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

Completed

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

• Registration Number: NCT03796481
• Lead Sponsor: University Ghent

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 available

Study Timeline

• Study First Submitted: 2018-12-19
• Study First Submitted QC: 2019-01-07
• Study Start: 2019-01-08
• Study First Posted: 2019-01-08
• Primary Completion: 2022-07-28
• Study Completion: 2022-07-28
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory (Numeric Rating Scale): Pain intensity	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.

Secondary Outcome Measures

Name	Time	Method
Sleep: Polysomnography (PSG) using the portable Alice PDX system, Philips Respironics Inc	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.
Brief Pain Inventory: Pain Interference	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	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.
Insomnia Severity Index	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.
Epworth Sleepiness Scale	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.
Physical Activity using Actigraphy	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
Pressure Pain Thresholds	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).
Hospital Anxiety and Depression rating scale	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.
Pittsburg Sleep Quality Index	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.
DBAS (i.e. Dysfunctional Beliefs and Attitudes about Sleep)	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.
Brugmann Fatigue Scale	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.
Short Form Health Survey - 36 items Mental Health	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	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.

Trial Locations

Locations (2)

Vrije Universiteit Brussel; 🇧🇪 Brussel, Belgium

Ghent University; 🇧🇪 Ghent, Belgium