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Sleep, Pain and Function in People With Chronic Spinal Pain and Comorbid Insomnia

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ClinicalTrials.gov Identifier: NCT03796481
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : January 10, 2019
Sponsor:
Collaborators:
Vrije Universiteit Brussel
University Hospital, Ghent
Universitair Ziekenhuis Brussel
Research Foundation Flanders
Information provided by (Responsible Party):
University Ghent

Tracking Information
First Submitted Date December 19, 2018
First Posted Date January 8, 2019
Last Update Posted Date January 10, 2019
Actual Study Start Date January 8, 2019
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 7, 2019)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03796481 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 7, 2019)
  • 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. ]
    Self-reported central sensitization symptoms. Score ranges from 0 to 100, with higher scores indicating more self-reported symptoms of central sensitization.
  • 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. ]
    Self-reported central sensitization symptoms. Score ranges from 0 to 100, with higher scores indicating more self-reported symptoms of central sensitization.
  • 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. ]
    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).
  • 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. ]
    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.
  • 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. ]
    Self-reported perceived sleep quality. Score ranges from 0 to 21, 0 indicating no difficulty and 21 indicating severe sleep difficulties.
  • 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. ]
    Self-reported insomnia severity. Score ranges from 0 to 28, with 0 indicating no clinically significant insomnia and 28 indicating severe clinical insomnia.
  • 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. ]
    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.
  • 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. ]
    Self-reported sleep propensity. Score ranges from 0 to 24, with 0 indicating normal daytime sleepiness and 24 indicating severe excessive daytime sleepiness.
  • 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. ]
    Self-reported fatigue severity. Score ranges from 0 to 24, with higher scores indicating higher subjective levels of fatigue.
  • 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. ]
    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.
  • 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. ]
    Physical activity: Continuous assessment of physical activity and rest/activity cycles
  • 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. ]
    Self-reported functional status and well-being or quality of life. Score ranges from 0 to 400 with higher scores indicating better mental health.
  • 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. ]
    Self-reported functional status and well-being or quality of life. Score ranges from 0 to 400 with higher scores indicating better physical health.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sleep, Pain and Function in People With Chronic Spinal Pain and Comorbid Insomnia
Official Title Sleep, Pain and Function in People With Chronic Spinal Pain and Comorbid Insomnia Compared to People With Chronic Spinal Pain Without Insomnia.
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population People with chronic spinal pain with and without comorbid insomnia (cases vs controls)
Condition
  • Chronic Low Back Pain
  • Chronic Neck Pain
  • Chronic Insomnia
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 7, 2019)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria cases:

  • 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
  • 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

Exclusion criteria cases:

  • 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
  • shift workers
  • present clinical depression
  • BMI ≥ 30

Inclusion criteria controls:

  • 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

Exclusion criteria controls:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Anneleen Malfliet, PhD 003224774562 anneleen.malfliet@vub.be
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT03796481
Other Study ID Numbers EC/2018/0277/Amend
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Ghent
Study Sponsor University Ghent
Collaborators
  • Vrije Universiteit Brussel
  • University Hospital, Ghent
  • Universitair Ziekenhuis Brussel
  • Research Foundation Flanders
Investigators Not Provided
PRS Account University Ghent
Verification Date January 2019