Insomnia in Patients Participating in Interdisciplinary Pain Rehabilitation

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Musculoskeletal Pain; Insomnia
• Intervention / Treatment: Behavioral: Inpatient rehabilitation; Behavioral: Outpatient day rehabilitation

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 Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

Study Locations

• Norway
  • Rissa, Norway, 7112 Hasselvika
    • Unicare Helsefort

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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. Potential participants are referred to outpatient or inpatient rehabilitation or a shorter assessment stay (where the goal is to assess what is the best treatment option for the patient). Referrals to the rehabilitation centers are done by the patients' general practitioner or by specialist healthcare. All referrals are considered at the regional unit for referrals (Regionalt henvisningsmottatak) in mid- or southeast Norway who judge whether they fulfill the criteria for rehabilitation in specialist health care.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Unicare Helsefort; Patients taking part in rehabilitation due to pain at Unicare Helsefort	Behavioral: Inpatient rehabilitation; Inpatient multimodal rehabilitation in specialist health care
Unicare Hokksund; Patients taking part in rehabilitation due to pain at Unicare Hokksund	Behavioral: Inpatient rehabilitation; Inpatient multimodal rehabilitation in specialist health care; Behavioral: Outpatient day rehabilitation; 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	Behavioral: Outpatient day rehabilitation; 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	Behavioral: Inpatient rehabilitation; Inpatient multimodal rehabilitation in specialist health care; Behavioral: Outpatient day rehabilitation; 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	Behavioral: Outpatient day rehabilitation; Multimodal rehabilitation in specialist health care with program lasting whole work days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia	Measured by Insomnia severity index (ISI)	Baseline
Pain intensity	Measured by visual analogue scale (0 to 100 scale)	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	Measured using a visual analogue scale from 0 to 100	Baseline
Function	Measured by the patient-specific functional scale (PSFS)	Baseline
Physical activity	Measured by questions from the HUNT study	Baseline
Workability	Measured by the workability index single item (self- assessed work ability on a 0-10 scale)	Baseline
Prescriptions	Use of sleep psychotropic medications, and pain medications based on registry data	Up to five years before rehabilitation and one year after rehabilitation
Sickness absence	Use of medical benefits based on registry data	Up to five years before rehabilitation and one year after rehabilitation
Health care use	Health care use in primary care based on registry data	Up to five years before rehabilitation and one year after rehabilitation
Health-related quality of life	Measured by the the 5-level EQ-5D version (EQ-5D-5L) questionnaire. The index value range ranges from -0.285 to 1, where lower values indicate poorer health-related quality of life.	Baseline
Symptoms of anxiety and depression	Measured by the Hopkins Symptom Checklist-25 (HSCL-25), mean score calculated (1-4)	Baseline

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Unicare
• Investigators: Study Chair: Solveig K. Grudt, Msc, National Taiwan Normal University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): July 31, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Musculoskeletal Pain; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 547864

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No