Insomnia and Sleep Disturbances in Chronic Pain Patients - Relation to Physical Activity Level and Opioid Use
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Physical activity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Physical activity
Time Frame: Daily assessment during one week
Minutes of physical activity per week at moderate and vigorous intensity physical activity (MVPA), minutes of sedentary behaviour (SED) assessed by accelerometry
Opioid consumption
Time Frame: Opioid consumption at study enrollment
Opioid consumption in morphine equivalent doses
Pain intensity
Time Frame: Daily assessment during one week
Pain intensity according to Numeric Rating Scale (NRS), score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable"
Sleep
Time Frame: Daily assessment during one week
Sleep duration in minutes assessed by accelerometry
Secondary Outcomes
- Insomnia Severity(Insomnia severity at enrollment)
- Sleep quality(Sleep quality at study enrollment)
- Self-assessed physical activity(Self-assessed physical activity at study enrollment)
- Mental fatigue scale(Mental fatigue at study enrollment)
- Daytime sleepiness(Daytime sleepiness at study enrollment)
- Self-efficacy for exercise scale(Self-efficacy for exercise at study enrollment)
- Sleep dairy(Daily assessment during one week)