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

Chronic Low Back Pain Clinical Trial

Official title:

Sleep, Pain and Function in People With Chronic Spinal Pain and Comorbid Insomnia Compared to People With Chronic Spinal Pain Without Insomnia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03796481
• Other study ID #: EC/2018/0277/Amend
• Status: Completed
• Start date: January 8, 2019
• Est. completion date: July 28, 2022

Study information

• Verified date: November 2022
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: July 28, 2022
• Est. primary completion date: July 28, 2022
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Insomnia
• Chronic Low Back Pain
• Chronic Neck Pain
• Low Back Pain
• Neck Pain
• Sleep Initiation and Maintenance Disorders

Locations

Country	Name	City	State
Belgium	Vrije Universiteit Brussel	Brussel
Belgium	Ghent University	Ghent

Sponsors (5)

Lead Sponsor	Collaborator
University Ghent	Research Foundation Flanders, Universitair Ziekenhuis Brussel, University Hospital, Ghent, Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.