Chronic Low Back PainNCT03796481
Sleep, Pain and Function in People With Chronic Spinal Pain and Comorbid Insomnia
An observational study of Chronic Low Back Pain and Chronic Neck Pain, run by University Ghent at 2 sites in Belgium.
Trial summary
This study is focused on people with chronic spinal pain. To investigate the impact of sleep problems on pain and function, 45 people with chronic spinal pain and comorbid insomnia will be compared to 45 people with chronic spinal pain without insomnia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain, Chronic Neck Pain, Chronic Insomnia
- How many people
- 123 participants
- Where
- 2 sitesBelgium
- Study dates
- 8 Jan 2019to 28 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: People with chronic spinal pain with and without comorbid insomnia (cases vs controls)
Who may be able to join
- nonspecific spinal pain (≥3 days per week and ≥3 months of chronic low back pain, failed back surgery syndrome > 3 years prior, chronic whiplash, or chronic non traumatic neck pain)
- aged between 18 and 65 years
- seeking care because of neck pain or low back pain
- native dutch speaker
- having insomnia: in the absence of other intrinsic sleep disorders and shift work, insomnia is defined as > 30 minutes of sleep latency and/or minutes awake after sleep onset for > 3 days / week for > 6 months
- living or working within a radius of 50 km around the test location
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- not starting new treatments or medication and continuing their usual care 6 weeks prior to and during study participation (to obtain steady state)
- referring from analgesics, caffeine, alcohol or nicotine in the previous 48 h of the assessments
- nonspecific failed back surgery > 3 years are permitted
- not undertaking exercise (>3 metabolic equivalents) 3 days before the experiment
- native dutch speaking
- 18 to 65 years of age
- having chronic nonspecific chronic spinal pain (≥3 days per week and ≥3 months of chronic low back pain, failed back surgery syndrome > 3 years prior, chronic whiplash, or chronic non traumatic neck pain)
- referring from analgesics, caffeine, alcohol or nicotine in the previous 48 h of the assessments
- not undertaking exercise (>3 metabolic equivalents) 3 days before the experiment
- No new medication 6 weeks prior to the assessment
- currently not undergoing any treatment (excl. medication) for chronic spinal pain
Who cannot join
- severe underlying sleep pathology (identified through baseline data of polysomnography)
- neuropathic pain
- chronic widespread pain
- being pregnant or pregnancy (including giving birth) in the preceding year
- history of specific spinal surgery
- thoracic pain in absence of neck or low back pain
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- shift workers
- present clinical depression
- BMI ≥ 30
- specific medical conditions (neuropathic pain, specific neck of back surgery, osteoporotic vertebral fractures, or rheumatologic diseases)
- chronic widespread pain syndromes (fibromyalgia or chronic fatigue syndrome)
- having insomnia (in the absence of other intrinsic sleep disorders and shift work, insomnia is defined as > 30 minutes of sleep latency and/or minutes awake after sleep onset for > 3 days / week for > 6 months)
- severe underlying sleep pathology
- being pregnant or pregnancy in the preceding year
- thoracic pain in the absence of neck or low back pain
- diagnosed depression
- BMI over 30
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Sleep, Pain and Function in People With Chronic Spinal Pain and Comorbid Insomnia Compared to People With Chronic Spinal Pain Without Insomnia.
This study is focused on people with chronic spinal pain. To investigate the impact of sleep problems on pain and function, 45 people with chronic spinal pain and comorbid insomnia will be compared to 45 people with chronic spinal pain without insomnia.
- Conditions
- Chronic Low Back Pain, Chronic Neck Pain, Chronic 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.
| Study group | Role | What they receive |
|---|---|---|
| Cases | People with chronic spinal pain (i.e. chronic low back pain or chronic neck pain) with comorbid insomnia | |
| Controls | People with chronic spinal pain (i.e. chronic low back pain or chronic neck pain) without comorbid insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory (Numeric Rating Scale): Pain intensity
Self-reported pain: The question "please rate your pain by circling the one number that best describes your pain on the AVERAGE" is used as the primary outcome measure to evaluate pain intensity. Scale ranges from 0 to 10, with higher scores indicating more self-reported pain.
Measured: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Secondary outcomes (13)
Brief Pain Inventory: Pain Interference
Self-reported central sensitization symptoms. Score ranges from 0 to 100, with higher scores indicating more self-reported symptoms of central sensitization.
Measured: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Central sensitization Inventory
Self-reported central sensitization symptoms. Score ranges from 0 to 100, with higher scores indicating more self-reported symptoms of central sensitization.
Measured: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Pressure Pain Thresholds
Pressure Pain Thresholds at measured bilaterally with a digital pressure algometer (Wagner Instruments), both at symptomatic levels (trapezius muscle and 5 centimetres lateral to the spinous process of L3) and at remote sites (i.e. secondary hyperalgesia).
Measured: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Sleep: Polysomnography (PSG) using the portable Alice PDX system, Philips Respironics Inc
Participants will be monitored in the comfort of their own home by ambulatory polysomnography. This will provide the following parameters: time in bed, total sleep time, sleep onset latency, wake duration after sleep onset, early morning awakening, sleep staging, sleep efficiency, sleep fragmentation, respiratory parameters, cardiac and myoclonic activity.
