Chronic PainCT-PainNCT04798573
Phenomics and Genomics of Clinically Relevant Chronic Postsurgical Pain
An observational study of Chronic Pain and Surgery, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Surgery
- How many people
- 10,000 participants
- Where
- 1 siteCanada
- Study dates
- 3 Aug 2012to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Elective cardiac and thoracic surgery patients who agree to participate in the study
Who may be able to join
- Age ≥ 18 years
- Non- Emergency Cardiac Surgery with Midline Sternotomy OR Thoracic Surgery via VATS or Lateral Thoracotomy
- Written informed consent to participate in the study
Who cannot join
- Patient unable to understand the study protocol
- History of a psychotic psychiatric disorder
- Unable to speak English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phenomics and Genomics of Clinically Relevant Chronic Postsurgical Pain: A Multicenter Prospective Study
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.
Read the 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.
- Conditions
- Chronic Pain, Surgery
- Medical subject headings
- Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Surgical Pain Intensity
Measured using the numeric rating scale (0=no pain; 10=worst pain imaginable)
Measured: 1 year from the day of surgery
Pain: Measured using the McGill Pain Questionnaire- Short Form-2 (SF-MPQ-2)
The SF-MPQ-2 is a 22-item, expanded and revised version of the SF-MPQ designed to measure the qualities of neuropathic and non-neuropathic pain. Exploratory and confirmatory factor analyses revealed the presence of the following four factors or subscales: (1) continuous pain, (2) intermittent pain, (3) neuropathic pain, and (4) affective pain descriptor.
Measured: 1 year from the day of surgery
Pain: Measured using the Self-completed Leeds Assessment of Neuropathic Symptoms and Signs (SLANSS)
The S-LANSS is a validated 7-item questionnaire designed to distinguish whether pain is predominately neuropathic or nociceptive in origin.
Measured: 1 year from the day of surgery
Anxiety: Measured using the Anxiety Sensitivity Index-3 (ASI-3)
The ASI-3 is a revised version of the widely used, 16-item scale ASI that measures concerns that anxiety and anxiety-related symptoms will lead to harmful negative consequences. Each item is rated on a 5-point scale ranging from very little (0) to very much (4).
Measured: 1 year from the day of surgery
Pain Catastrophizing: Measured using the Pain Catastrophizing Scale (PCS)
The PCS consists of 13 items describing thoughts and feelings that individuals may experience when they are in pain. Each item is rated on a 5-point scale ranging from not at all (0) to all the time (4).
Measured: 1 year from the day of surgery
Pain Anxiety: Measured using the Pain Anxiety Symptoms Scale-20 (PASS-20)
The PASS-20 is a shortened 20-item version of the original Pain Anxiety Symptoms Scale designed to measure fear and anxiety responses specific to pain, including avoidance. The PASS-20 has four 5-item subscales, including (1) cognitive anxiety, (2) escape and avoidance, (3) fearful thinking, and (4) physiological anxiety.
Measured: 1 year from the day of surgery
Pain Disability: Measured using the Pain Disability Index (PDI)
The PDI assesses the extent to which persistent pain interferes with an individual's ability to engage in seven different areas of everyday activity including: (1) family/home responsibilities, (2) recreation, (3) social activity, (4) occupation, (5) sexual behavior, (6) self-care, and (7) life-support activity.
Measured: 1 year from the day of surgery
Posttraumatic Stress Disorder: Measured using the Posttraumatic Stress Disorder Checklist-Civilian Version (PCL-C)
The Posttraumatic Stress Disorder Checklist - Civilian Version (PCL-C) is a 17-item self-report measure based on the current DSM-IV symptoms for PTSD. Respondents are asked to indicate how much they have been bothered by each symptom 5-point scale ranging from not at all (1) to extremely (5).
Measured: 1 year from the day of surgery
Anxiety and Depression: Measured using The Hospital Anxiety and Depression Scale (HADS)
The HADS is the most widely used scale for measuring symptoms of anxiety and depression among medical inpatients, outpatients and the general population and consists of 7 anxiety and 7 depression-related items.
Measured: 1 year from the day of surgery
Somatization: Measured using the SCL-90-R-Somatization
The SCL-90-R is a widely-used self-report symptom inventory measuring psychological symptoms of psychiatric and medical patients. Participants rate each item on a five-point scale of distress, ranging from 0 (no distress) to 4 (extreme distress).
