Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients |
|
Baseline |
|
| Primary |
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients |
|
Postoperative day 1 |
|
| Primary |
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients |
|
Postoperative day 2 |
|
| Primary |
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients |
|
Postoperative day 5 |
|
| Primary |
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients |
|
6 weeks postoperative |
|
| Primary |
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients |
|
6 months postoperative |
|
| Primary |
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients |
|
1 year postoperative |
|
| Primary |
Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients |
|
2 years postoperative |
|
| Primary |
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain |
|
Baseline |
|
| Primary |
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain |
|
Postoperative day 1 |
|
| Primary |
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain |
|
Postoperative day 2 |
|
| Primary |
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain |
|
Postoperative day 5 |
|
| Primary |
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain |
|
6 weeks postoperative |
|
| Primary |
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain |
|
6 months postoperative |
|
| Primary |
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain |
|
1 year postoperative |
|
| Primary |
Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain |
|
2 years postoperative |
|
| Secondary |
Mechanical detection threshold (grams) as measured with von Frey filaments |
|
Baseline |
|
| Secondary |
Pain pressure threshold (Newtons) as measured with an algometer. |
|
Baseline |
|
| Secondary |
Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test. |
Conditioned pain modulation measurement is omitted in the non-verbal patient arm. |
Baseline |
|
| Secondary |
Mechanical detection threshold (grams) as measured with von Frey filaments |
|
Postoperative day 1 |
|
| Secondary |
Pain pressure threshold (Newtons) as measured with an algometer. |
|
Postoperative day 1 |
|
| Secondary |
Mechanical detection threshold (grams) as measured with von Frey filaments |
|
Postoperative day 2 |
|
| Secondary |
Pain pressure threshold (Newtons) as measured with an algometer. |
|
Postoperative day 2 |
|
| Secondary |
Mechanical detection threshold (grams) as measured with von Frey filaments |
|
Postoperative day 5 |
|
| Secondary |
Pain pressure threshold (Newtons) as measured with an algometer. |
|
Postoperative day 5 |
|
| Secondary |
Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test. |
Conditioned pain modulation measurement is omitted in the non-verbal patient arm. |
Postoperative day 5 |
|
| Secondary |
Mechanical detection threshold (grams) as measured with von Frey filaments |
|
6 weeks postoperative |
|
| Secondary |
Pain pressure threshold (Newtons) as measured with an algometer. |
|
6 weeks postoperative |
|
| Secondary |
Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test. |
Conditioned pain modulation measurement is omitted in the non-verbal patient arm. |
6 weeks postoperative |
|
| Secondary |
Mechanical detection threshold (grams) as measured with von Frey filaments |
|
6 months postoperative |
|
| Secondary |
Pain pressure threshold (Newtons) as measured with an algometer. |
|
6 months postoperative |
|
| Secondary |
Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test. |
Conditioned pain modulation measurement is omitted in the non-verbal patient arm. |
6 months postoperative |
|
| Secondary |
Mechanical detection threshold (grams) as measured with von Frey filaments |
|
1 year postoperative |
|
| Secondary |
Pain pressure threshold (Newtons) as measured with an algometer. |
|
1 year postoperative |
|
| Secondary |
Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test. |
Conditioned pain modulation measurement is omitted in the non-verbal patient arm. |
1 year postoperative |
|
| Secondary |
Mechanical detection threshold (grams) as measured with von Frey filaments |
|
2 years postoperative |
|
| Secondary |
Pain pressure threshold (Newtons) as measured with an algometer. |
|
2 years postoperative |
|
| Secondary |
Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test. |
Conditioned pain modulation measurement is omitted in the non-verbal patient arm. |
2 years postoperative |
|
| Secondary |
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
Baseline |
|
| Secondary |
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
Postoperative day 1 |
|
| Secondary |
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
Postoperative day 2 |
|
| Secondary |
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
Postoperative day 5 |
|
| Secondary |
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
6 weeks postoperative |
|
| Secondary |
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
6 months postoperative |
|
| Secondary |
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
1 year postoperative |
|
| Secondary |
Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
2 years postoperative |
|
| Secondary |
Total score (30-150) across to 4 domains of the Scoliosis Research Society Questionnaire-30 (SRS-30) regarding the outcome of the patient's spine surgery (items scored from 1=worst, to 5=best, thus lower scores mean worse outcomes). |
