Clinical trial NCT04657159: Health-economic Evaluation of Interventional Pain Management Compared to Pain Rehabilitation
Official title: Health-economic Evaluation of Interventional Pain Management Compared to Pain Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Eques Indolor AB
Sponsor class: OTHER
Collaborators: name: Umeå University
First posted: 2020-12-08
Enrollment: 15611
Sex: ALL
Minimum age (years): 18
Maximum age (years): 94
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that have been treated with pain rehabilitation programs and that have been registered prospectively in the national register for pain rehabilitation in Sweden

Brief summary: The overall aim of the study is to evaluate interventional pain management. This is done in three steps:

1. To find matched controls to the patients in the study on cost-effectiveness of IPM and compare the results.
2. To calculate cost-effectiveness of PRP during the period 2010-2016, on a national level.
3. To calculate cost-effectiveness of PRP during the period 2017-2019, after the changed guidelines for PRP in Sweden.

The two last steps are to provide a background to the results of IPM, and to see if the results in the subgroup of matched controls of PRP-patients differ from the results from the whole population.

Detailed description: Chronic pain is one of the major health problems globally, according to the WHO 'global burden of disease' studies. Previously, the investigators have performed a study on a feasible approach to be able to treat zygapophyseal joint pain in the thoracic region, similar to the established methods for treatment in the lumbar and cervical regions which have been published. The study showed that there was a significant improvement in health related quality of life (HRQoL) after treatment, and that there were no difference in the results depending on if it was the cervical, thoracic or lumbar region that was treated. The study had ethical approval (Dnr 2012-446-31M) and is registered here at clinicaltrials.gov.

Another study explored the health economic aspects of interventional pain management (IPM). The investigators aimed to do this in comparison with pain rehabilitation programs, and therefore further ethical approval was searched and gained (2012-446-31M, 2017-542-32, 2018- 507-32) An health-economic evaluation of only IPM was performed showing that patients after treatment of diagnosed pain-focuses in zygapophyseal joint pain not only improve their HRQoL but they also reduce their medication, reduced their health-care consumption and gained in ability to work. The cost per quality adjusted life years gained was below the threshold for cost-effective health-care according to the threshold-levels defined by the national Board of Health and Welfare in Sweden. But the investigators need a larger population to select from in order to get matched controls among patients that have been through pain rehabilitation programs.

This study therefore aims to explore the national register of pain rehabilitation both in order to find matched controls and in order to make a cost-effectiveness study of pain rehabilitation program as it is performed in Sweden.

Eligibility criteria: Inclusion Criteria:

Been through pain rehabilitation program

Exclusion Criteria:

-

Primary outcomes:
measure: Health-related quality of life
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Department of Epidemiology and Global Health Umeå University
city: Vallentuna
country: Sweden
facility: Smärtkliniken Eques Indolor
Study officials:
affiliation: PhD
name: Lars Lindholm
role: STUDY_DIRECTOR
References: