University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
NCT Number: NCT07008924
Our goal is to observational study is to determine feasibility of partial sleep restriction in individuals with CLBP+I and correlation findings with features of central sensitization.
* Identify feasibility of sleep restriction protocol * Identify correlation between less sleep and central sensitization Sleep will be monitored for 2 weeks (baseline sleep monitoring period). Then participants will be asked to restrict their sleep to 80% of their normal sleep duration for 5 nights (sleep restriction period). Then sleep will be monitored again for 2 weeks (sleep recovery period).
This study is active but is not currently recruiting participants.
25 year–65 year
All sexes
Observational
Kansas City, Kansas, 66160, United States
Actigraph and sleep diaries will be used to record sleep time and quality of sleep for 2 weeks baseline period. During this period several measures for pain, sleep, fatigue, cognition, and psychological status will be completed. Quantitative sensory testing will be used to establish pain threshold. Then, the participants will partial sleep restriction (20% sleep reduction/night for 5 nights). Following the completion of restricted sleep period, all outcome measures related to pain, sleep, fatigue, cognition, and psychological status will be assessed (post-sleep restriction assessment). Then participants' sleep will be monitored for 2-weeks (sleep recovery period). During the 5-night of sleep restriction, participants will be asked to complete electronic daily diary related to sleep, pain, fatigue, psychological distress and physical activity. Potential risk related to less sleep will be clearly explained to all potential individuals interested in participating.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Additional inclusion criteria for individuals with CLBP+I:
Exclusion criteria
Additional exclusion criteria for HC individuals:
Return to normal sleep observation.
Time frame: Through study completion, up to 5 weeks
Daily electronic sleep diaries
Time frame: Through study completion, up to 5 weeks
Insomnia Severity Index (ISI)
Time frame: Through study completion, up to 5 weeks
Pittsburgh Sleep Quality
Time frame: Through study completion, up to 5 weeks
Daily pain diaries
Time frame: Through study completion, up to 5 weeks
SF-McGill (MPQ),
Time frame: Through study completion, up to 5 weeks
Actigraphy- wearable sensor to record sleep quality and duration.
Time frame: Through study completion, up to 5 weeks
Numeric pain rating
Time frame: Through study completion, up to 5 weeks
2011 FM Survey
Time frame: Through study completion, up to 5 weeks
McGill pain questionnaire
Time frame: Through study completion, up to 5 weeks
Pressure pain threshold (PPT), lower back and dominant thumbnail
Time frame: Through study completion, up to 5 weeks
Conditioned Pain Modulation (CPM):lower back and dominant thumbnail
Time frame: Through study completion, up to 5 weeks
Pinprick assessment
Time frame: Through study completion, up to 5 weeks
Beck Anxiety Index (BAI)
Time frame: Through study completion, up to 5 weeks
Beck Depression Inventory (BDI-I)
Time frame: Through study completion, up to 5 weeks
Perceived Stress Scale (PSS)
Time frame: Through study completion, up to 5 weeks
Multidimensional Fatigue Inventory (MFI)- quantify different facets of fatigue.
Time frame: Through study completion, up to 5 weeks
Catastrophizing Scale (PCS)
Time frame: Through study completion, up to 5 weeks
For sleep restriction and recovery periods
University of Kansas Medical Center
Other
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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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