Cognitive Behavioural Therapy for Insomnia in Chronic Spinal Pain
NCT03482856
Chronic Low Back Pain, Chronic Neck Pain
Brussels, Brussels Capital, Belgium
View Trial DetailsNCT Number: NCT03796481
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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Notify Me18 year–65 year
All sexes
Observational
Vrije Universiteit Brussel, Brussels, Belgium
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
cases:
Exclusion criteria
cases:
Inclusion criteria
controls:
Exclusion criteria
controls:
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
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.
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Self-reported central sensitization symptoms. Score ranges from 0 to 100, with higher scores indicating more self-reported symptoms of central sensitization.
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Self-reported central sensitization symptoms. Score ranges from 0 to 100, with higher scores indicating more self-reported symptoms of central sensitization.
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
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).
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
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.
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Self-reported perceived sleep quality. Score ranges from 0 to 21, 0 indicating no difficulty and 21 indicating severe sleep difficulties.
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Self-reported insomnia severity. Score ranges from 0 to 28, with 0 indicating no clinically significant insomnia and 28 indicating severe clinical insomnia.
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
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.
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Self-reported sleep propensity. Score ranges from 0 to 24, with 0 indicating normal daytime sleepiness and 24 indicating severe excessive daytime sleepiness.
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Self-reported fatigue severity. Score ranges from 0 to 24, with higher scores indicating higher subjective levels of fatigue.
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
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.
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Physical activity: Continuous assessment of physical activity and rest/activity cycles
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Self-reported functional status and well-being or quality of life. Score ranges from 0 to 400 with higher scores indicating better mental health.
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Self-reported functional status and well-being or quality of life. Score ranges from 0 to 400 with higher scores indicating better physical health.
University Ghent
Other
Sleep, Pain and Function in People With Chronic Spinal Pain and Comorbid Insomnia Compared to People With Chronic Spinal Pain Without Insomnia.
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View the official ClinicalTrials.gov record (opens in a new tab)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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