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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Control | Healthy control group will consist of those without any pain and sleep issues. |
| |
| Chronic Low Back Pain (CLBP) | CLBP group will consist of those with LBP. Individuals with CLBP who also experience minor sleep issues are also eligible. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention is provided. We monitor natural recovery to full sleep. | Other | Return to normal sleep observation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Measures | Daily electronic sleep diaries | Through study completion, up to 5 weeks |
| Sleep Measures | Insomnia Severity Index (ISI) | Through study completion, up to 5 weeks |
| Sleep Measures | Pittsburgh Sleep Quality | Through study completion, up to 5 weeks |
| Pain Measures | Daily pain diaries | Through study completion, up to 5 weeks |
| Pain Measures | SF-McGill (MPQ), | Through study completion, up to 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Measures | Actigraphy- wearable sensor to record sleep quality and duration. | Through study completion, up to 5 weeks |
| Pain Measures | Numeric pain rating |
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Inclusion Criteria:
• 25-65 years old individuals
Additional inclusion criteria for individuals with CLBP+I:
Exclusion Criteria:
Additional exclusion criteria for HC individuals:
• pain rating 0 out of 0 - 10 Numeric Rating Pain Scale in any parts of the body
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We will primarily recruit patients via word of mouth, by placing study flyers throughout KU hospital and KUMC and social media e.g. broadcast, facebook, etc. We may also use KUMC's CTSA Frontiers patient registry to recruit participants with LBP. Attach is a copy of study flyer.
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| Name | Affiliation | Role |
|---|---|---|
| Neena Sharma | university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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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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| Through study completion, up to 5 weeks |
| Pain Measures | 2011 FM Survey | Through study completion, up to 5 weeks |
| Pain Measures | McGill pain questionnaire | Through study completion, up to 5 weeks |
| Pain Measures | Pressure pain threshold (PPT), lower back and dominant thumbnail | Through study completion, up to 5 weeks |
| Pain Measures | Conditioned Pain Modulation (CPM):lower back and dominant thumbnail | Through study completion, up to 5 weeks |
| Pain Measures | Pinprick assessment | Through study completion, up to 5 weeks |
| Psychological Measures | Beck Anxiety Index (BAI) | Through study completion, up to 5 weeks |
| Psychological Measures | Beck Depression Inventory (BDI-I) | Through study completion, up to 5 weeks |
| Psychological Measures | Perceived Stress Scale (PSS) | Through study completion, up to 5 weeks |
| Psychological Measures | Multidimensional Fatigue Inventory (MFI)- quantify different facets of fatigue. | Through study completion, up to 5 weeks |
| Psychological Measures | Catastrophizing Scale (PCS) | Through study completion, up to 5 weeks |
| Daily questionnaire | For sleep restriction and recovery periods | Through study completion, up to 5 weeks |
| D001523 |
| Mental Disorders |