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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04598373
Other study ID # Dalarna University
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2009
Est. completion date December 2016

Study information

Verified date October 2020
Source Dalarna University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 coordinated in an interdisciplinary team. Based on data from Swedish National Registers, this study evaluates the effects of IDT on sickness absence.


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).


Recruitment information / eligibility

Status Completed
Enrollment 25000
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
interdisciplinary treatment
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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Dalarna University Forte, The Swedish Research Council

Outcome

Type Measure Description Time frame Safety issue
Primary Sickness absence Length of stay per sickness absence state: no sickness absence, sick leave, disability pension 5 years
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