Insomnia and Sleep Disturbances in Chronic Pain Patients - Relation to Physical Activity Level and Opioid Use
Primary Purpose
Chronic Pain, Insomnia, Exercise
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Accelerometry
Sponsored by
About this trial
This is an interventional screening trial for Chronic Pain focused on measuring Accelerometry, Mental fatigue, Self-Efficacy
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
Sites / Locations
- Pain Centre, Department of Anaesthesiology and Intensive Care Medicine Östra, Sahlgrenska University Hospital, Region Västra GötalandRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Accelerometry
Arm Description
Recording of sleep and physical activity by accelerometry during one week.
Outcomes
Primary Outcome Measures
Sleep
Sleep duration in minutes assessed by accelerometry
Sleep
Sleep timing, i.e. sleep onset and wake time assessed by accelerometry
Physical activity
Minutes of physical activity per week at moderate and vigorous intensity physical activity (MVPA), minutes of sedentary behaviour (SED) assessed by accelerometry
Opioid consumption
Opioid consumption in morphine equivalent doses
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"
Secondary Outcome Measures
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.
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.
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.
Self-assessed physical activity
Minutes of physical activity per week (physical exercise and daily exercise) and minutes of sedentary behaviour per week.
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.
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.
Sleep dairy
Self-assessed sleep latency, total sleep time, wake time after sleep onset and sleep quality.
Full Information
NCT ID
NCT04649281
First Posted
October 28, 2020
Last Updated
November 30, 2020
Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region
1. Study Identification
Unique Protocol Identification Number
NCT04649281
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 12, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Insomnia, Exercise, Sleep, Sleep Disorder, Opioid Use
Keywords
Accelerometry, Mental fatigue, Self-Efficacy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Accelerometry
Arm Type
Other
Arm Description
Recording of sleep and physical activity by accelerometry during one week.
Intervention Type
Device
Intervention Name(s)
Accelerometry
Intervention Description
Recording of sleep and physical activity by accelerometry during one week.
Primary Outcome Measure Information:
Title
Sleep
Description
Sleep duration in minutes assessed by accelerometry
Time Frame
Daily assessment during one week
Title
Sleep
Description
Sleep timing, i.e. sleep onset and wake time assessed by accelerometry
Time Frame
Daily assessment during one week
Title
Physical activity
Description
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
Title
Opioid consumption
Description
Opioid consumption in morphine equivalent doses
Time Frame
Opioid consumption at study enrollment
Title
Pain intensity
Description
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
Secondary Outcome Measure Information:
Title
Insomnia Severity
Description
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
Title
Sleep quality
Description
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
Title
Daytime sleepiness
Description
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
Title
Self-assessed physical activity
Description
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
Title
Self-efficacy for exercise scale
Description
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
Title
Mental fatigue scale
Description
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
Title
Sleep dairy
Description
Self-assessed sleep latency, total sleep time, wake time after sleep onset and sleep quality.
Time Frame
Daily assessment during one week
Other Pre-specified Outcome Measures:
Title
Neurofilament light
Description
Neurofilament light in blood sample
Time Frame
Neurofilament light at study enrollment
Title
25-hydroxyvitamin D
Description
Levels of Serum 25-hydroxyvitamin D (25[OH]D)
Time Frame
25-hydroxyvitamin D at study enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paulin Andréll, MD, PhD
Phone
+46-31-3438259
Email
paulin.andrell@gu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Olsson, MD
Phone
+46-31-3435816
Email
martin.olsson@gu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulin Andréll, MD, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Region Västra Götaland; Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain Centre, Department of Anaesthesiology and Intensive Care Medicine Östra, Sahlgrenska University Hospital, Region Västra Götaland
City
Gothenburg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulin Andréll, MD, PhD
First Name & Middle Initial & Last Name & Degree
Martin Olsson, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Insomnia and Sleep Disturbances in Chronic Pain Patients - Relation to Physical Activity Level and Opioid Use
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