Measured: 1 year from the day of surgery
Chronic Pain Acceptance: Measured using the Chronic Pain Acceptance Questionnaire (CPAQ)
The CPAQ is a 20-item questionnaire that measures how participants react and adapt to living with chronic pain. Participants respond to "how true" each item is by selecting a number from 0 ("never true") to 6 ("always true").
Measured: 1 year from the day of surgery
Mindful Attention Awareness: Measured using the Mindful Attention Awareness Scale (MAAS)
The MAAS is a 15-item scale designed to measure a central feature of dispositional mindfulness characterized by "open or receptive awareness of and attention to" the present. Participants respond to how frequently/infrequently they experience each item by selecting one of six response options on a Likert rating scale ranging from 1 ("Almost always") to 6 ("Almost never").
Measured: 1 year from the day of surgery
Pain Self Efficacy: Measured using the Pain Self-Efficacy Questionnaire (PSEQ)
The PSEQ is a 10-item Likert-type questionnaire, designed specifically for chronic pain, where patients are asked to rate their confidence to complete certain activities despite pain.
Measured: 1 year from the day of surgery
Sensitivity to Pain Traumatization: Measured using the Sensitivity to Pain Traumatization Scale (SPTS)
The SPTS is a 12-item questionnaire that was designed to measure the anxiety-related cognitive, emotional and behavioural reactions to pain that resemble symptoms of a traumatic stress reaction. Each item is rated on a 5-item Likert scale (from 1 (not at all true) to 5 (entirely true)).
Measured: 1 year from the day of surgery
Sleep Problems: Measured using the Sleep Problems Questionnaire
This is a general questionnaire that asks its questions providing responses in units of days.
Measured: 1 year from the day of surgery
Sleep Quality: Measured using the Pittsburg Sleep Quality Index (PQSI)
The PSQI questionnaire is much more specific, identifying specific responses and reasons why patients may be having trouble sleeping such as: (1) cannot get to sleep within 30 minutes and (2) wake up in the middle of the night or early morning.
Measured: 1 year from the day of surgery
Secondary outcomes (7)
Physical Activity for Thoracic Patients: Measured using Actiwatch--64
The Actiwatch-64 is a small wrist watch-like device that contains an accelerometer that records limb movements and has a memory storage capacity for up to 11 days109. The Actiwatch-64 provides a non-invasive method of collecting activity data around the clock. Activity data are downloaded to a laptop and standard sleep parameters such as latency to sleep (SOL), wake time after sleep onset (WASO), and total sleep time (TST) are inferred by software based on the presence and absence of limb movements during specified time intervals. Total activity during periods scored as not sleep is also available.
Measured: Up to 11 days from surgery
Sleep Quality for Thoracic Patients: Measured using the Sleep Quality Assessment
Each morning after surgery, up to and including the morning of discharge home from the hospital, a Sleep Diary will be completed.
Measured: Up to 11 days from surgery
Mechanical Pain Pressure: Measured using the Mechanical Pressure Pain Threshold (PPT)
Pain thresholds in response to mechanical pressure applied to the skin will be obtained using a Pressure Algometer.
Measured: 1 year from the day of surgery
Thermal Pain and Sensory: Measured using the Thermal Pain and Sensory Thresholds
Thermal stimuli will be delivered using the Medoc Thermal NeuroSensory Analyzer
Measured: 1 year from the day of surgery
Pain Illusion: Measured using the Thermal Grill Illusion Test
Participants will be required to place their right hand on four plates, two of which will be pre-cooled to 10˚C and 20˚C and two preheated to 40˚C and 50˚C. Participants will alternate between these stimuli and a grill of mixed 20˚C and 40˚C interlaced bars with 5sec intervals between applications.
Measured: 1 year from the day of surgery
Pain: Measured using the Vasoconstrictor Inspiratory Gasp
This simple test robustly activates the sympathetic system, which aggravates neuropathic pain in some chronic pain patients. Participants will be asked to rest supine on a couch and relax with eyes closed, and to take the deepest possible inspiration and then breathe normally. Three ratings of ongoing spontaneous pain will be taken at 1, 2, and 5 min after expiration. Two baseline blood pressure (systolic, diastolic and mean arterial pressure) and pulse rate measurements will be taken just before the Gasp Test and at 1 and 2 min thereafter, just after the pain ratings. Cardiovascular parameters will be carried out using an automated blood pressure cuff.
Measured: 1 year from the day of surgery
Cold Pressor Pain: Measured using the Cold Pressor Pain Test
The participant will immerse their right hand (above the elbow) in ice cold water and keep it there until they cannot tolerate the pain. The pain tolerance threshold will be recorded with a stopwatch, as the time to withdrawal; cut-off at 3 min. They will then use the NRS (0-100) to rate the magnitude of pain and unpleasantness.
