Insomnia in Patients Participating in Interdisciplinary Pain Rehabilitation

• Conditions: Insomnia; Musculoskeletal Pain
• Interventions: Behavioral: Inpatient rehabilitation; Behavioral: Outpatient day rehabilitation

• Registration Number: NCT06478628
• Lead Sponsor: Norwegian University of Science and Technology

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 Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2024-06-24
• Study First Submitted QC: 2024-06-24
• Study First Posted: 2024-06-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-05
• Last Update Posted: 2024-07-08
• Primary Completion: 2025-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Unicare Hokksund	Inpatient rehabilitation	Patients taking part in rehabilitation due to pain at Unicare Hokksund
Unicare Coperio	Outpatient day rehabilitation	Patients taking part in rehabilitation due to pain at Unicare Coperio
Unicare Helsefort	Inpatient rehabilitation	Patients taking part in rehabilitation due to pain at Unicare Helsefort
Unicare Jeløy	Inpatient rehabilitation	Patients taking part in rehabilitation due to pain at Unicare Jeløy
Unicare Hokksund	Outpatient day rehabilitation	Patients taking part in rehabilitation due to pain at Unicare Hokksund
Unicare Friskvern	Outpatient day rehabilitation	Patients taking part in rehabilitation due to pain at Unicare Friskvern
Unicare Jeløy	Outpatient day rehabilitation	Patients taking part in rehabilitation due to pain at Unicare Jeløy

Primary Outcome Measures

Name	Time	Method
Insomnia	Baseline	Measured by Insomnia severity index (ISI)
Pain intensity	Baseline	Measured by visual analogue scale (0 to 100 scale)

Secondary Outcome Measures

Name	Time	Method
Symptoms of anxiety and depression	Baseline	Measured by the Hopkins Symptom Checklist-25 (HSCL-25), mean score calculated (1-4)
Function	Baseline	Measured by the patient-specific functional scale (PSFS)
Health care use	Up to five years before rehabilitation and one year after rehabilitation	Health care use in primary care based on registry data
Workability	Baseline	Measured by the workability index single item (self- assessed work ability on a 0-10 scale)
Prescriptions	Up to five years before rehabilitation and one year after rehabilitation	Use of sleep psychotropic medications, and pain medications based on registry data
Fatigue	Baseline	Measured using a visual analogue scale from 0 to 100
Sickness absence	Up to five years before rehabilitation and one year after rehabilitation	Use of medical benefits based on registry data
Health-related quality of life	Baseline	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.
Physical activity	Baseline	Measured by questions from the HUNT study

Trial Locations

Locations (1)

Unicare Helsefort; 🇳🇴 Rissa, Norway