NCT04657159

Brief Summary

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

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,611

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

February 16, 2023

Status Verified

July 1, 2022

Enrollment Period

1.1 years

First QC Date

December 1, 2020

Last Update Submit

February 14, 2023

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • Health-related quality of life

    EQ-5D index

    1 year

Study Arms (2)

2010-2016

Patients treated 2010-2016

Other: Pain rehabilitation program

2017-2019

Patients treated 2017-2019

Other: Pain rehabilitation program

Interventions

Pain rehabilitation programOTHER

Effect on health related quality of life och health-care consumption after rehabilitation

2010-20162017-2019

Eligibility Criteria

Age18 Years - 94 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Been through pain rehabilitation program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Epidemiology and Global Health Umeå University

Umeå, 90185, Sweden

Location

Smärtkliniken Eques Indolor

Vallentuna, 18695, Sweden

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lars Lindholm

    PhD

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2020

First Posted

December 8, 2020

Study Start

December 1, 2020

Primary Completion

December 30, 2021

Study Completion

September 30, 2022

Last Updated

February 16, 2023

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Sharing IPD is restricted by law in Sweden and any sharing needs a specific approval from ethics board

Locations

SE(2)