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Active, Not Recruiting

NCT Number: NCT07008924

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Return to normal sleep observation.

Primary outcomes

  1. Sleep Measures

    Time frame: Through study completion, up to 5 weeks

    Daily electronic sleep diaries

  2. Sleep Measures

    Time frame: Through study completion, up to 5 weeks

    Insomnia Severity Index (ISI)

  3. Sleep Measures

    Time frame: Through study completion, up to 5 weeks

    Pittsburgh Sleep Quality

  4. Pain Measures

    Time frame: Through study completion, up to 5 weeks

    Daily pain diaries

  5. Pain Measures

    Time frame: Through study completion, up to 5 weeks

    SF-McGill (MPQ),

Secondary outcomes

  1. Sleep Measures

    Time frame: Through study completion, up to 5 weeks

    Actigraphy- wearable sensor to record sleep quality and duration.

  2. Pain Measures

    Time frame: Through study completion, up to 5 weeks

    Numeric pain rating

  3. Pain Measures

    Time frame: Through study completion, up to 5 weeks

    2011 FM Survey

  4. Pain Measures

    Time frame: Through study completion, up to 5 weeks

    McGill pain questionnaire

  5. Pain Measures

    Time frame: Through study completion, up to 5 weeks

    Pressure pain threshold (PPT), lower back and dominant thumbnail

  6. Pain Measures

    Time frame: Through study completion, up to 5 weeks

    Conditioned Pain Modulation (CPM):lower back and dominant thumbnail

  7. Pain Measures

    Time frame: Through study completion, up to 5 weeks

    Pinprick assessment

  8. Psychological Measures

    Time frame: Through study completion, up to 5 weeks

    Beck Anxiety Index (BAI)

  9. Psychological Measures

    Time frame: Through study completion, up to 5 weeks

    Beck Depression Inventory (BDI-I)

  10. Psychological Measures

    Time frame: Through study completion, up to 5 weeks

    Perceived Stress Scale (PSS)

  11. Psychological Measures

    Time frame: Through study completion, up to 5 weeks

    Multidimensional Fatigue Inventory (MFI)- quantify different facets of fatigue.

  12. Psychological Measures

    Time frame: Through study completion, up to 5 weeks

    Catastrophizing Scale (PCS)

  13. Daily questionnaire

    Time frame: Through study completion, up to 5 weeks

    For sleep restriction and recovery periods

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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