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Pain Assessment in Children Undergoing Spine Surgery

Primary Purpose

Adolescent Idiopathic Scoliosis, Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pain assessment for verbal patients
Pain assessment for non-verbal patients
Sponsored by
Catherine Ferland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring Adolescent Idiopathic Scoliosis, Cerebral Palsy, Conditioned Pain Modulation, Chronic Postsurgical Pain, Quantitative Sensory Testing, Pain Management

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Shriners Hospital for Children-Canada

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Verbal Patients

Non-verbal Patients

Arm Description

Outcomes

Primary Outcome Measures

Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
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
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
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
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
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
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
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
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

Secondary Outcome Measures

Mechanical detection threshold (grams) as measured with von Frey filaments
Pain pressure threshold (Newtons) as measured with an algometer.
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.
Mechanical detection threshold (grams) as measured with von Frey filaments
Pain pressure threshold (Newtons) as measured with an algometer.
Mechanical detection threshold (grams) as measured with von Frey filaments
Pain pressure threshold (Newtons) as measured with an algometer.
Mechanical detection threshold (grams) as measured with von Frey filaments
Pain pressure threshold (Newtons) as measured with an algometer.
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.
Mechanical detection threshold (grams) as measured with von Frey filaments
Pain pressure threshold (Newtons) as measured with an algometer.
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.
Mechanical detection threshold (grams) as measured with von Frey filaments
Pain pressure threshold (Newtons) as measured with an algometer.
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.
Mechanical detection threshold (grams) as measured with von Frey filaments
Pain pressure threshold (Newtons) as measured with an algometer.
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.
Mechanical detection threshold (grams) as measured with von Frey filaments
Pain pressure threshold (Newtons) as measured with an algometer.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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)
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)
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)
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)
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 10, 2020
Last Updated
May 3, 2022
Sponsor
Catherine Ferland
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1. Study Identification

Unique Protocol Identification Number
NCT04244760
Brief Title
Pain Assessment in Children Undergoing Spine Surgery
Official Title
Peri-operative Pain Assessment in Children Undergoing Orthopaedic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
January 2022 (Actual)
Study Completion Date
March 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Catherine Ferland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis, Cerebral Palsy
Keywords
Adolescent Idiopathic Scoliosis, Cerebral Palsy, Conditioned Pain Modulation, Chronic Postsurgical Pain, Quantitative Sensory Testing, Pain Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verbal Patients
Arm Type
Active Comparator
Arm Title
Non-verbal Patients
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Pain assessment for verbal patients
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pain assessment for non-verbal patients
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Mechanical detection threshold (grams) as measured with von Frey filaments
Time Frame
Baseline
Title
Pain pressure threshold (Newtons) as measured with an algometer.
Time Frame
Baseline
Title
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.
Description
Conditioned pain modulation measurement is omitted in the non-verbal patient arm.
Time Frame
Baseline
Title
Mechanical detection threshold (grams) as measured with von Frey filaments
Time Frame
Postoperative day 1
Title
Pain pressure threshold (Newtons) as measured with an algometer.
Time Frame
Postoperative day 1
Title
Mechanical detection threshold (grams) as measured with von Frey filaments
Time Frame
Postoperative day 2
Title
Pain pressure threshold (Newtons) as measured with an algometer.
Time Frame
Postoperative day 2
Title
Mechanical detection threshold (grams) as measured with von Frey filaments
Time Frame
Postoperative day 5
Title
Pain pressure threshold (Newtons) as measured with an algometer.
Time Frame
Postoperative day 5
Title
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.
Description
Conditioned pain modulation measurement is omitted in the non-verbal patient arm.
Time Frame
Postoperative day 5
Title
Mechanical detection threshold (grams) as measured with von Frey filaments
Time Frame
6 weeks postoperative
Title
Pain pressure threshold (Newtons) as measured with an algometer.
Time Frame
6 weeks postoperative
Title
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.
Description
Conditioned pain modulation measurement is omitted in the non-verbal patient arm.
Time Frame
6 weeks postoperative
Title
Mechanical detection threshold (grams) as measured with von Frey filaments
Time Frame
6 months postoperative
Title
Pain pressure threshold (Newtons) as measured with an algometer.
Time Frame
6 months postoperative
Title
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.
Description
Conditioned pain modulation measurement is omitted in the non-verbal patient arm.
Time Frame
6 months postoperative
Title
Mechanical detection threshold (grams) as measured with von Frey filaments
Time Frame
1 year postoperative
Title
Pain pressure threshold (Newtons) as measured with an algometer.
Time Frame
1 year postoperative
Title
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.
Description
Conditioned pain modulation measurement is omitted in the non-verbal patient arm.
Time Frame
1 year postoperative
Title
Mechanical detection threshold (grams) as measured with von Frey filaments
Time Frame
2 years postoperative
Title
Pain pressure threshold (Newtons) as measured with an algometer.
Time Frame
2 years postoperative
Title
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.
Description
Conditioned pain modulation measurement is omitted in the non-verbal patient arm.
Time Frame
2 years postoperative
Title
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
Baseline
Title
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
Postoperative day 1
Title
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
Postoperative day 2
Title
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
Postoperative day 5
Title
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
6 weeks postoperative
Title
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
6 months postoperative
Title
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
1 year postoperative
Title
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
2 years postoperative
Title
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).
Description
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
Title
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).
Description
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
Title
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).
Description
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
Title
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).
Description
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
Title
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).
Description
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
Title
Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
Baseline
Title
Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
6 weeks postoperative
Title
Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
6 months postoperative
Title
Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
1 year postoperative
Title
Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
2 years postoperative
Title
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
Baseline
Title
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
Baseline
Title
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
Day of surgery
Title
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
Day of surgery
Title
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
6 weeks postoperative
Title
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
6 weeks postoperative
Title
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
6 months postoperative
Title
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
6 months postoperative
Title
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
1 year postoperative
Title
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
1 year postoperative
Title
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
2 years postoperative
Title
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
2 years postoperative
Title
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
Baseline
Title
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
Postoperative day 1
Title
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
Postoperative day 2
Title
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
Postoperative day 5
Title
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
6 weeks postoperative
Title
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
6 months postoperative
Title
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
1 year postoperative
Title
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
2 years postoperative
Title
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
Baseline
Title
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
Postoperative day 1
Title
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
Postoperative day 2
Title
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
Postoperative day 5
Title
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
6 weeks postoperative
Title
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
6 months postoperative
Title
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
1 year postoperative
Title
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").
Description
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.
Time Frame
2 years postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Ferland
Organizational Affiliation
Shriners Hospitals for Children,Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shriners Hospital for Children-Canada
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A0A9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pain Assessment in Children Undergoing Spine Surgery

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