Measured: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Pittsburg Sleep Quality Index
Self-reported perceived sleep quality. Score ranges from 0 to 21, 0 indicating no difficulty and 21 indicating severe sleep difficulties.
Measured: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Insomnia Severity Index
Self-reported insomnia severity. Score ranges from 0 to 28, with 0 indicating no clinically significant insomnia and 28 indicating severe clinical insomnia.
Measured: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
DBAS (i.e. Dysfunctional Beliefs and Attitudes about Sleep)
Change in self-reported dysfunctional beliefs and attitudes about sleep. Score ranges from 0 to 10. Scores above 4 indicate unrealistic expectations for sleep or unrealistic thoughts about sleep.
Measured: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Epworth Sleepiness Scale
Self-reported sleep propensity. Score ranges from 0 to 24, with 0 indicating normal daytime sleepiness and 24 indicating severe excessive daytime sleepiness.
Measured: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Brugmann Fatigue Scale
Self-reported fatigue severity. Score ranges from 0 to 24, with higher scores indicating higher subjective levels of fatigue.
Measured: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Hospital Anxiety and Depression rating scale
Self-reported affective symptoms. Score ranges from 0 to 21, with 0 indicating absence of depression or anxiety and 21 indicating the presence of depression or anxiety.
Measured: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Physical Activity using Actigraphy
Physical activity: Continuous assessment of physical activity and rest/activity cycles
Measured: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Short Form Health Survey - 36 items Mental Health
Self-reported functional status and well-being or quality of life. Score ranges from 0 to 400 with higher scores indicating better mental health.
Measured: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Short Form Health Survey - 36 items Physical Health
Self-reported functional status and well-being or quality of life. Score ranges from 0 to 400 with higher scores indicating better physical health.
Measured: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start8 Jan 2019
- Primary completion28 Jul 2022
- Study completion28 Jul 2022
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.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel, University Hospital, Ghent, Universitair Ziekenhuis Brussel, Research Foundation Flanders
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796481
- Sponsor's protocol ID
- EC/2018/0277/Amend
- Status last verified
- Nov 2022
- First submitted
- 19 Dec 2018
- Last updated
- 1 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, Pain and Function in People With Chronic Spinal Pain and Comorbid Insomnia Compared to People With Chronic Spinal Pain Without Insomnia.
- ClinicalTrials.gov ID
- NCT03796481
- Acronym / sponsor ID
- EC/2018/0277/Amend
- Conditions
- Chronic Low Back Pain, Chronic Neck Pain, Chronic Insomnia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel, University Hospital, Ghent, Universitair Ziekenhuis Brussel, Research Foundation Flanders
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 8 Jan 2019 (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.
This study is focused on people with chronic spinal pain. To investigate the impact of sleep problems on pain and function, 45 people with chronic spinal pain and comorbid insomnia will be compared to 45 people with chronic spinal pain without insomnia.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –People with chronic spinal pain (i.e. chronic low back pain or chronic neck pain) with comorbid insomnia |
| Controls | – | –People with chronic spinal pain (i.e. chronic low back pain or chronic neck pain) without comorbid insomnia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People with chronic spinal pain with and without comorbid insomnia (cases vs controls)
Key inclusion criteria (17 listed)
- nonspecific spinal pain (≥3 days per week and ≥3 months of chronic low back pain, failed back surgery syndrome > 3 years prior, chronic whiplash, or chronic non traumatic neck pain)
- aged between 18 and 65 years
- seeking care because of neck pain or low back pain
- native dutch speaker
- having insomnia: in the absence of other intrinsic sleep disorders and shift work, insomnia is defined as > 30 minutes of sleep latency and/or minutes awake after sleep onset for > 3 days / week for > 6 months
Key exclusion criteria (17 listed)
- severe underlying sleep pathology (identified through baseline data of polysomnography)
- neuropathic pain
- chronic widespread pain
- being pregnant or pregnancy (including giving birth) in the preceding year
- history of specific spinal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brief Pain Inventory (Numeric Rating Scale): Pain intensity
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Self-reported pain: The question "please rate your pain by circling the one number that best describes your pain on the AVERAGE" is used as the primary outcome measure to evaluate pain intensity. Scale ranges from 0 to 10, with higher scores indicating more self-reported pain.
13 secondary outcomes
Brief Pain Inventory: Pain Interference
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Central sensitization Inventory
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Pressure Pain Thresholds
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Sleep: Polysomnography (PSG) using the portable Alice PDX system, Philips Respironics Inc
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Pittsburg Sleep Quality Index
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Insomnia Severity Index
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
DBAS (i.e. Dysfunctional Beliefs and Attitudes about Sleep)
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Epworth Sleepiness Scale
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Brugmann Fatigue Scale
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Hospital Anxiety and Depression rating scale
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Physical Activity using Actigraphy
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Short Form Health Survey - 36 items Mental Health
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Short Form Health Survey - 36 items Physical Health
Time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Chronic Neck Pain, run by University Ghent at 2 sites in Belgium.
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 17 inclusion and 17 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: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Brief Pain Inventory (Numeric Rating Scale): Pain intensity (time frame: Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.). 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 1 Dec 2022.