Measured: 1 year from the day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start3 Aug 2012
- Primary completionDec 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (118)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hance Clarke, MD PhD FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798573
- Sponsor's protocol ID
- 12-0078
- Acronym
- CT-Pain
- Status last verified
- Jul 2025
- First submitted
- 7 Jan 2021
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20149391Wall PD, Jones M. Defeating pain: The war against a silent epidemic. New York, NY: Plenum Press; 1991.
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.
PubMed 16774458Diatchenko 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.
PubMed 15537663Katz 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.
PubMed 19402781Max 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.
PubMed 18587382Seltzer 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.
PubMed 15636014Seltzer 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.
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.
PubMed 12873949Crombie 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.
PubMed 9696470King 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.
PubMed 17161074King 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.
PubMed 17639091Lahtinen 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.
PubMed 17006079Meyerson 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.
PubMed 11576043Routledge 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.
PubMed 19269633
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenomics and Genomics of Clinically Relevant Chronic Postsurgical Pain: A Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT04798573
- Acronym / sponsor ID
- CT-Pain / 12-0078
- Conditions
- Chronic Pain, Surgery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 3 Aug 2012 (actual)
- Primary completion
- Dec 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Mar 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elective cardiac and thoracic surgery patients who agree to participate in the study
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Non- Emergency Cardiac Surgery with Midline Sternotomy OR Thoracic Surgery via VATS or Lateral Thoracotomy
- Written informed consent to participate in the study
Key exclusion criteria (3 listed)
- Patient unable to understand the study protocol
- History of a psychotic psychiatric disorder
- Unable to speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-Surgical Pain Intensity
Time frame: 1 year from the day of surgery
Measured using the numeric rating scale (0=no pain; 10=worst pain imaginable)
Pain: Measured using the McGill Pain Questionnaire- Short Form-2 (SF-MPQ-2)
Time frame: 1 year from the day of surgery
The SF-MPQ-2 is a 22-item, expanded and revised version of the SF-MPQ designed to measure the qualities of neuropathic and non-neuropathic pain. Exploratory and confirmatory factor analyses revealed the presence of the following four factors or subscales: (1) continuous pain, (2) intermittent pain, (3) neuropathic pain, and (4) affective pain descriptor.
Pain: Measured using the Self-completed Leeds Assessment of Neuropathic Symptoms and Signs (SLANSS)
Time frame: 1 year from the day of surgery
The S-LANSS is a validated 7-item questionnaire designed to distinguish whether pain is predominately neuropathic or nociceptive in origin.
Anxiety: Measured using the Anxiety Sensitivity Index-3 (ASI-3)
Time frame: 1 year from the day of surgery
The ASI-3 is a revised version of the widely used, 16-item scale ASI that measures concerns that anxiety and anxiety-related symptoms will lead to harmful negative consequences. Each item is rated on a 5-point scale ranging from very little (0) to very much (4).
Pain Catastrophizing: Measured using the Pain Catastrophizing Scale (PCS)
Time frame: 1 year from the day of surgery
The PCS consists of 13 items describing thoughts and feelings that individuals may experience when they are in pain. Each item is rated on a 5-point scale ranging from not at all (0) to all the time (4).
Pain Anxiety: Measured using the Pain Anxiety Symptoms Scale-20 (PASS-20)
Time frame: 1 year from the day of surgery
The PASS-20 is a shortened 20-item version of the original Pain Anxiety Symptoms Scale designed to measure fear and anxiety responses specific to pain, including avoidance. The PASS-20 has four 5-item subscales, including (1) cognitive anxiety, (2) escape and avoidance, (3) fearful thinking, and (4) physiological anxiety.
Pain Disability: Measured using the Pain Disability Index (PDI)
Time frame: 1 year from the day of surgery
The PDI assesses the extent to which persistent pain interferes with an individual's ability to engage in seven different areas of everyday activity including: (1) family/home responsibilities, (2) recreation, (3) social activity, (4) occupation, (5) sexual behavior, (6) self-care, and (7) life-support activity.
Posttraumatic Stress Disorder: Measured using the Posttraumatic Stress Disorder Checklist-Civilian Version (PCL-C)
Time frame: 1 year from the day of surgery
The Posttraumatic Stress Disorder Checklist - Civilian Version (PCL-C) is a 17-item self-report measure based on the current DSM-IV symptoms for PTSD. Respondents are asked to indicate how much they have been bothered by each symptom 5-point scale ranging from not at all (1) to extremely (5).
Anxiety and Depression: Measured using The Hospital Anxiety and Depression Scale (HADS)
Time frame: 1 year from the day of surgery
The HADS is the most widely used scale for measuring symptoms of anxiety and depression among medical inpatients, outpatients and the general population and consists of 7 anxiety and 7 depression-related items.
Somatization: Measured using the SCL-90-R-Somatization
Time frame: 1 year from the day of surgery
The SCL-90-R is a widely-used self-report symptom inventory measuring psychological symptoms of psychiatric and medical patients. Participants rate each item on a five-point scale of distress, ranging from 0 (no distress) to 4 (extreme distress).
Chronic Pain Acceptance: Measured using the Chronic Pain Acceptance Questionnaire (CPAQ)
Time frame: 1 year from the day of surgery
The CPAQ is a 20-item questionnaire that measures how participants react and adapt to living with chronic pain. Participants respond to "how true" each item is by selecting a number from 0 ("never true") to 6 ("always true").
Mindful Attention Awareness: Measured using the Mindful Attention Awareness Scale (MAAS)
Time frame: 1 year from the day of surgery
The MAAS is a 15-item scale designed to measure a central feature of dispositional mindfulness characterized by "open or receptive awareness of and attention to" the present. Participants respond to how frequently/infrequently they experience each item by selecting one of six response options on a Likert rating scale ranging from 1 ("Almost always") to 6 ("Almost never").
Pain Self Efficacy: Measured using the Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: 1 year from the day of surgery
The PSEQ is a 10-item Likert-type questionnaire, designed specifically for chronic pain, where patients are asked to rate their confidence to complete certain activities despite pain.
Sensitivity to Pain Traumatization: Measured using the Sensitivity to Pain Traumatization Scale (SPTS)
Time frame: 1 year from the day of surgery
The SPTS is a 12-item questionnaire that was designed to measure the anxiety-related cognitive, emotional and behavioural reactions to pain that resemble symptoms of a traumatic stress reaction. Each item is rated on a 5-item Likert scale (from 1 (not at all true) to 5 (entirely true)).
Sleep Problems: Measured using the Sleep Problems Questionnaire
Time frame: 1 year from the day of surgery
This is a general questionnaire that asks its questions providing responses in units of days.
Sleep Quality: Measured using the Pittsburg Sleep Quality Index (PQSI)
Time frame: 1 year from the day of surgery
The PSQI questionnaire is much more specific, identifying specific responses and reasons why patients may be having trouble sleeping such as: (1) cannot get to sleep within 30 minutes and (2) wake up in the middle of the night or early morning.
7 secondary outcomes
Physical Activity for Thoracic Patients: Measured using Actiwatch--64
Time frame: Up to 11 days from surgery
Sleep Quality for Thoracic Patients: Measured using the Sleep Quality Assessment
Time frame: Up to 11 days from surgery
Mechanical Pain Pressure: Measured using the Mechanical Pressure Pain Threshold (PPT)
Time frame: 1 year from the day of surgery
Thermal Pain and Sensory: Measured using the Thermal Pain and Sensory Thresholds
Time frame: 1 year from the day of surgery
Pain Illusion: Measured using the Thermal Grill Illusion Test
Time frame: 1 year from the day of surgery
Pain: Measured using the Vasoconstrictor Inspiratory Gasp
Time frame: 1 year from the day of surgery
Cold Pressor Pain: Measured using the Cold Pressor Pain Test
Time frame: 1 year from the day of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Background: PubMed 20149391Ohayon 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.
- BackgroundWall PD, Jones M. Defeating pain: The war against a silent epidemic. New York, NY: Plenum Press; 1991.
- Background: PubMed 16774458McCarberg 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.
- Background: PubMed 15537663Diatchenko 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.
- Background: PubMed 19402781Katz 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.
- Background: PubMed 18587382Max 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.
- Background: PubMed 15636014Seltzer 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.
- BackgroundSeltzer 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.
- Background: PubMed 12873949Apfelbaum 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.
- Background: PubMed 9696470Crombie 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.
- Background: PubMed 17161074King 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.
- Background: PubMed 17639091King 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.
- Individual participant dataSharing planned: No
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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.
Hance Clarke, MD PhD FRCPC principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Surgery, run by University Health Network, Toronto at 1 site in Canada.
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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Post-Surgical Pain Intensity (time frame: 1 year from the day of surgery). 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 NCT04798573, which also lists 118 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 8 Jul 2025.