Clinical trial NCT04649281: Insomnia and Sleep Disturbances in Chronic Pain Patients - Relation to Physical Activity Level and Opioid Use
Official title: Insomnia and Sleep Disturbances in Chronic Pain Patients - Relation to Physical Activity Level and Opioid Use
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Insomnia
Exercise
Sleep
Sleep Disorder
Opioid Use
Keywords: Accelerometry
Mental fatigue
Self-Efficacy
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
First posted: 2020-12-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Pain is one of the most common causes of healthcare contact and long-term sick leave, with negative consequences on physical and mental health. Poor sleep is common in chronic pain patients. Epidemiological studies indicate that 5-7% of patients with chronic pain are treated regularly with strong opioids. Negative side effects of pain modulating drugs on sleep quality have been reported, which may have negative influence on overall disease management in chronic pain patients. However, to date there are conflicting results regarding the effects of opioids on sleep, since the pain relieving effect of opioids seem to affect sleep positively. There is data suggesting that physical activity has positive effects on both pain perception and sleep quality (and duration). The aim of the study is to explore insomnia and characteristics of sleep in patients with chronic pain and the relationship with physical activity level and opioid use.

Detailed description: One hundred participants with planned follow-up (decision according to clinical routine) at the Pain Centre will be consecutively recruited. After signed informed consent, the participants will wear two accelerometers during one week, one for recording sleep and one for recording physical activity. The participants will be asked to fill out a sleep and pain diary during the same week. Furthermore, the participants will fill out questionnaires regarding sleep, life style, mental fatigue and self-efficacy. All study participant are included in the Swedish Quality Registry for Pain Rehabilitation (SQRP). Data from the SQRP will be used regarding patient health characteristics, pain and pain associated symptoms, health related quality of life, sleep and self-reported physical activity level. Data regarding co-morbidity, drug use, pharmacological treatment and other interventions at the Pain Center will be collected from the patient charts. In addition, the participants blood pressure and neck circumference will be measured. Blood samples will be analysed for biomarkers associated with pain and sleep disturbance.

Eligibility criteria: Inclusion Criteria:

* Chronic pain (i.e. pain \> 3 months)
* Planned follow up at the Pain Centre
* Age ≥18 years
* Consents to participation in the study

Exclusion Criteria:

* Inadequate knowledge of the Swedish language
* Alcohol or substance abuse
* Severe untreated psychiatric disorders including psychiatric disease and/or psychological conditions which are the primary determinant to the patient's pain condition
* Malignant disease with short expected survival

Primary outcomes:
measure: Sleep
timeFrame: Daily assessment during one week
measure: Sleep
timeFrame: Daily assessment during one week
measure: Physical activity
timeFrame: Daily assessment during one week
measure: Opioid consumption
timeFrame: Opioid consumption at study enrollment
measure: Pain intensity
timeFrame: Daily assessment during one week
Secondary outcomes:
measure: Insomnia Severity
timeFrame: Insomnia severity at enrollment
measure: Sleep quality
timeFrame: Sleep quality at study enrollment
measure: Daytime sleepiness
timeFrame: Daytime sleepiness at study enrollment
measure: Self-assessed physical activity
timeFrame: Self-assessed physical activity at study enrollment
measure: Self-efficacy for exercise scale
timeFrame: Self-efficacy for exercise at study enrollment
measure: Mental fatigue scale
timeFrame: Mental fatigue at study enrollment
measure: Sleep dairy
timeFrame: Daily assessment during one week
Other outcomes:
measure: Neurofilament light
timeFrame: Neurofilament light at study enrollment
measure: 25-hydroxyvitamin D
timeFrame: 25-hydroxyvitamin D at study enrollment
Locations:
city: Gothenburg
country: Sweden
facility: Pain Centre, Department of Anaesthesiology and Intensive Care Medicine Östra, Sahlgrenska University Hospital, Region Västra Götaland
Study officials:
affiliation: Sahlgrenska University Hospital, Region Västra Götaland; Göteborg University
name: Paulin Andréll, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: