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Partial Sleep Restriction in Chronic Low Back Pain: A Feasibility Study

Partial Sleep Restriction in Chronic Low Back Pain: A Feasibility Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07008924
Enrollment
50
Registered
2025-06-06
Start date
2022-07-14
Completion date
2025-12-31
Last updated
2025-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low-back Pain, Insomnia, Sleep

Keywords

Partial sleep restriction, Chronic low back pain, Insomnia

Brief summary

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).

Detailed description

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.

Interventions

OTHERNo intervention is provided. We monitor natural recovery to full sleep.

Return to normal sleep observation.

Sponsors

University of Kansas Medical Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

• 25-65 years old individuals Additional inclusion criteria for individuals with CLBP+I: * 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

* spine compression, tumor, infection, history of spine surgery * 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 Additional

Design outcomes

Primary

MeasureTime frameDescription
Sleep MeasuresThrough study completion, up to 5 weeksDaily electronic sleep diaries
Pain MeasuresThrough study completion, up to 5 weeksDaily pain diaries

Secondary

MeasureTime frameDescription
Sleep MeasuresThrough study completion, up to 5 weeksActigraphy- wearable sensor to record sleep quality and duration.
Pain MeasuresThrough study completion, up to 5 weeksNumeric pain rating
Psychological MeasuresThrough study completion, up to 5 weeksBeck Anxiety Index (BAI)
Daily questionnaireThrough study completion, up to 5 weeksFor sleep restriction and recovery periods

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026