- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04598373
Effects of Interdisciplinary Treatment on Sickness Absence in Patients With Chronic Pain
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- IDT startyear: 2009-2016
- Age 18-60 yeras
- Pain duration of minimum 90 days
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
IDT patients
Allocated to an IDT program
|
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.
Other Names:
|
|
Non-IDT patients
Not allocated to an IDT program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sickness absence
Time Frame: 5 years
|
Length of stay per sickness absence state: no sickness absence, sick leave, disability pension
|
5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dalarna University
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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