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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain; Chronic Neck Pain; Chronic Insomnia

• Study Type: Observational
• Enrollment (Actual): 123

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium
    • Vrije Universiteit Brussel
  • Ghent, Belgium
    • Ghent University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People with chronic spinal pain with and without comorbid insomnia (cases vs controls)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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.	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.	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.	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.	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.	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.	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.	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	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.	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.	Participants will be tested one time only (one assessment) at one day, in between January 20, 2019 and April 30, 2021.

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: University Hospital, Ghent; Universitair Ziekenhuis Brussel; Vrije Universiteit Brussel; Research Foundation Flanders

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2019
• Primary Completion (Actual): July 28, 2022
• Study Completion (Actual): July 28, 2022

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (Actual): January 8, 2019

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Sleep Initiation and Maintenance Disorders; Neck Pain
• Other Study ID Numbers: EC/2018/0277/Amend

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No