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

University Ghent123 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

123

Conditions

Chronic Low Back Pain Chronic Neck Pain Chronic Insomnia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Vrije Universiteit Brussel

Brussels, Belgium

Ghent University

Ghent, Belgium

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

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

Self-reported central sensitization symptoms. Score ranges from 0 to 100, with higher scores indicating more self-reported symptoms of central sensitization.

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

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).

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

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.