Chronic PainNCT04657159
Health-economic Evaluation of Interventional Pain Management Compared to Pain Rehabilitation
An observational study of Chronic Pain, run by Eques Indolor AB at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 94 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Pain rehabilitation program
- How many people
- 15,611 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Dec 2020to 30 Sep 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 94 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Been through pain rehabilitation program
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Department of Epidemiology and Global Health Umeå University
Umeå, 90185
Smärtkliniken Eques Indolor
Vallentuna, 18695
About this study
The overall aim of the study is to evaluate interventional pain management. This is done in three steps:
- To find matched controls to the patients in the study on cost-effectiveness of IPM and compare the results.
- To calculate cost-effectiveness of PRP during the period 2010-2016, on a national level.
- 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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Pain rehabilitation program
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain rehabilitation programOther
Effect on health related quality of life och health-care consumption after rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| 2010-2016 | Patients treated 2010-2016 Receives: Other: Pain rehabilitation program | |
| 2017-2019 | Patients treated 2017-2019 Receives: Other: Pain rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life
EQ-5D index
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Dec 2020
- Primary completion30 Dec 2021
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,611 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Eques Indolor AB
- Sponsor type
- University, hospital or other
- Collaborators
- Umeå University
- Responsible party
- Sponsor
- Investigators
- Lars Lindholm, Study director, PhD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657159
- Sponsor's protocol ID
- IPM-PRP2020
- Status last verified
- Jul 2022
- First submitted
- 1 Dec 2020
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing IPD is restricted by law in Sweden and any sharing needs a specific approval from ethics board
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-economic Evaluation of Interventional Pain Management Compared to Pain Rehabilitation
- ClinicalTrials.gov ID
- NCT04657159
- Acronym / sponsor ID
- IPM-PRP2020
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,611 participants (actual)
- Lead sponsor
- Eques Indolor ABUniversity, hospital or other
- Collaborators
- Umeå University
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of the study is to evaluate interventional pain management. This is done in three steps:
- To find matched controls to the patients in the study on cost-effectiveness of IPM and compare the results.
- To calculate cost-effectiveness of PRP during the period 2010-2016, on a national level.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2010-2016 | – | Other: Pain rehabilitation programPatients treated 2010-2016 |
| 2017-2019 | – | Other: Pain rehabilitation programPatients treated 2017-2019 |
Who may qualify
- Ages
- 18 to 94 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Been through pain rehabilitation program
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain rehabilitation programEffect on health related quality of life och health-care consumption after rehabilitation | Other | 2010-2016, 2017-2019 |
Primary outcome
Health-related quality of life
Time frame: 1 year
EQ-5D index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: No. Sharing IPD is restricted by law in Sweden and any sharing needs a specific approval from ethics board
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Lindholm study director
PhD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Eques Indolor AB at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.