Insomnia in Patients Participating in Interdisciplinary Pain Rehabilitation

NCT06478628 | Enrolling By Invitation

• 1 other identifier: 547864
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain; Insomnia

Outcome Measures

Primary Outcomes (2)

• Insomnia

  Measured by Insomnia severity index (ISI)

  Baseline

• Pain intensity

  Measured by visual analogue scale (0 to 100 scale)

  Baseline

Secondary Outcomes (9)

• Health-related quality of life

  Baseline

• Fatigue

  Baseline

• Function

  Baseline

• Physical activity

  Baseline

• Workability

  Baseline

Study Arms (5)

Unicare Helsefort

Patients taking part in rehabilitation due to pain at Unicare Helsefort

Behavioral: Inpatient rehabilitation

Unicare Hokksund

Patients taking part in rehabilitation due to pain at Unicare Hokksund

Behavioral: Inpatient rehabilitation; Behavioral: Outpatient day rehabilitation

Unicare Coperio

Patients taking part in rehabilitation due to pain at Unicare Coperio

Behavioral: Outpatient day rehabilitation

Unicare Jeløy

Patients taking part in rehabilitation due to pain at Unicare Jeløy

Behavioral: Inpatient rehabilitation; Behavioral: Outpatient day rehabilitation

Unicare Friskvern

Patients taking part in rehabilitation due to pain at Unicare Friskvern

Behavioral: Outpatient day rehabilitation

Interventions

Inpatient rehabilitation BEHAVIORAL

Inpatient multimodal rehabilitation in specialist health care

Unicare Helsefort; Unicare Hokksund; Unicare Jeløy

Outpatient day rehabilitation BEHAVIORAL

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

Unicare Coperio; Unicare Friskvern; Unicare Hokksund; Unicare Jeløy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• Unicare: collaborator

Study Sites (1)

Unicare Helsefort

Rissa, 7112 Hasselvika, Norway

Location

MeSH Terms

Conditions

Musculoskeletal Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Solveig K. Grudt, Msc

  National Taiwan Normal University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 27, 2024
• Study Start: January 1, 2023
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

NO (1)