Insomnia and Sleep Disturbances in Chronic Pain Patients - Relation to Physical Activity Level and Opioid Use

Chronic Pain Clinical Trial

Official title:

Insomnia and Sleep Disturbances in Chronic Pain Patients - Relation to Physical Activity Level and Opioid Use

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04649281
• Other study ID #: 272924
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2020
• Source: Göteborg University
• Contact: Paulin Andréll, MD, PhD
• Phone: +46-31-3438259
• Email: paulin.andrell[@]gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Dyssomnias
• Exercise
• Insomnia
• Opioid Use
• Parasomnias
• Sleep
• Sleep Disorder
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

Intervention

Device:
• Accelerometry
Recording of sleep and physical activity by accelerometry during one week.

Locations

Country	Name	City	State
Sweden	Pain Centre, Department of Anaesthesiology and Intensive Care Medicine Östra, Sahlgrenska University Hospital, Region Västra Götaland	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neurofilament light	Neurofilament light in blood sample	Neurofilament light at study enrollment
Other	25-hydroxyvitamin D	Levels of Serum 25-hydroxyvitamin D (25[OH]D)	25-hydroxyvitamin D at study enrollment
Primary	Sleep	Sleep duration in minutes assessed by accelerometry	Daily assessment during one week
Primary	Sleep	Sleep timing, i.e. sleep onset and wake time assessed by accelerometry	Daily assessment during one week
Primary	Physical activity	Minutes of physical activity per week at moderate and vigorous intensity physical activity (MVPA), minutes of sedentary behaviour (SED) assessed by accelerometry	Daily assessment during one week
Primary	Opioid consumption	Opioid consumption in morphine equivalent doses	Opioid consumption at study enrollment
Primary	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"	Daily assessment during one week
Secondary	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.	Insomnia severity at enrollment
Secondary	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.	Sleep quality at study enrollment
Secondary	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.	Daytime sleepiness at study enrollment
Secondary	Self-assessed physical activity	Minutes of physical activity per week (physical exercise and daily exercise) and minutes of sedentary behaviour per week.	Self-assessed physical activity at study enrollment
Secondary	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.	Self-efficacy for exercise at study enrollment
Secondary	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.	Mental fatigue at study enrollment
Secondary	Sleep dairy	Self-assessed sleep latency, total sleep time, wake time after sleep onset and sleep quality.	Daily assessment during one week