Partial Sleep Restriction in Chronic Low Back Pain: A Feasibility Study
NCT ID: NCT07008924
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
50 participants
OBSERVATIONAL
2022-07-14
2025-12-31
Brief Summary
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* 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).
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Healthy Control
Healthy control group will consist of those without any pain and sleep issues.
No intervention is provided. We monitor natural recovery to full sleep.
Return to normal sleep observation.
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.
No intervention is provided. We monitor natural recovery to full sleep.
Return to normal sleep observation.
Interventions
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No intervention is provided. We monitor natural recovery to full sleep.
Return to normal sleep observation.
Eligibility Criteria
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Inclusion Criteria
* With or without insomnia
* CLBP (LBP for at least 3 months with or without referred or radiating leg pain; pain intensity 1 or greater on 0 - 10 VAS scale
* likely to participate in all scheduled evaluations and study procedures by self-report
* agrees to abide by safely protocol e.g. not to drive or operate heavy machinery and perform heavy labor work, during the sleep-restriction period
Exclusion Criteria
* neurological conditions such as stroke, Parkinson's disease, Alzheimer's disease or other cognitive impairments.
* pregnancy
* known untreated sleep disorder (such as current sleep apnea or current restless leg syndrome) screened by the following scales to ensure insomnia symptoms are due to insomnia and not another common sleep disorders:
* Those with increased risk of sleep apnea
* Increased risk of restless leg syndrome on RLS-Diagnosis Index
* Increased risk of circadian rhythm sleep-wake disorder
* Increased risk of parasomnia
* Moderate level of depression identified by Patient Health Questionnaire (PHQ-9)
* Moderate level of anxiety identify by Generalized Anxiety Disorder (GAD-7)
* history of drug or alcohol abuse as defined by DSM-IV criteria within the last 2 years
* severe mental illness such as schizophrenia or bipolar disorder
* developmental history of learning disability or attention-deficit/hyperactivity disorder
* is currently receiving CBT-I, physical therapy or chiropractic treatment
* history of spinal surgery
* current use of blood thinning medications
* resting blood pressure greater than 160/90 mmHg40,49,50
* performs overnight shift work
• pain rating 0 out of 0 - 10 Numeric Rating Pain Scale in any parts of the body
25 Years
65 Years
ALL
Yes
Sponsors
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University of Kansas Medical Center
OTHER
Responsible Party
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Neena Sharma, PT, PhD, CMPT
Associate Professor
Principal Investigators
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Neena Sharma
Role: PRINCIPAL_INVESTIGATOR
university
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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Other Identifiers
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STUDY00148602
Identifier Type: -
Identifier Source: org_study_id
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