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

University of Kansas

Status

Active, not recruiting

Conditions

Chronic Low-back Pain

Insomnia

Sleep

Treatments

Other: No intervention is provided. We monitor natural recovery to full sleep.

Study type

Observational

Funder types

Other

Identifiers

NCT07008924

STUDY00148602

Details and patient eligibility

About

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).

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

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