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Clinical Trials/NCT06478628
NCT06478628Enrolling By InvitationNot Applicable

Insomnia in Patients Participating in Interdisciplinary Pain Rehabilitation

Norwegian University of Science and Technology1 site in 1 country1,500 target enrollmentStarted: January 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
1,500
Locations
1
Primary Endpoint
Insomnia

Study Overview

Brief Summary

The main purpose of this project is to conduct a prospective cohort study in order to better understand the importance of insomnia symptoms in patients referred to interdisciplinary rehabilitation due to chronic pain. Moreover, this project will also raise awareness on how insomnia symptoms, alone, and in interplay with factors such as function, psychological distress, physical activity, and fatigue impact on patient's prognosis and work ability. Our aim is that this knowledge can be used to design new interventions and improve rehabilitation programs for this patient group.

Detailed Description

Insomnia is a vast problem among patients with chronic musculoskeletal pain. Despite the close relation between pain and sleep, sleep quality has received little attention in rehabilitation programs for patients with pain. So far, there is a lack of studies investigating the association between insomnia and chronic pain in patients referred to interdisciplinary rehabilitation. Identifying subgroups of the population with higher burden of poor sleep will aid clinicians to tailor treatment and prevention strategies. Moreover, knowledge on how insomnia symptoms fluctuate throughout the rehabilitation program and how insomnia symptoms interact with factors such as mental distress, physical activity, and fatigue impact on patient's recovery (e.g., the prognosis of pain, quality of life, and work participation) can be used to develop and implement more successful rehabilitation programs.

This is a cohort study primarily designed to address sleep problems in patients referred for pain rehabilitation by using questionnaire data from the rehabilitation centers linked to registry data. This study will constitute both a cross-sectional survey among patients referred to rehabilitation before they participate in rehabilitation. In addition to questionnaires, administrative data and clinical data, these data will be linked to national health registries on prescriptions, health care use and sickness absence. Potential participants are patients referred to rehabilitation at five different Unicare rehabilitation centers in Norway (Unicare Helsefort, Unicare Coperio, Unicare Hokksund, Unicare Friskvern and Unicare Jeløy) due to long-term pain complaints.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Take part in rehabilitation for long-term pain complaints at one of the five centers
  • Consented to research

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Insomnia

Time Frame: Baseline

Measured by Insomnia severity index (ISI)

Pain intensity

Time Frame: Baseline

Measured by visual analogue scale (0 to 100 scale)

Secondary Outcomes

  • Symptoms of anxiety and depression(Baseline)
  • Function(Baseline)
  • Health care use(Up to five years before rehabilitation and one year after rehabilitation)
  • Workability(Baseline)
  • Prescriptions(Up to five years before rehabilitation and one year after rehabilitation)
  • Sickness absence(Up to five years before rehabilitation and one year after rehabilitation)
  • Fatigue(Baseline)
  • Health-related quality of life(Baseline)
  • Physical activity(Baseline)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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