Adolescent Idiopathic ScoliosisNCT04244760
Pain Assessment in Children Undergoing Spine Surgery
A study testing Pain assessment for verbal patients and Pain assessment for non-verbal patients in people with Adolescent Idiopathic Scoliosis and Cerebral Palsy, run by Catherine Ferland at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis, Cerebral Palsy
- What is being tested?
- Pain assessment for verbal patients and Pain assessment for non-verbal patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Adolescent Idiopathic Scoliosis, Cerebral Palsy
- Being tested
- Pain assessment for verbal patients, Pain assessment for non-verbal patients
- Keywords
- Adolescent Idiopathic Scoliosis, Cerebral Palsy, Conditioned Pain Modulation, Chronic Postsurgical Pain, Quantitative Sensory Testing, Pain Management
- Medical subject headings
- Cerebral Palsy, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain assessment for verbal patientsBehavioural
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.
Pain assessment for non-verbal patientsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Verbal Patients | Active comparator | Not described Receives: Behavioral: Pain assessment for verbal patients |
| Non-verbal Patients | Active comparator | Not described Receives: Behavioral: Pain assessment for non-verbal patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Measured: Baseline
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2 years postoperative
Secondary outcomes (68)
Mechanical detection threshold (grams) as measured with von Frey filaments
Measured: Baseline
Pain pressure threshold (Newtons) as measured with an algometer.
Measured: 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.
Measured: Baseline
Mechanical detection threshold (grams) as measured with von Frey filaments
Measured: Postoperative day 1
Pain pressure threshold (Newtons) as measured with an algometer.
Measured: Postoperative day 1
Mechanical detection threshold (grams) as measured with von Frey filaments
Measured: Postoperative day 2
Pain pressure threshold (Newtons) as measured with an algometer.
Measured: Postoperative day 2
Mechanical detection threshold (grams) as measured with von Frey filaments
Measured: Postoperative day 5
Pain pressure threshold (Newtons) as measured with an algometer.
Measured: 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.
Measured: Postoperative day 5
Mechanical detection threshold (grams) as measured with von Frey filaments
Measured: 6 weeks postoperative
Pain pressure threshold (Newtons) as measured with an algometer.
Measured: 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.
Measured: 6 weeks postoperative
Mechanical detection threshold (grams) as measured with von Frey filaments
Measured: 6 months postoperative
Pain pressure threshold (Newtons) as measured with an algometer.
Measured: 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.
Measured: 6 months postoperative
Mechanical detection threshold (grams) as measured with von Frey filaments
Measured: 1 year postoperative
Pain pressure threshold (Newtons) as measured with an algometer.
Measured: 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.
Measured: 1 year postoperative
Mechanical detection threshold (grams) as measured with von Frey filaments
Measured: 2 years postoperative
Pain pressure threshold (Newtons) as measured with an algometer.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study startJan 2015
- Primary completionJan 2022
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catherine Ferland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Catherine Ferland, Shriners Hospitals for Children
- Investigators
- Catherine Ferland, Principal investigator, Shriners Hospitals for Children,Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244760
- Sponsor's protocol ID
- A08M7114B
- Status last verified
- May 2022
- First submitted
- 10 Jan 2020
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-operative Pain Assessment in Children Undergoing Orthopaedic Surgery
- ClinicalTrials.gov ID
- NCT04244760
- Acronym / sponsor ID
- A08M7114B
- Conditions
- Adolescent Idiopathic Scoliosis, Cerebral Palsy
- Keywords
- Adolescent Idiopathic Scoliosis, Cerebral Palsy, Conditioned Pain Modulation, Chronic Postsurgical Pain, Quantitative Sensory Testing, Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Catherine FerlandUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2022 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verbal Patients | Active comparator | Behavioral: Pain assessment for verbal patients |
| Non-verbal Patients | Active comparator | Behavioral: Pain assessment for non-verbal patients |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain assessment for verbal patientsThe 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. | Behavioural | Verbal Patients |
| Pain assessment for non-verbal patientsThe 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. | Behavioural | Non-verbal Patients |
Primary outcome
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
68 secondary outcomes
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.
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.
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.
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.
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.
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.
Time frame: 2 years postoperative
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Time frame: Baseline
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Time frame: Postoperative day 1
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Time frame: Postoperative day 2
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Time frame: Postoperative day 5
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Time frame: 6 weeks postoperative
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Time frame: 6 months postoperative
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
Time frame: 1 year postoperative
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.
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).
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).
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).
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).
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).
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.
Time frame: Baseline
Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.
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.
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.
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.
Time frame: 2 years postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Ferland principal investigator
Shriners Hospitals for Children,Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain assessment for verbal patients and Pain assessment for non-verbal patients in people with Adolescent Idiopathic Scoliosis and Cerebral Palsy, run by Catherine Ferland at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.