Clinical trial NCT04244760: Pain Assessment in Children Undergoing Spine Surgery
Official title: Peri-operative Pain Assessment in Children Undergoing Orthopaedic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Cerebral Palsy
Keywords: Adolescent Idiopathic Scoliosis
Cerebral Palsy
Conditioned Pain Modulation
Chronic Postsurgical Pain
Quantitative Sensory Testing
Pain Management
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 240
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Aged between 10 and 21 years old
* Scheduled to undergo posterior or anterior spinal fusion surgery for AIS with instrumentation
* Ability to adequately understand and respond to outcome measures
* No previous major orthopedic surgery
* Female or male
* Any ethnic background

Exclusion Criteria:

* Inability of the child to speak English or French
* Diagnosed with developmental delay that would interfere with understanding questions being asked (autism, mental retardation)
* Children with major chronic medical conditions (ASA status III or higher)

Primary outcomes:
measure: Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
timeFrame: Baseline
measure: Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
timeFrame: Postoperative day 1
measure: Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
timeFrame: Postoperative day 2
measure: Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
timeFrame: Postoperative day 5
measure: Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
timeFrame: 6 weeks postoperative
measure: Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
timeFrame: 6 months postoperative
measure: Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
timeFrame: 1 year postoperative
measure: Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
timeFrame: 2 years postoperative
measure: 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
timeFrame: Baseline
measure: 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
timeFrame: Postoperative day 1
measure: 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
timeFrame: Postoperative day 2
measure: 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
timeFrame: Postoperative day 5
measure: 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
timeFrame: 6 weeks postoperative
measure: 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
timeFrame: 6 months postoperative
measure: 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
timeFrame: 1 year postoperative
measure: 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
timeFrame: 2 years postoperative
Secondary outcomes:
measure: Mechanical detection threshold (grams) as measured with von Frey filaments
timeFrame: Baseline
measure: Pain pressure threshold (Newtons) as measured with an algometer.
timeFrame: Baseline
measure: 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.
timeFrame: Baseline
measure: Mechanical detection threshold (grams) as measured with von Frey filaments
timeFrame: Postoperative day 1
measure: Pain pressure threshold (Newtons) as measured with an algometer.
timeFrame: Postoperative day 1
measure: Mechanical detection threshold (grams) as measured with von Frey filaments
timeFrame: Postoperative day 2
measure: Pain pressure threshold (Newtons) as measured with an algometer.
timeFrame: Postoperative day 2
measure: Mechanical detection threshold (grams) as measured with von Frey filaments
timeFrame: Postoperative day 5
measure: Pain pressure threshold (Newtons) as measured with an algometer.
timeFrame: Postoperative day 5
measure: 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.
timeFrame: Postoperative day 5
measure: Mechanical detection threshold (grams) as measured with von Frey filaments
timeFrame: 6 weeks postoperative
measure: Pain pressure threshold (Newtons) as measured with an algometer.
timeFrame: 6 weeks postoperative
measure: 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.
timeFrame: 6 weeks postoperative
measure: Mechanical detection threshold (grams) as measured with von Frey filaments
timeFrame: 6 months postoperative
measure: Pain pressure threshold (Newtons) as measured with an algometer.
timeFrame: 6 months postoperative
measure: 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.
timeFrame: 6 months postoperative
measure: Mechanical detection threshold (grams) as measured with von Frey filaments
timeFrame: 1 year postoperative
measure: Pain pressure threshold (Newtons) as measured with an algometer.
timeFrame: 1 year postoperative
measure: 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.
timeFrame: 1 year postoperative
measure: Mechanical detection threshold (grams) as measured with von Frey filaments
timeFrame: 2 years postoperative
measure: Pain pressure threshold (Newtons) as measured with an algometer.
timeFrame: 2 years postoperative
measure: 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.
timeFrame: 2 years postoperative
measure: Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
timeFrame: Baseline
measure: Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
timeFrame: Postoperative day 1
measure: Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
timeFrame: Postoperative day 2
measure: Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
timeFrame: Postoperative day 5
measure: Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
timeFrame: 6 weeks postoperative
measure: Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
timeFrame: 6 months postoperative
measure: Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
timeFrame: 1 year postoperative
measure: Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
timeFrame: 2 years postoperative
measure: 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).
timeFrame: Baseline
measure: 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).
timeFrame: 6 weeks postoperative
measure: 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).
timeFrame: 6 months postoperative
measure: 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).
timeFrame: 1 year postoperative
measure: 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).
timeFrame: 2 years postoperative
measure: Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
timeFrame: Baseline
measure: Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
timeFrame: 6 weeks postoperative
measure: Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
timeFrame: 6 months postoperative
measure: Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
timeFrame: 1 year postoperative
measure: Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
timeFrame: 2 years postoperative
measure: Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
timeFrame: Baseline
measure: Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
timeFrame: Baseline
measure: Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
timeFrame: Day of surgery
measure: Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
timeFrame: Day of surgery
measure: Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
timeFrame: 6 weeks postoperative
measure: Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
timeFrame: 6 weeks postoperative
measure: Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
timeFrame: 6 months postoperative
measure: Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
timeFrame: 6 months postoperative
measure: Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
timeFrame: 1 year postoperative
measure: Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
timeFrame: 1 year postoperative
measure: Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
timeFrame: 2 years postoperative
measure: Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
timeFrame: 2 years postoperative
measure: Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
timeFrame: Baseline
measure: Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
timeFrame: Postoperative day 1
measure: Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
timeFrame: Postoperative day 2
measure: Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
timeFrame: Postoperative day 5
measure: Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
timeFrame: 6 weeks postoperative
measure: Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
timeFrame: 6 months postoperative
measure: Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
timeFrame: 1 year postoperative
measure: Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
timeFrame: 2 years postoperative
measure: Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
timeFrame: Baseline
measure: Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
timeFrame: Postoperative day 1
measure: Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
timeFrame: Postoperative day 2
measure: Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
timeFrame: Postoperative day 5
measure: Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
timeFrame: 6 weeks postoperative
measure: Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
timeFrame: 6 months postoperative
measure: Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
timeFrame: 1 year postoperative
measure: Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
timeFrame: 2 years postoperative
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Shriners Hospital for Children-Canada
state: Quebec
Study officials:
affiliation: Shriners Hospitals for Children,Canada
name: Catherine Ferland
role: PRINCIPAL_INVESTIGATOR
References: