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

NCT04649281 | Unknown

• 1 other identifier: 272924
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Insomnia; Exercise; Sleep; Sleep Disorder; Opioid Use

Keywords

Accelerometry; Mental fatigue; Self-Efficacy

Outcome Measures

Primary Outcomes (5)

• Sleep

  Sleep duration in minutes assessed by accelerometry

  Daily assessment during one week

• Sleep

  Sleep timing, i.e. sleep onset and wake time assessed by accelerometry

  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

  Daily assessment during one week

• Opioid consumption

  Opioid consumption in morphine equivalent doses

  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"

  Daily assessment during one week

Secondary Outcomes (7)

• Insomnia Severity

  Insomnia severity at enrollment

• Sleep quality

  Sleep quality at study enrollment

• Daytime sleepiness

  Daytime sleepiness at study enrollment

• Self-assessed physical activity

  Self-assessed physical activity at study enrollment

• Self-efficacy for exercise scale

  Self-efficacy for exercise at study enrollment

Other Outcomes (2)

• Neurofilament light

  Neurofilament light at study enrollment

• 25-hydroxyvitamin D

  25-hydroxyvitamin D at study enrollment

Study Arms (1)

Accelerometry

OTHER

Recording of sleep and physical activity by accelerometry during one week.

Device: Accelerometry

Interventions

Accelerometry DEVICE

Recording of sleep and physical activity by accelerometry during one week.

Accelerometry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Göteborg University: lead
• Vastra Gotaland Region: collaborator

Study Sites (1)

Pain Centre, Department of Anaesthesiology and Intensive Care Medicine Östra, Sahlgrenska University Hospital, Region Västra Götaland

Gothenburg, Sweden

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Sleep Initiation and Maintenance Disorders; Motor Activity; Sleep Wake Disorders; Mental Fatigue

Interventions

Accelerometry

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Behavior; Fatigue; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Paulin Andréll, MD, PhD

  Sahlgrenska University Hospital, Region Västra Götaland; Göteborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulin Andréll, MD, PhD

CONTACT

+46-31-3438259; paulin.andrell@gu.se

Martin Olsson, MD

CONTACT

+46-31-3435816; martin.olsson@gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: December 2, 2020
• Study Start: October 12, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 2, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)