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Enrolling by Invitation

NCT Number: NCT06478628

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Unicare Helsefort

Rissa, 7112 Hasselvika, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Inpatient rehabilitation

Behavioral

Inpatient multimodal rehabilitation in specialist health care

Outpatient day rehabilitation

Behavioral

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

Primary outcomes

  1. Insomnia

    Time frame: Baseline

    Measured by Insomnia severity index (ISI)

  2. Pain intensity

    Time frame: Baseline

    Measured by visual analogue scale (0 to 100 scale)

Secondary outcomes

  1. Health-related quality of life

    Time frame: 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.

  2. Fatigue

    Time frame: Baseline

    Measured using a visual analogue scale from 0 to 100

  3. Function

    Time frame: Baseline

    Measured by the patient-specific functional scale (PSFS)

  4. Physical activity

    Time frame: Baseline

    Measured by questions from the HUNT study

  5. Workability

    Time frame: Baseline

    Measured by the workability index single item (self- assessed work ability on a 0-10 scale)

  6. Symptoms of anxiety and depression

    Time frame: Baseline

    Measured by the Hopkins Symptom Checklist-25 (HSCL-25), mean score calculated (1-4)

  7. Prescriptions

    Time frame: Up to five years before rehabilitation and one year after rehabilitation

    Use of sleep psychotropic medications, and pain medications based on registry data

  8. Sickness absence

    Time frame: Up to five years before rehabilitation and one year after rehabilitation

    Use of medical benefits based on registry data

  9. Health care use

    Time frame: Up to five years before rehabilitation and one year after rehabilitation

    Health care use in primary care based on registry data

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Unicare

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 27, 2024
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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