Insomnia in Patients Participating in Interdisciplinary Pain Rehabilitation

NCT ID: NCT06478628

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Musculoskeletal Pain Insomnia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Unicare Helsefort

Patients taking part in rehabilitation due to pain at Unicare Helsefort

Inpatient rehabilitation

Intervention Type BEHAVIORAL

Inpatient multimodal rehabilitation in specialist health care

Unicare Hokksund

Patients taking part in rehabilitation due to pain at Unicare Hokksund

Inpatient rehabilitation

Intervention Type BEHAVIORAL

Inpatient multimodal rehabilitation in specialist health care

Outpatient day rehabilitation

Intervention Type BEHAVIORAL

Multimodal rehabilitation in specialist health care with program lasting whole work days

Unicare Coperio

Patients taking part in rehabilitation due to pain at Unicare Coperio

Outpatient day rehabilitation

Intervention Type BEHAVIORAL

Multimodal rehabilitation in specialist health care with program lasting whole work days

Unicare Jeløy

Patients taking part in rehabilitation due to pain at Unicare Jeløy

Inpatient rehabilitation

Intervention Type BEHAVIORAL

Inpatient multimodal rehabilitation in specialist health care

Outpatient day rehabilitation

Intervention Type BEHAVIORAL

Multimodal rehabilitation in specialist health care with program lasting whole work days

Unicare Friskvern

Patients taking part in rehabilitation due to pain at Unicare Friskvern

Outpatient day rehabilitation

Intervention Type BEHAVIORAL

Multimodal rehabilitation in specialist health care with program lasting whole work days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Inpatient rehabilitation

Inpatient multimodal rehabilitation in specialist health care

Intervention Type BEHAVIORAL

Outpatient day rehabilitation

Multimodal rehabilitation in specialist health care with program lasting whole work days

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Unicare

UNKNOWN

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Solveig K. Grudt, Msc

Role: STUDY_CHAIR

National Taiwan Normal University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Unicare Helsefort

Rissa, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

547864

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

3h of PNE on BDNF and Pain Levels
NCT05736172 RECRUITING NA