Skip to content

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

Active, not recruitingNCT07008924
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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).

Study details

Official title
Partial Sleep Restriction in Chronic Low Back Pain: A Feasibility Study
Interventions
  • Other: No intervention is provided. We monitor natural recovery to full sleep.
Sponsor
University of Kansas Medical Center
Start date
2022-07-14
Primary completion
2025-12-31
Sex
All
Age range
from 25 Years to 65 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 exclusion criteria for HC individuals: • pain rating 0 out of 0 - 10 Numeric Rating Pain Scale in any parts of the body

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07008924