4 domains: 1) pain (max. score 30) 2) mental health (max. score 25) 3) function/activity (max. score 35) 4) Self Image/appearance (max. score 45) |
Baseline |
|
| Secondary |
Total score (30-150) across to 4 domains of the Scoliosis Research Society Questionnaire-30 (SRS-30) regarding the outcome of the patient's spine surgery (items scored from 1=worst, to 5=best, thus lower scores mean worse outcomes). |
4 domains: 1) pain (max. score 30) 2) mental health (max. score 25) 3) function/activity (max. score 35) 4) Self Image/appearance (max. score 45) |
6 weeks postoperative |
|
| Secondary |
Total score (30-150) across to 4 domains of the Scoliosis Research Society Questionnaire-30 (SRS-30) regarding the outcome of the patient's spine surgery (items scored from 1=worst, to 5=best, thus lower scores mean worse outcomes). |
4 domains: 1) pain (max. score 30) 2) mental health (max. score 25) 3) function/activity (max. score 35) 4) Self Image/appearance (max. score 45) |
6 months postoperative |
|
| Secondary |
Total score (30-150) across to 4 domains of the Scoliosis Research Society Questionnaire-30 (SRS-30) regarding the outcome of the patient's spine surgery (items scored from 1=worst, to 5=best, thus lower scores mean worse outcomes). |
4 domains: 1) pain (max. score 30) 2) mental health (max. score 25) 3) function/activity (max. score 35) 4) Self Image/appearance (max. score 45) |
1 year postoperative |
|
| Secondary |
Total score (30-150) across to 4 domains of the Scoliosis Research Society Questionnaire-30 (SRS-30) regarding the outcome of the patient's spine surgery (items scored from 1=worst, to 5=best, thus lower scores mean worse outcomes). |
4 domains: 1) pain (max. score 30) 2) mental health (max. score 25) 3) function/activity (max. score 35) 4) Self Image/appearance (max. score 45) |
2 years postoperative |
|
| Secondary |
Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
Baseline |
|
| Secondary |
Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
6 weeks postoperative |
|
| Secondary |
Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
6 months postoperative |
|
| Secondary |
Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
1 year postoperative |
|
| Secondary |
Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
2 years postoperative |
|
| Secondary |
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
Baseline |
|
| Secondary |
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
Baseline |
|
| Secondary |
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
Day of surgery |
|
| Secondary |
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
Day of surgery |
|
| Secondary |
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
6 weeks postoperative |
|
| Secondary |
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
6 weeks postoperative |
|
| Secondary |
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
6 months postoperative |
|
| Secondary |
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
6 months postoperative |
|
| Secondary |
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
1 year postoperative |
|
| Secondary |
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
1 year postoperative |
|
| Secondary |
Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
2 years postoperative |
|
| Secondary |
Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
2 years postoperative |
|
| Secondary |
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
Baseline |
|
| Secondary |
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
Postoperative day 1 |
|
| Secondary |
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
Postoperative day 2 |
|
| Secondary |
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
Postoperative day 5 |
|
| Secondary |
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
6 weeks postoperative |
|
| Secondary |
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
6 months postoperative |
|
| Secondary |
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
1 year postoperative |
|
| Secondary |
Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia. |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
2 years postoperative |
|
| Secondary |
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper"). |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
Baseline |
|
| Secondary |
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper"). |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
Postoperative day 1 |
|
| Secondary |
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper"). |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
Postoperative day 2 |
|
| Secondary |
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper"). |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
Postoperative day 5 |
|
| Secondary |
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper"). |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
6 weeks postoperative |
|
| Secondary |
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper"). |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
6 months postoperative |
|
| Secondary |
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper"). |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
1 year postoperative |
|
| Secondary |
Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper"). |
Completed by patient in verbal patient arm and by parent of the patient in non-verbal patient arm. |
2 years postoperative |
|
