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Insomnia in Patients Participating in Interdisciplinary Pain Rehabilitation

Insomnia in Patients Participating in Interdisciplinary Pain Rehabilitation

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06478628
Enrollment
1500
Registered
2024-06-27
Start date
2023-01-01
Completion date
2026-07-31
Last updated
2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Musculoskeletal Pain

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.

Interventions

Inpatient multimodal rehabilitation in specialist health care

BEHAVIORALOutpatient day rehabilitation

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

Sponsors

Unicare
CollaboratorUNKNOWN
Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
InsomniaBaselineMeasured by Insomnia severity index (ISI)
Pain intensityBaselineMeasured by visual analogue scale (0 to 100 scale)

Secondary

MeasureTime frameDescription
Health-related quality of lifeBaselineMeasured 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.
FatigueBaselineMeasured using a visual analogue scale from 0 to 100
FunctionBaselineMeasured by the patient-specific functional scale (PSFS)
Sickness absenceUp to five years before rehabilitation and one year after rehabilitationUse of medical benefits based on registry data
WorkabilityBaselineMeasured by the workability index single item (self- assessed work ability on a 0-10 scale)
Symptoms of anxiety and depressionBaselineMeasured by the Hopkins Symptom Checklist-25 (HSCL-25), mean score calculated (1-4)
PrescriptionsUp to five years before rehabilitation and one year after rehabilitationUse of sleep psychotropic medications, and pain medications based on registry data
Physical activityBaselineMeasured by questions from the HUNT study
Health care useUp to five years before rehabilitation and one year after rehabilitationHealth care use in primary care based on registry data

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026