Musculoskeletal PainNCT06478628
Insomnia in Patients Participating in Interdisciplinary Pain Rehabilitation
An observational study of Musculoskeletal Pain and Insomnia, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain, Insomnia
- What is being tested?
- Inpatient rehabilitation and Outpatient day rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,500 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2023to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Take part in rehabilitation for long-term pain complaints at one of the five centers
- Consented to research
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Musculoskeletal Pain, Insomnia
- Being tested
- Inpatient rehabilitation, Outpatient day rehabilitation
- Medical subject headings
- Musculoskeletal Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inpatient rehabilitationBehavioural
Inpatient multimodal rehabilitation in specialist health care
Outpatient day rehabilitationBehavioural
Multimodal rehabilitation in specialist health care with program lasting whole work days
| Study group | Role | What they receive |
|---|---|---|
| Unicare Helsefort | Patients taking part in rehabilitation due to pain at Unicare Helsefort Receives: Behavioral: Inpatient rehabilitation | |
| Unicare Hokksund | Patients taking part in rehabilitation due to pain at Unicare Hokksund Receives: Behavioral: Inpatient rehabilitation; Behavioral: Outpatient day rehabilitation | |
| Unicare Coperio | Patients taking part in rehabilitation due to pain at Unicare Coperio Receives: Behavioral: Outpatient day rehabilitation | |
| Unicare Jeløy | Patients taking part in rehabilitation due to pain at Unicare Jeløy Receives: Behavioral: Inpatient rehabilitation; Behavioral: Outpatient day rehabilitation | |
| Unicare Friskvern | Patients taking part in rehabilitation due to pain at Unicare Friskvern Receives: Behavioral: Outpatient day rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia
Measured by Insomnia severity index (ISI)
Measured: Baseline
Pain intensity
Measured by visual analogue scale (0 to 100 scale)
Measured: Baseline
Secondary outcomes (9)
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.
Measured: Baseline
Fatigue
Measured using a visual analogue scale from 0 to 100
Measured: Baseline
Function
Measured by the patient-specific functional scale (PSFS)
Measured: Baseline
Physical activity
Measured by questions from the HUNT study
Measured: Baseline
Workability
Measured by the workability index single item (self- assessed work ability on a 0-10 scale)
Measured: Baseline
Symptoms of anxiety and depression
Measured by the Hopkins Symptom Checklist-25 (HSCL-25), mean score calculated (1-4)
Measured: Baseline
Prescriptions
Use of sleep psychotropic medications, and pain medications based on registry data
Measured: Up to five years before rehabilitation and one year after rehabilitation
Sickness absence
Use of medical benefits based on registry data
Measured: Up to five years before rehabilitation and one year after rehabilitation
Health care use
Health care use in primary care based on registry data
Measured: Up to five years before rehabilitation and one year after rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Jan 2023
- Primary completion31 Jul 2025
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Unicare
- Responsible party
- Sponsor
- Investigators
- Solveig K. Grudt, Msc, Study chair, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478628
- Sponsor's protocol ID
- 547864
- Status last verified
- Jan 2026
- First submitted
- 24 Jun 2024
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insomnia in Patients Participating in Interdisciplinary Pain Rehabilitation
- ClinicalTrials.gov ID
- NCT06478628
- Acronym / sponsor ID
- 547864
- Conditions
- Musculoskeletal Pain, Insomnia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Unicare
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Unicare Helsefort | – | Behavioral: Inpatient rehabilitationPatients taking part in rehabilitation due to pain at Unicare Helsefort |
| Unicare Hokksund | – | Behavioral: Inpatient rehabilitation, Behavioral: Outpatient day rehabilitationPatients taking part in rehabilitation due to pain at Unicare Hokksund |
| Unicare Coperio | – | Behavioral: Outpatient day rehabilitationPatients taking part in rehabilitation due to pain at Unicare Coperio |
| Unicare Jeløy | – | Behavioral: Inpatient rehabilitation, Behavioral: Outpatient day rehabilitationPatients taking part in rehabilitation due to pain at Unicare Jeløy |
| Unicare Friskvern | – | Behavioral: Outpatient day rehabilitationPatients taking part in rehabilitation due to pain at Unicare Friskvern |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Take part in rehabilitation for long-term pain complaints at one of the five centers
- Consented to research
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inpatient rehabilitationInpatient multimodal rehabilitation in specialist health care | Behavioural | Unicare Helsefort, Unicare Hokksund, Unicare Jeløy |
| Outpatient day rehabilitationMultimodal rehabilitation in specialist health care with program lasting whole work days | Behavioural | Unicare Coperio, Unicare Friskvern, Unicare Hokksund, Unicare Jeløy |
Primary outcome
Insomnia
Time frame: Baseline
Measured by Insomnia severity index (ISI)
Pain intensity
Time frame: Baseline
Measured by visual analogue scale (0 to 100 scale)
9 secondary outcomes
Health-related quality of life
Time frame: Baseline
Fatigue
Time frame: Baseline
Function
Time frame: Baseline
Physical activity
Time frame: Baseline
Workability
Time frame: Baseline
Symptoms of anxiety and depression
Time frame: Baseline
Prescriptions
Time frame: Up to five years before rehabilitation and one year after rehabilitation
Sickness absence
Time frame: Up to five years before rehabilitation and one year after rehabilitation
Health care use
Time frame: Up to five years before rehabilitation and one year after rehabilitation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Solveig K. Grudt, Msc study chair
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Pain and Insomnia, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.