Chronic Low-back PainNCT07008924
Partial Sleep Restriction in Chronic Low Back Pain: A Feasibility Study
An observational study of Chronic Low-back Pain and Insomnia, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain, Insomnia, Sleep
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2022to 31 Dec 2025
- How long will I take part?
- 5 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this 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).
Read the 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.
- Conditions
- Chronic Low-back Pain, Insomnia, Sleep
- Being tested
- No intervention is provided. We monitor natural recovery to full sleep.
- Keywords
- Partial sleep restriction, Chronic low back pain, Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is provided. We monitor natural recovery to full sleep.Other
Return to normal sleep observation.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Healthy control group will consist of those without any pain and sleep issues. Receives: 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. Receives: Other: No intervention is provided. We monitor natural recovery to full sleep. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Measures
Daily electronic sleep diaries
Measured: Through study completion, up to 5 weeks
Sleep Measures
Insomnia Severity Index (ISI)
Measured: Through study completion, up to 5 weeks
Sleep Measures
Pittsburgh Sleep Quality
Measured: Through study completion, up to 5 weeks
Pain Measures
Daily pain diaries
Measured: Through study completion, up to 5 weeks
Pain Measures
SF-McGill (MPQ),
Measured: Through study completion, up to 5 weeks
Secondary outcomes (13)
Sleep Measures
Actigraphy- wearable sensor to record sleep quality and duration.
Measured: Through study completion, up to 5 weeks
Pain Measures
Numeric pain rating
Measured: Through study completion, up to 5 weeks
Pain Measures
2011 FM Survey
Measured: Through study completion, up to 5 weeks
Pain Measures
McGill pain questionnaire
Measured: Through study completion, up to 5 weeks
Pain Measures
Pressure pain threshold (PPT), lower back and dominant thumbnail
Measured: Through study completion, up to 5 weeks
Pain Measures
Conditioned Pain Modulation (CPM):lower back and dominant thumbnail
Measured: Through study completion, up to 5 weeks
Pain Measures
Pinprick assessment
Measured: Through study completion, up to 5 weeks
Psychological Measures
Beck Anxiety Index (BAI)
Measured: Through study completion, up to 5 weeks
Psychological Measures
Beck Depression Inventory (BDI-I)
Measured: Through study completion, up to 5 weeks
Psychological Measures
Perceived Stress Scale (PSS)
Measured: Through study completion, up to 5 weeks
Psychological Measures
Multidimensional Fatigue Inventory (MFI)- quantify different facets of fatigue.
Measured: Through study completion, up to 5 weeks
Psychological Measures
Catastrophizing Scale (PCS)
Measured: Through study completion, up to 5 weeks
Daily questionnaire
For sleep restriction and recovery periods
Measured: Through study completion, up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start14 Jul 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 5 Weeks
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neena Sharma, PT, PhD, CMPT, University of Kansas Medical Center
- Investigators
- Neena Sharma, Principal investigator, university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008924
- Sponsor's protocol ID
- STUDY00148602
- Status last verified
- Jun 2025
- First submitted
- 20 Jul 2022
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Sleep Restriction in Chronic Low Back Pain: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07008924
- Acronym / sponsor ID
- STUDY00148602
- Conditions
- Chronic Low-back Pain, Insomnia, Sleep
- Keywords
- Partial sleep restriction, Chronic low back pain, Insomnia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | Other: No intervention is provided. We monitor natural recovery to full sleep.Healthy control group will consist of those without any pain and sleep issues. |
| Chronic Low Back Pain (CLBP) | – | Other: No intervention is provided. We monitor natural recovery to full sleep.CLBP group will consist of those with LBP. Individuals with CLBP who also experience minor sleep issues are also eligible. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention is provided. We monitor natural recovery to full sleep.Return to normal sleep observation. | Other | Chronic Low Back Pain (CLBP), Healthy Control |
Primary outcome
Sleep Measures
Time frame: Through study completion, up to 5 weeks
Daily electronic sleep diaries
Sleep Measures
Time frame: Through study completion, up to 5 weeks
Insomnia Severity Index (ISI)
Sleep Measures
Time frame: Through study completion, up to 5 weeks
Pittsburgh Sleep Quality
Pain Measures
Time frame: Through study completion, up to 5 weeks
Daily pain diaries
Pain Measures
Time frame: Through study completion, up to 5 weeks
SF-McGill (MPQ),
13 secondary outcomes
Sleep Measures
Time frame: Through study completion, up to 5 weeks
Pain Measures
Time frame: Through study completion, up to 5 weeks
Pain Measures
Time frame: Through study completion, up to 5 weeks
Pain Measures
Time frame: Through study completion, up to 5 weeks
Pain Measures
Time frame: Through study completion, up to 5 weeks
Pain Measures
Time frame: Through study completion, up to 5 weeks
Pain Measures
Time frame: Through study completion, up to 5 weeks
Psychological Measures
Time frame: Through study completion, up to 5 weeks
Psychological Measures
Time frame: Through study completion, up to 5 weeks
Psychological Measures
Time frame: Through study completion, up to 5 weeks
Psychological Measures
Time frame: Through study completion, up to 5 weeks
Psychological Measures
Time frame: Through study completion, up to 5 weeks
Daily questionnaire
Time frame: Through study completion, up to 5 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neena Sharma principal investigator
university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low-back Pain and Insomnia, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Measures (time frame: Through study completion, up to 5 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.