An interventional study of Accelerometry in Chronic Pain, Insomnia and Exercise, sponsored by Göteborg University. Status unknown at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-02.
Sponsored by Göteborg University · Not applicable, Interventional, and Screening
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.
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's planned enrollment of 100 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
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Exclusion Criteria:
Recording of sleep and physical activity by accelerometry during one week.
Device: Accelerometry
Recording of sleep and physical activity by accelerometry during one week.
Sleep
Sleep duration in minutes assessed by accelerometry
Time frame: Daily assessment during one week
Sleep
Sleep timing, i.e. sleep onset and wake time assessed by accelerometry
Time frame: Daily assessment during one week
Physical activity
Minutes of physical activity per week at moderate and vigorous intensity physical activity (MVPA), minutes of sedentary behaviour (SED) assessed by accelerometry
Time frame: Daily assessment during one week
Opioid consumption
Opioid consumption in morphine equivalent doses
Time frame: Opioid consumption at study enrollment
Pain intensity
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"
Time frame: Daily assessment during one week
Insomnia Severity
Total Score from the 7-item Insomnia Severity Index where total score ranges from 0-28 and higher scores indicate greater severity of insomnia.
Time frame: Insomnia severity at enrollment
Sleep quality
Assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 self-rated questions which assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep related problems. The 19 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The seven component score are then summed to yield a global PSQI score which has a range of 0-21; higher scores indicate worse sleep quality.
Time frame: Sleep quality at study enrollment
Daytime sleepiness
Epworth Sleepiness Scale (ESS), which quantifies daytime sleepiness. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher daytime sleepiness.
Time frame: Daytime sleepiness at study enrollment
Self-assessed physical activity
Minutes of physical activity per week (physical exercise and daily exercise) and minutes of sedentary behaviour per week.
Time frame: Self-assessed physical activity at study enrollment
Self-efficacy for exercise scale
The Self-efficacy for exercise scale measures a patient's self-efficacy when it comes to physical exercise. The questionnaire consists of 9 questions that can be answered on a 1-10 scale. A total score between 9 and 90 is calculated, were a higher number represent a better outcome.
Time frame: Self-efficacy for exercise at study enrollment
Mental fatigue scale
The mental fatigue scale (MFS) is a multidimensional questionnaire containing 15 questions. A total score between 0-42 is calculated. A score \>10 indicates a problem with mental fatigue.
Time frame: Mental fatigue at study enrollment
Sleep dairy
Self-assessed sleep latency, total sleep time, wake time after sleep onset and sleep quality.
Time frame: Daily assessment during one week
Neurofilament light
Neurofilament light in blood sample
Time frame: Neurofilament light at study enrollment
25-hydroxyvitamin D
Levels of Serum 25-hydroxyvitamin D (25\[OH\]D)
Time frame: 25-hydroxyvitamin D at study enrollment
Plan to share: No
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This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Göteborg University