McHale DP, Drenth JP, Dai F, Wheeler J, Sanders F, Wood L, Wu TX, Karppinen J, Nikolajsen L, Mannikko M, Max MB, Kiselycznyk C, Poddar M, Te Morsche RH, Smith S, Gibson D, Kelempisioti A, Maixner W, Gribble FM, Woods CG. Pain perception is altered by a nucleotide polymorphism in SCN9A. Proc Natl Acad Sci U S A. 2010 Mar 16;107(11):5148-53. doi: 10.1073/pnas.0913181107. Epub 2010 Mar 8.
citation: Derogatis L. SCL-90-R Administration, Scoring and Procedures Manual-II. Clinical Psychometric Research Towson, MD, 1983:14-5.
citation: Taylor S, Zvolensky MJ, Cox BJ, Deacon B, Heimberg RG, Ledley DR, Abramowitz JS, Holaway RM, Sandin B, Stewart SH, Coles M, Eng W, Daly ES, Arrindell WA, Bouvard M, Cardenas SJ. Robust dimensions of anxiety sensitivity: development and initial validation of the Anxiety Sensitivity Index-3. Psychol Assess. 2007 Jun;19(2):176-88. doi: 10.1037/1040-3590.19.2.176.
citation: Turk DC. A diathesis-stress model of chronic pain and disability following traumatic injury. Pain Res Manag. 2002 Spring;7(1):9-19. doi: 10.1155/2002/252904.
citation: McCracken LM, Dhingra L. A short version of the Pain Anxiety Symptoms Scale (PASS-20): preliminary development and validity. Pain Res Manag. 2002 Spring;7(1):45-50. doi: 10.1155/2002/517163.
citation: Leeuw M, Goossens ME, Linton SJ, Crombez G, Boersma K, Vlaeyen JW. The fear-avoidance model of musculoskeletal pain: current state of scientific evidence. J Behav Med. 2007 Feb;30(1):77-94. doi: 10.1007/s10865-006-9085-0. Epub 2006 Dec 20.
citation: Sullivan M, Bishop S, Pivik J. The Pain Catastrophizing Scale: Development and Validation. . Psychological Assessment 1995;7:524-32.
citation: Katz J, Cohen L. Preventive analgesia is associated with reduced pain disability 3 weeks but not 6 months after major gynecologic surgery by laparotomy. Anesthesiology. 2004 Jul;101(1):169-74. doi: 10.1097/00000542-200407000-00026.
citation: Costigan M, Scholz J, Woolf CJ. Neuropathic pain: a maladaptive response of the nervous system to damage. Annu Rev Neurosci. 2009;32:1-32. doi: 10.1146/annurev.neuro.051508.135531.
citation: Birklein F, Riedl B, Neundorfer B, Handwerker HO. Sympathetic vasoconstrictor reflex pattern in patients with complex regional pain syndrome. Pain. 1998 Mar;75(1):93-100. doi: 10.1016/S0304-3959(97)00209-1.
citation: Diatchenko L, Anderson AD, Slade GD, Fillingim RB, Shabalina SA, Higgins TJ, Sama S, Belfer I, Goldman D, Max MB, Weir BS, Maixner W. Three major haplotypes of the beta2 adrenergic receptor define psychological profile, blood pressure, and the risk for development of a common musculoskeletal pain disorder. Am J Med Genet B Neuropsychiatr Genet. 2006 Jul 5;141B(5):449-62. doi: 10.1002/ajmg.b.30324.
citation: Modir JG, Wallace MS. Human experimental pain models 2: the cold pressor model. Methods Mol Biol. 2010;617:165-8. doi: 10.1007/978-1-60327-323-7_13.
citation: Macrae WA. Chronic post-surgical pain: 10 years on. Br J Anaesth. 2008 Jul;101(1):77-86. doi: 10.1093/bja/aen099. Epub 2008 Apr 22.
citation: Edwards CL, Fillingim RB, Keefe F. Race, ethnicity and pain. Pain. 2001 Nov;94(2):133-137. doi: 10.1016/S0304-3959(01)00408-0.
citation: Katz J, Melzack R. Measurement of pain. Surg Clin North Am. 1999 Apr;79(2):231-52. doi: 10.1016/s0039-6109(05)70381-9.
citation: Dworkin RH, Turk DC, Revicki DA, Harding G, Coyne KS, Peirce-Sandner S, Bhagwat D, Everton D, Burke LB, Cowan P, Farrar JT, Hertz S, Max MB, Rappaport BA, Melzack R. Development and initial validation of an expanded and revised version of the Short-form McGill Pain Questionnaire (SF-MPQ-2). Pain. 2009 Jul;144(1-2):35-42. doi: 10.1016/j.pain.2009.02.007. Epub 2009 Apr 7.
citation: Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
citation: Bennett MI, Smith BH, Torrance N, Potter J. The S-LANSS score for identifying pain of predominantly neuropathic origin: validation for use in clinical and postal research. J Pain. 2005 Mar;6(3):149-58. doi: 10.1016/j.jpain.2004.11.007.
citation: Reiss S, Peterson RA, Gursky DM, McNally RJ. Anxiety sensitivity, anxiety frequency and the prediction of fearfulness. Behav Res Ther. 1986;24(1):1-8. doi: 10.1016/0005-7967(86)90143-9. No abstract available.
citation: McCracken LM, Zayfert C, Gross RT. The Pain Anxiety Symptoms Scale: development and validation of a scale to measure fear of pain. Pain. 1992 Jul;50(1):67-73. doi: 10.1016/0304-3959(92)90113-P.
citation: Pollard CA. Preliminary validity study of the pain disability index. Percept Mot Skills. 1984 Dec;59(3):974. doi: 10.2466/pms.1984.59.3.974. No abstract available.
citation: Tait RC, Pollard CA, Margolis RB, Duckro PN, Krause SJ. The Pain Disability Index: psychometric and validity data. Arch Phys Med Rehabil. 1987 Jul;68(7):438-41.
citation: Weathers F, Litz B, Huska J, Keane T. PCL-C for DSM-IV Boston: National Center for PTSD - Behavioral Science Division 1994.
citation: Blanchard EB, Jones-Alexander J, Buckley TC, Forneris CA. Psychometric properties of the PTSD Checklist (PCL). Behav Res Ther. 1996 Aug;34(8):669-73. doi: 10.1016/0005-7967(96)00033-2.
citation: Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
citation: McCracken LM, Vowles KE, Eccleston C. Acceptance of chronic pain: component analysis and a revised assessment method. Pain. 2004 Jan;107(1-2):159-66. doi: 10.1016/j.pain.2003.10.012.
citation: Vowles KE, McCracken LM, McLeod C, Eccleston C. The Chronic Pain Acceptance Questionnaire: confirmatory factor analysis and identification of patient subgroups. Pain. 2008 Nov 30;140(2):284-291. doi: 10.1016/j.pain.2008.08.012. Epub 2008 Sep 27.
citation: Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
citation: Carlson LE, Brown KW. Validation of the Mindful Attention Awareness Scale in a cancer population. J Psychosom Res. 2005 Jan;58(1):29-33. doi: 10.1016/j.jpsychores.2004.04.366.
citation: Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.
citation: Roosen K, Page MG, Kleiman V, Katz J. Sensitivity to pain traumatization scale (SPTS): Examining differences accross gender, pain history, and pain sensitivity. World Congress on Pain. Montreal, QC., 2010.
citation: Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10. doi: 10.1001/jama.286.21.2703.
citation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
citation: Cole RJ, Kripke DF, Gruen W, Mullaney DJ, Gillin JC. Automatic sleep/wake identification from wrist activity. Sleep. 1992 Oct;15(5):461-9. doi: 10.1093/sleep/15.5.461.
citation: Lichstein KL, Stone KC, Donaldson J, Nau SD, Soeffing JP, Murray D, Lester KW, Aguillard RN. Actigraphy validation with insomnia. Sleep. 2006 Feb;29(2):232-9.
citation: Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11.
citation: Bouhassira D, Kern D, Rouaud J, Pelle-Lancien E, Morain F. Investigation of the paradoxical painful sensation ('illusion of pain') produced by a thermal grill. Pain. 2005 Mar;114(1-2):160-7. doi: 10.1016/j.pain.2004.12.014. Epub 2005 Jan 20.
citation: Craig BAD. Can the basis for central neuropathic pain be identified by using a thermal grill? Pain. 2008 Apr;135(3):215-216. doi: 10.1016/j.pain.2008.01.022. Epub 2008 Feb 20. No abstract available.
citation: Rosa C, Ghione S, Mezzasalma L, Pellegrini M, Basile Fasolo C, Giaconi S, Gazzetti P, Ferdeghini M. Relationship between pain sensitivity, cardiovascular reactivity to cold pressor test and indexes of activity of the adrenergic and opioid system. Clin Exp Hypertens A. 1988;10 Suppl 1:383-90. doi: 10.3109/10641968809075994.
citation: Coffman DL, MacCallum RC. Using Parcels to Convert Path Analysis Models Into Latent Variable Models. Multivariate Behav Res. 2005 Apr 1;40(2):235-59. doi: 10.1207/s15327906mbr4002_4.
citation: Kline R. Principles and practice of structural equation modeling. 2nd ed. New York, NY: Guilford Press; 2005.
citation: Byrne B. Structural equation modeling with amos: Basic concepts, applications, and programming. Mahwah, NJ: Lawrence Erlbaum Associates; 2001.
citation: Maixner W, Diatchenko L, Fillingim RB, Greenspan J, Orbach R, Slade GD, Smith S. Assessment of biopsychosocial and genetic risk factors for chronic orofacial pain: the OPPERA Study. American Pain Society Meeting. Baltimore, Maryland, 2010.
citation: Storey JD, Tibshirani R. Statistical significance for genomewide studies. Proc Natl Acad Sci U S A. 2003 Aug 5;100(16):9440-5. doi: 10.1073/pnas.1530509100. Epub 2003 Jul 25.