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NCT Number: NCT04244760

Pain Assessment in Children Undergoing Spine 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.

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Key information

Conditions

Adolescent Idiopathic Scoliosis Agnosia Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shriners Hospital for Children-Canada

Montreal, Quebec, H4A0A9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pain assessment for verbal patients

Behavioral

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 patients

Behavioral

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 outcomes

  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: Baseline

  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 1

  3. 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

  4. 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

  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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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 outcomes

  1. Mechanical detection threshold (grams) as measured with von Frey filaments

    Time frame: Baseline

  2. Pain pressure threshold (Newtons) as measured with an algometer.

    Time frame: Baseline

  3. 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

    Conditioned pain modulation measurement is omitted in the non-verbal patient arm.

  4. Mechanical detection threshold (grams) as measured with von Frey filaments

    Time frame: Postoperative day 1

  5. Pain pressure threshold (Newtons) as measured with an algometer.

    Time frame: Postoperative day 1

  6. Mechanical detection threshold (grams) as measured with von Frey filaments

    Time frame: Postoperative day 2

  7. Pain pressure threshold (Newtons) as measured with an algometer.

    Time frame: Postoperative day 2

  8. Mechanical detection threshold (grams) as measured with von Frey filaments

    Time frame: Postoperative day 5

  9. Pain pressure threshold (Newtons) as measured with an algometer.

    Time frame: Postoperative day 5

  10. 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

    Conditioned pain modulation measurement is omitted in the non-verbal patient arm.

  11. Mechanical detection threshold (grams) as measured with von Frey filaments

    Time frame: 6 weeks postoperative

  12. Pain pressure threshold (Newtons) as measured with an algometer.

    Time frame: 6 weeks postoperative

  13. 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

    Conditioned pain modulation measurement is omitted in the non-verbal patient arm.

  14. Mechanical detection threshold (grams) as measured with von Frey filaments

    Time frame: 6 months postoperative

  15. Pain pressure threshold (Newtons) as measured with an algometer.

    Time frame: 6 months postoperative

  16. 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

    Conditioned pain modulation measurement is omitted in the non-verbal patient arm.

  17. Mechanical detection threshold (grams) as measured with von Frey filaments

    Time frame: 1 year postoperative

  18. Pain pressure threshold (Newtons) as measured with an algometer.

    Time frame: 1 year postoperative

  19. 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

    Conditioned pain modulation measurement is omitted in the non-verbal patient arm.

  20. Mechanical detection threshold (grams) as measured with von Frey filaments

    Time frame: 2 years postoperative

  21. Pain pressure threshold (Newtons) as measured with an algometer.

    Time frame: 2 years postoperative

  22. 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

    Conditioned pain modulation measurement is omitted in the non-verbal patient arm.

  23. Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.

    Time frame: Baseline

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  24. Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.

    Time frame: Postoperative day 1

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  25. Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.

    Time frame: Postoperative day 2

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  26. Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.

    Time frame: Postoperative day 5

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  27. Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.

    Time frame: 6 weeks postoperative

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  28. Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.

    Time frame: 6 months postoperative

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  29. Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.

    Time frame: 1 year postoperative

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  30. Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety.

    Time frame: 2 years postoperative

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  31. 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

    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)

  32. 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

    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)

  33. 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

    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)

  34. 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

    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)

  35. 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

    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)

  36. Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks.

    Time frame: Baseline

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  37. 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

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  38. 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

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  39. 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

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  40. 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

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  41. Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.

    Time frame: Baseline

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  42. Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.

    Time frame: Baseline

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  43. Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.

    Time frame: Day of surgery

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  44. Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.

    Time frame: Day of surgery

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  45. Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.

    Time frame: 6 weeks postoperative

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  46. Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.

    Time frame: 6 weeks postoperative

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  47. Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.

    Time frame: 6 months postoperative

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  48. Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.

    Time frame: 6 months postoperative

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  49. Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.

    Time frame: 1 year postoperative

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  50. Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.

    Time frame: 1 year postoperative

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  51. Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety.

    Time frame: 2 years postoperative

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  52. Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety.

    Time frame: 2 years postoperative

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  53. Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.

    Time frame: Baseline

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  54. Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.

    Time frame: Postoperative day 1

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  55. Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.

    Time frame: Postoperative day 2

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  56. Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.

    Time frame: Postoperative day 5

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  57. Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.

    Time frame: 6 weeks postoperative

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  58. Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.

    Time frame: 6 months postoperative

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  59. Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.

    Time frame: 1 year postoperative

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  60. Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia.

    Time frame: 2 years postoperative

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  61. Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").

    Time frame: Baseline

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  62. Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").

    Time frame: Postoperative day 1

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  63. Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").

    Time frame: Postoperative day 2

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  64. Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").

    Time frame: Postoperative day 5

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  65. Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").

    Time frame: 6 weeks postoperative

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  66. Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").

    Time frame: 6 months postoperative

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  67. Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").

    Time frame: 1 year postoperative

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

  68. Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper").

    Time frame: 2 years postoperative

    Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm.

Sponsors and collaborators

Lead sponsor

Catherine Ferland

Other

Registry information

Official study title

Peri-operative Pain Assessment in Children Undergoing Orthopaedic Surgery

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2020
Registry last updated
May 4, 2022

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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