Musculoskeletal (MSK) pain is one of the most common types of pain among children and adolescents. Recurring episodes of MSK pain conditions have a major impact on the daily lives. Children and adolescents with neuromuscular diseases are often unable to report the pain the patients experience because of intellectual and/or physical limitations. There is no reason to believe that pain is any less frequent or intense in these patients than in normally developing patients. Because of the elusive nature of pain in non-verbal children, therapeutic decisions are frequently based on vague proxy measures of pain and revert to a series of trials and errors. This project creates a unique opportunity to directly characterize and compare MSK and surgical pain subjectively in two different patient samples (verbal and non-verbal). The ultimate goal is to use this information to offer the highest quality of pain control in children with MSK conditions, and more specifically in children with limited communication skills unable to communicate their distress associated with the surgical procedural.
Improvement in the assessment techniques, to enable better pain management in children with intellectual and developmental disabilities who are unable to describe the intensity of the postsurgical pain, is a cornerstone of our research program. This research project will elucidate the regulation of specific markers of global surgical insult (nociception, inflammation, stress responses) associated to specific physiological mechanisms related to pain in children with and without verbal skills undergoing major orthopaedic surgery. This project creates a unique opportunity to directly characterize and compare MSK and surgical pain subjectively in the two different patient samples (verbal and non-verbal). As molecular events of pathophysiological processes are quantifiable, the investigators will test for associations between the expression of front-running pain biomarkers in physiological fluids (blood and saliva) and the experience of pain in two patient samples (verbal and non-verbal) undergoing major orthopaedic surgery. The identification of biomarkers will provide a deeper understanding of a patient's pain perception alongside self-report or observers' report subjective measurements. Even with standardization of best practice perioperative anesthetic pain management, children undergoing similar surgical procedures experience pain at different intensity. Based on preliminary findings, treatment modalities appear to be ineffective in one out of five patients. Pain experience variability may originate in the lack of rigor in the clinical pain assessment tools. Tools such as numerical rating scales used in the perioperative period are not based on objective patient specific pain thresholds. A personalized mechanism-based approach may be the key to better identify a patient's postsurgical pain outcome and how this assessment could lead to personalized perioperative pain management. The ultimate goal is to use this information to offer the highest quality of pain control in children with MSK conditions, and more specifically in children with limited communication skills unable to communicate their distress associated with the surgical procedures.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
The pain profile of the patient will be assessed at each time point including biological sample analysis (blood and saliva), quantitative sensory testing (mechanical and thermal), and psychological state via the completion of questionnaires by the patient.
The pain profile of the patient will be assessed at each time point including biological sample analysis (blood and saliva), quantitative sensory testing (mechanical), and psychological state via the completion of questionnaires by the parent of the patient.
Shriners Hospital for Children-Canada
Montreal, Quebec, Canada
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Time frame: Baseline
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Time frame: Postoperative day 1
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Time frame: Postoperative day 2
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Time frame: Postoperative day 5
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Time frame: 6 weeks postoperative
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Time frame: 6 months postoperative
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Time frame: 1 year postoperative
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Time frame: 2 years postoperative
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain
Time frame: Baseline
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain
Time frame: Postoperative day 1
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain
Time frame: Postoperative day 2
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain
Time frame: Postoperative day 5
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain
Time frame: 6 weeks postoperative
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain
Time frame: 6 months postoperative
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain
Time frame: 1 year postoperative
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain
Time frame: 2 years postoperative
Mechanical detection threshold (grams) as measured with von Frey filaments
Time frame: Baseline
Pain pressure threshold (Newtons) as measured with an algometer.
Time frame: Baseline
Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test.
Conditioned pain modulation measurement is omitted in the non-verbal patient arm.
Time frame: Baseline
Mechanical detection threshold (grams) as measured with von Frey filaments
Time frame: Postoperative day 1
Pain pressure threshold (Newtons) as measured with an algometer.
Time frame: Postoperative day 1
Mechanical detection threshold (grams) as measured with von Frey filaments
Time frame: Postoperative day 2
Pain pressure threshold (Newtons) as measured with an algometer.
Time frame: Postoperative day 2
Mechanical detection threshold (grams) as measured with von Frey filaments
Time frame: Postoperative day 5
Pain pressure threshold (Newtons) as measured with an algometer.
Time frame: Postoperative day 5
Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test.
Conditioned pain modulation measurement is omitted in the non-verbal patient arm.
