Pain Assessment in Children Undergoing Spine Surgery

Peri-operative Pain Assessment in Children Undergoing Orthopaedic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Behavioral: Pain assessment for verbal patients; Behavioral: Pain assessment for non-verbal patients

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.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H4A0A9
      • Shriners Hospital for Children-Canada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Verbal Patients	Behavioral: Pain assessment for verbal patients; 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.
Active Comparator: Non-verbal Patients	Behavioral: Pain assessment for non-verbal patients; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients	Baseline
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients	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	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	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	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	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	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	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	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	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	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	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	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	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	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	2 years postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical detection threshold (grams) as measured with von Frey filaments		Baseline
Pain pressure threshold (Newtons) as measured with an algometer.		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.	Baseline
Mechanical detection threshold (grams) as measured with von Frey filaments		Postoperative day 1
Pain pressure threshold (Newtons) as measured with an algometer.		Postoperative day 1
Mechanical detection threshold (grams) as measured with von Frey filaments		Postoperative day 2
Pain pressure threshold (Newtons) as measured with an algometer.		Postoperative day 2
Mechanical detection threshold (grams) as measured with von Frey filaments		Postoperative day 5
Pain pressure threshold (Newtons) as measured with an algometer.		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.	Postoperative day 5
Mechanical detection threshold (grams) as measured with von Frey filaments		6 weeks postoperative
Pain pressure threshold (Newtons) as measured with an algometer.		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.	6 weeks postoperative
Mechanical detection threshold (grams) as measured with von Frey filaments		6 months postoperative
Pain pressure threshold (Newtons) as measured with an algometer.		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.	6 months postoperative
Mechanical detection threshold (grams) as measured with von Frey filaments		1 year postoperative
Pain pressure threshold (Newtons) as measured with an algometer.		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.	1 year postoperative
Mechanical detection threshold (grams) as measured with von Frey filaments		2 years postoperative
Pain pressure threshold (Newtons) as measured with an algometer.		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.	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.	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.	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.	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.	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.	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.	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.	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.	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)	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)	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)	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)	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)	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	2 years postoperative

Collaborators and Investigators

• Sponsor: Catherine Ferland
• Investigators: Principal Investigator: Catherine Ferland, Shriners Hospitals for Children,Canada

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: January 10, 2020
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Quantitative Sensory Testing; Pain Management; Adolescent Idiopathic Scoliosis; Chronic Postsurgical Pain; Conditioned Pain Modulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Cerebral Palsy; Scoliosis
• Other Study ID Numbers: A08M7114B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No