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

NCT07008924 | Active Not Recruiting

• 1 other identifier: STUDY00148602
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Low-back Pain; Insomnia; Sleep

Keywords

Partial sleep restriction; Chronic low back pain; Insomnia

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (13)

• Sleep Measures

  Through study completion, up to 5 weeks

• Pain Measures

  Through study completion, up to 5 weeks

• Pain Measures

  Through study completion, up to 5 weeks

• Pain Measures

  Through study completion, up to 5 weeks

• Pain Measures

  Through study completion, up to 5 weeks

Study Arms (2)

Healthy Control

Healthy control group will consist of those without any pain and sleep issues.

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

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.

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

Interventions

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

Return to normal sleep observation.

Chronic Low Back Pain (CLBP); Healthy Control

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 25-65 years old individuals
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Neena Sharma

  university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: June 6, 2025
• Study Start: July 14, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)