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Time frame: Postoperative day 5
Mechanical detection threshold (grams) as measured with von Frey filaments
Time frame: 6 weeks postoperative
Pain pressure threshold (Newtons) as measured with an algometer.
Time frame: 6 weeks postoperative
Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test.
Conditioned pain modulation measurement is omitted in the non-verbal patient arm.
Time frame: 6 weeks postoperative
Mechanical detection threshold (grams) as measured with von Frey filaments
Time frame: 6 months postoperative
Pain pressure threshold (Newtons) as measured with an algometer.
Time frame: 6 months postoperative
Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test.
Conditioned pain modulation measurement is omitted in the non-verbal patient arm.
Time frame: 6 months postoperative
Mechanical detection threshold (grams) as measured with von Frey filaments
Time frame: 1 year postoperative
Pain pressure threshold (Newtons) as measured with an algometer.
Time frame: 1 year postoperative
Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test.
Conditioned pain modulation measurement is omitted in the non-verbal patient arm.
Time frame: 1 year postoperative
Mechanical detection threshold (grams) as measured with von Frey filaments
Time frame: 2 years postoperative
Pain pressure threshold (Newtons) as measured with an algometer.
Time frame: 2 years postoperative
Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test.
Conditioned pain modulation measurement is omitted in the non-verbal patient arm.
Time frame: 2 years postoperative
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: Baseline
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: Postoperative day 1
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: Postoperative day 2
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: Postoperative day 5
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 6 weeks postoperative
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 6 months postoperative
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 1 year postoperative
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 2 years postoperative
Total score (30-150) across to 4 domains of the Scoliosis Research Society Questionnaire-30 (SRS-30) regarding the outcome of the patient's spine surgery (items scored from 1=worst, to 5=best, thus lower scores mean worse outcomes).
4 domains: 1) pain (max. score 30) 2) mental health (max. score 25) 3) function/activity (max. score 35) 4) Self Image/appearance (max. score 45)
Time frame: Baseline
Total score (30-150) across to 4 domains of the Scoliosis Research Society Questionnaire-30 (SRS-30) regarding the outcome of the patient's spine surgery (items scored from 1=worst, to 5=best, thus lower scores mean worse outcomes).
4 domains: 1) pain (max. score 30) 2) mental health (max. score 25) 3) function/activity (max. score 35) 4) Self Image/appearance (max. score 45)
Time frame: 6 weeks postoperative
Total score (30-150) across to 4 domains of the Scoliosis Research Society Questionnaire-30 (SRS-30) regarding the outcome of the patient's spine surgery (items scored from 1=worst, to 5=best, thus lower scores mean worse outcomes).
4 domains: 1) pain (max. score 30) 2) mental health (max. score 25) 3) function/activity (max. score 35) 4) Self Image/appearance (max. score 45)
Time frame: 6 months postoperative
Total score (30-150) across to 4 domains of the Scoliosis Research Society Questionnaire-30 (SRS-30) regarding the outcome of the patient's spine surgery (items scored from 1=worst, to 5=best, thus lower scores mean worse outcomes).
4 domains: 1) pain (max. score 30) 2) mental health (max. score 25) 3) function/activity (max. score 35) 4) Self Image/appearance (max. score 45)
Time frame: 1 year postoperative
Total score (30-150) across to 4 domains of the Scoliosis Research Society Questionnaire-30 (SRS-30) regarding the outcome of the patient's spine surgery (items scored from 1=worst, to 5=best, thus lower scores mean worse outcomes).
4 domains: 1) pain (max. score 30) 2) mental health (max. score 25) 3) function/activity (max. score 35) 4) Self Image/appearance (max. score 45)
Time frame: 2 years postoperative
Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: Baseline
Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 6 weeks postoperative
Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 6 months postoperative
Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 1 year postoperative
Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 2 years postoperative
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: Baseline
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: Baseline
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: Day of surgery
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: Day of surgery
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 6 weeks postoperative
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 6 weeks postoperative
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 6 months postoperative
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 6 months postoperative
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 1 year postoperative
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 1 year postoperative
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 2 years postoperative
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 2 years postoperative
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: Baseline
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: Postoperative day 1
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: Postoperative day 2
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: Postoperative day 5
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 6 weeks postoperative
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 6 months postoperative
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 1 year postoperative
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 2 years postoperative
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: Baseline
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: Postoperative day 1
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: Postoperative day 2
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: Postoperative day 5
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 6 weeks postoperative
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 6 months postoperative
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 1 year postoperative
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time frame: 2 years postoperative