Health-economic Evaluation of Interventional Pain Management Compared to Pain Rehabilitation

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Pain rehabilitation program

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.

• Study Type: Observational
• Enrollment (Actual): 15611

Contacts and Locations

Study Locations

• Sweden
  • Umeå, Sweden, 90185
    • Department of Epidemiology and Global Health Umeå University
  • Vallentuna, Sweden, 18695
    • Smärtkliniken Eques Indolor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 94 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

Been through pain rehabilitation program

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
2010-2016; Patients treated 2010-2016	Other: Pain rehabilitation program; Effect on health related quality of life och health-care consumption after rehabilitation
2017-2019; Patients treated 2017-2019	Other: Pain rehabilitation program; Effect on health related quality of life och health-care consumption after rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life	EQ-5D index	1 year

Collaborators and Investigators

• Sponsor: Eques Indolor AB
• Collaborators: Umeå University
• Investigators: Study Director: Lars Lindholm, PhD

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (Actual): December 8, 2020

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: IPM-PRP2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sharing IPD is restricted by law in Sweden and any sharing needs a specific approval from ethics board

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No