Chronic PainNCT04598373
Effects of Interdisciplinary Treatment on Sickness Absence in Patients With Chronic Pain
An observational study of Chronic Pain, run by Dalarna University.
Trial summary
Chronic pain is a globally prevalent condition that causes enormous social costs; largely due to sickness absence. A common intervention for patients with chronic pain problems is interdisciplinary treatment (IDT), which consists of a combination of physical exercise, cognitive behavioural therapy and work training… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- interdisciplinary treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 25,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients that visited a Swedish SQRP-affiliated IDT specialist clinic.
Who may be able to join
- IDT startyear: 2009-2016
- Age 18-60 yeras
- Pain duration of minimum 90 days
Who cannot join
- Cancer in the previous 5 years
- An IDT assessment in the previous 2 years
- Full or partial disability pension in the year preceding the IDT assessment
About this study
Chronic pain is a globally prevalent condition that causes enormous social costs; largely due to sickness absence. A common intervention for patients with chronic pain problems is interdisciplinary treatment (IDT), which consists of a combination of physical exercise, cognitive behavioural therapy and work training coordinated in an interdisciplinary team. Based on data from Swedish National Registers, this study evaluates the effects of IDT on sickness absence.
Read the detailed description
This is a completely register-based observational cohort study. The study population is defined from the Swedish Quality Registry for Pain Rehabilitation (SQRP), which routinely aggregates data from specialist IDT pain management clinics across Sweden. SQRP contains information on the exposure/intervention: whether a patient that visited a SQRP-affiliated clinic was allocated to an IDT program (test) or not (control); t0 defined as the day of the IDT assessment. Microdata from SQRP is linked to other Swedish registers via the unique personal identification number held by all Swedish residents. Outcome data is obtained from the Swedish Social Insurance Agency. Registers managed by the National Board of Health and Welfare include data on dispensed prescription pharmaceuticals and specialist health care.
Markov multistate survival-based methods will be used to compare the sickness absence between groups. Specifically, length of stay per sickness absence state (no sickness absence, sick leave, and disability pension) will be compared over five years from t0. Both crude and adjusted estimates will be presented. Adjustment will be made based on our hypothesis about causal relationships and include: history of sickness absence, sociodemographics (age, sex, sociodemographic status), patient disability (emotional distress, everyday interference, and confidence in future improvement), and governmental policy (IDT assessment year and geographical region of IDT clinic).
- Conditions
- Chronic Pain
- Being tested
- interdisciplinary treatment
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interdisciplinary treatmentBehavioural
Also called multimodal rehabilitation
Interdisciplinary treatment (IDT) distinguishes itself as an interdisciplinary-coordinated (e.g., physician, occupational therapist, physiotherapist, and psychologist) intervention using a bio-psycho-social view of chronic pain. The MMR continues over a lengthy period with a common goal and generally includes patient education, supervised physical activity, simulated work training, and cognitive behavioural therapy (CBT). The exact composition of these MMR components depends on initial evaluations of the patients health status and furhter follow-up testing. The MMR interventional components can act independently and interdependently, resulting in combined effects due to known and unknown mechanisms; the effects are intended to be greater than the sum of its components.
| Study group | Role | What they receive |
|---|---|---|
| IDT patients | Allocated to an IDT program Receives: Behavioral: interdisciplinary treatment | |
| Non-IDT patients | Not allocated to an IDT program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sickness absence
Length of stay per sickness absence state: no sickness absence, sick leave, disability pension
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study startJan 2009
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- 25,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalarna University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Forte
- Responsible party
- Principal investigator, Bjorn Ang, Dalarna University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598373
- Sponsor's protocol ID
- Dalarna University
- Status last verified
- Oct 2020
- First submitted
- 16 Oct 2020
- Last updated
- 22 Oct 2020
- 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 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Interdisciplinary Treatment on Sickness Absence in Patients With Chronic Pain
- ClinicalTrials.gov ID
- NCT04598373
- Acronym / sponsor ID
- Dalarna University
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25,000 participants (actual)
- Lead sponsor
- Dalarna UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Forte
- Study start
- Jan 2009 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Oct 2020 (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.
Chronic pain is a globally prevalent condition that causes enormous social costs; largely due to sickness absence. A common intervention for patients with chronic pain problems is interdisciplinary treatment (IDT), which consists of a combination of physical exercise, cognitive behavioural therapy and work training coordinated in an interdisciplinary team. Based on data from Swedish National Registers, this study evaluates the effects of IDT on sickness absence.
Detailed description
This is a completely register-based observational cohort study. The study population is defined from the Swedish Quality Registry for Pain Rehabilitation (SQRP), which routinely aggregates data from specialist IDT pain management clinics across Sweden. SQRP contains information on the exposure/intervention: whether a patient that visited a SQRP-affiliated clinic was allocated to an IDT program (test) or not (control); t0 defined as the day of the IDT assessment. Microdata from SQRP is linked to other Swedish registers via the unique personal identification number held by all Swedish residents. Outcome data is obtained from the Swedish Social Insurance Agency. Registers managed by the National Board of Health and Welfare include data on dispensed prescription pharmaceuticals and specialist health care.
Markov multistate survival-based methods will be used to compare the sickness absence between groups. Specifically, length of stay per sickness absence state (no sickness absence, sick leave, and disability pension) will be compared over five years from t0. Both crude and adjusted estimates will be presented. Adjustment will be made based on our hypothesis about causal relationships and include: history of sickness absence, sociodemographics (age, sex, sociodemographic status), patient disability (emotional distress, everyday interference, and confidence in future improvement), and governmental policy (IDT assessment year and geographical region of IDT clinic).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDT patients | – | Behavioral: interdisciplinary treatmentAllocated to an IDT program |
| Non-IDT patients | – | –Not allocated to an IDT program |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients that visited a Swedish SQRP-affiliated IDT specialist clinic.
Key inclusion criteria (3 listed)
- IDT startyear: 2009-2016
- Age 18-60 yeras
- Pain duration of minimum 90 days
Key exclusion criteria (3 listed)
- Cancer in the previous 5 years
- An IDT assessment in the previous 2 years
- Full or partial disability pension in the year preceding the IDT assessment
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 |
|---|---|---|
| interdisciplinary treatmentAlso: multimodal rehabilitationInterdisciplinary treatment (IDT) distinguishes itself as an interdisciplinary-coordinated (e.g., physician, occupational therapist, physiotherapist, and psychologist) intervention using a bio-psycho-social view of chronic pain. The MMR continues over a lengthy period with a common goal and generally includes patient education, supervised physical activity, simulated work training, and cognitive behavioural therapy (CBT). The exact composition of these MMR components depends on initial evaluations of the patients health status and furhter follow-up testing. The MMR interventional components can act independently and interdependently, resulting in combined effects due to known and unknown mechanisms; the effects are intended to be greater than the sum of its components. | Behavioural | IDT patients |
Primary outcome
Sickness absence
Time frame: 5 years
Length of stay per sickness absence state: no sickness absence, sick leave, disability pension
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Dalarna University.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sickness absence (time frame: 5 years). 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 22 Oct 2020.