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| Name | Class |
|---|---|
| Vrije Universiteit Brussel | OTHER |
| University Hospital, Ghent | OTHER |
| Universitair Ziekenhuis Brussel | OTHER |
| Research Foundation Flanders |
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This study is focused on people with chronic spinal pain. To investigate the impact of sleep problems on pain and function, 45 people with chronic spinal pain and comorbid insomnia will be compared to 45 people with chronic spinal pain without insomnia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | People with chronic spinal pain (i.e. chronic low back pain or chronic neck pain) with comorbid insomnia | ||
| Controls | People with chronic spinal pain (i.e. chronic low back pain or chronic neck pain) without comorbid insomnia |
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| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory (Numeric Rating Scale): Pain intensity | Self-reported pain: The question "please rate your pain by circling the one number that best describes your pain on the AVERAGE" is used as the primary outcome measure to evaluate pain intensity. Scale ranges from 0 to 10, with higher scores indicating more self-reported pain. | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory: Pain Interference | Self-reported central sensitization symptoms. Score ranges from 0 to 100, with higher scores indicating more self-reported symptoms of central sensitization. | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. |
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Inclusion criteria cases:
Exclusion criteria cases:
Inclusion criteria controls:
Exclusion criteria controls:
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People with chronic spinal pain with and without comorbid insomnia (cases vs controls)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vrije Universiteit Brussel | Brussels | Belgium | ||||
| Ghent University |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| OTHER |
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| Central sensitization Inventory |
Self-reported central sensitization symptoms. Score ranges from 0 to 100, with higher scores indicating more self-reported symptoms of central sensitization. |
| Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. |
| Pressure Pain Thresholds | Pressure Pain Thresholds at measured bilaterally with a digital pressure algometer (Wagner Instruments), both at symptomatic levels (trapezius muscle and 5 centimetres lateral to the spinous process of L3) and at remote sites (i.e. secondary hyperalgesia). | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. |
| Sleep: Polysomnography (PSG) using the portable Alice PDX system, Philips Respironics Inc | Participants will be monitored in the comfort of their own home by ambulatory polysomnography. This will provide the following parameters: time in bed, total sleep time, sleep onset latency, wake duration after sleep onset, early morning awakening, sleep staging, sleep efficiency, sleep fragmentation, respiratory parameters, cardiac and myoclonic activity. | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. |
| Pittsburg Sleep Quality Index | Self-reported perceived sleep quality. Score ranges from 0 to 21, 0 indicating no difficulty and 21 indicating severe sleep difficulties. | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. |
| Insomnia Severity Index | Self-reported insomnia severity. Score ranges from 0 to 28, with 0 indicating no clinically significant insomnia and 28 indicating severe clinical insomnia. | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. |
| DBAS (i.e. Dysfunctional Beliefs and Attitudes about Sleep) | Change in self-reported dysfunctional beliefs and attitudes about sleep. Score ranges from 0 to 10. Scores above 4 indicate unrealistic expectations for sleep or unrealistic thoughts about sleep. | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. |
| Epworth Sleepiness Scale | Self-reported sleep propensity. Score ranges from 0 to 24, with 0 indicating normal daytime sleepiness and 24 indicating severe excessive daytime sleepiness. | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. |
| Brugmann Fatigue Scale | Self-reported fatigue severity. Score ranges from 0 to 24, with higher scores indicating higher subjective levels of fatigue. | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. |
| Hospital Anxiety and Depression rating scale | Self-reported affective symptoms. Score ranges from 0 to 21, with 0 indicating absence of depression or anxiety and 21 indicating the presence of depression or anxiety. | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. |
| Physical Activity using Actigraphy | Physical activity: Continuous assessment of physical activity and rest/activity cycles | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. |
| Short Form Health Survey - 36 items Mental Health | Self-reported functional status and well-being or quality of life. Score ranges from 0 to 400 with higher scores indicating better mental health. | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. |
| Short Form Health Survey - 36 items Physical Health | Self-reported functional status and well-being or quality of life. Score ranges from 0 to 400 with higher scores indicating better physical health. | Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021. |
| Ghent |
| Belgium |
| D001523 |
| Mental Disorders |