Chronic PainNCT01835704
Health-economic Evaulation of Interventional Pain Mangement
An observational study of Chronic Pain, run by Eques Indolor AB at 1 site in Sweden.
Trial summary
To establish the cost per QALY (Quality Adjusted life Years) gained all patients that are referred to a specialized interventional pain clinic are assessed by Euroqol EQ-5D to measure the health-related quality of life at the first visit and then during the following year. Read more about this study
- Who is it for?
- Ages 15 to 99 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Radio-frequency dennervation of facet joint and Diagnostic nerve-blocks performed under direct x-ray vision
- How many people
- 1,540 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2008to 3 Feb 2019
- 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 15 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with pain of more then 6 months duration
Who may be able to join
- All patients
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health-economic Evaluation of Interventional Pain Management Among Patients With Chronic Pain
To establish the cost per QALY (Quality Adjusted life Years) gained all patients that are referred to a specialized interventional pain clinic are assessed by Euroqol EQ-5D to measure the health-related quality of life at the first visit and then during the following year. Quality of life is calculated from EQ-5D by using hte TTO-validated UK-value set. With this and calculations of the cost we will be able to calculate the cost per QALY-gained which makes it possible to compare interventional pain managment to other treatments for pain patients.
- Conditions
- Chronic Pain
- Being tested
- Radio-frequency dennervation of facet joint, Diagnostic nerve-blocks performed under direct x-ray vision
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio-frequency dennervation of facet jointOther
Diagnostic nerve-blocks performed under direct x-ray visionOther
| Study group | Role | What they receive |
|---|---|---|
| Chronic pain associated to facet-joints | Patients where the pain can be localized to the facet joints. Receives: Other: Radio-frequency dennervation of facet joint | |
| Chronic pain of other origin | Patients with pain that can not be localized to facet joints. Receives: Other: Diagnostic nerve-blocks performed under direct x-ray vision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality Adjusted Life gained
QALY is calculated from the EQ-5D value using the TTO-validated UK value set accoring to ordinary health-economic evaluations.
Measured: 1 year
Secondary outcomes (1)
Cost per QALY gained
The cost per QALY gained is calculated according to normal health-economic evaluation models.
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 posted19 Apr 2013 (estimated)
- Study startJan 2008
- Primary completion3 Feb 2019
- Study completion3 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eques Indolor AB
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johan Hambraeus, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835704
- Sponsor's protocol ID
- SE-Dnr-2012-446-31M-2
- Status last verified
- Feb 2019
- First submitted
- 17 Apr 2013
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Hambraeus J, Pulkki-Brannstrom AM, Lindholm L. Cost-effectiveness of Radiofrequency Denervation for Zygapophyseal Joint Pain. Pain Physician. 2021 Dec;24(8):E1205-E1218.
PubMed 34793647
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-economic Evaluation of Interventional Pain Management Among Patients With Chronic Pain
- ClinicalTrials.gov ID
- NCT01835704
- Acronym / sponsor ID
- SE-Dnr-2012-446-31M-2
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,540 participants (actual)
- Lead sponsor
- Eques Indolor ABUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- 3 Feb 2019 (actual)
- Study completion
- 3 Feb 2019 (actual)
- First posted
- 19 Apr 2013 (estimated)
- 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.
To establish the cost per QALY (Quality Adjusted life Years) gained all patients that are referred to a specialized interventional pain clinic are assessed by Euroqol EQ-5D to measure the health-related quality of life at the first visit and then during the following year. Quality of life is calculated from EQ-5D by using hte TTO-validated UK-value set. With this and calculations of the cost we will be able to calculate the cost per QALY-gained which makes it possible to compare interventional pain managment to other treatments for pain patients.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic pain associated to facet-joints | – | Other: Radio-frequency dennervation of facet jointPatients where the pain can be localized to the facet joints. |
| Chronic pain of other origin | – | Other: Diagnostic nerve-blocks performed under direct x-ray visionPatients with pain that can not be localized to facet joints. |
Who may qualify
- Ages
- 15 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pain of more then 6 months duration
Key inclusion criteria (1 listed)
- All patients
Key exclusion criteria (0 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 |
|---|---|---|
| Radio-frequency dennervation of facet joint | Other | Chronic pain associated to facet-joints |
| Diagnostic nerve-blocks performed under direct x-ray vision | Other | Chronic pain of other origin |
Primary outcome
Quality Adjusted Life gained
Time frame: 1 year
QALY is calculated from the EQ-5D value using the TTO-validated UK value set accoring to ordinary health-economic evaluations.
1 secondary outcome
Cost per QALY gained
Time frame: 1 year
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 19 Feb 2019.
- Derived from this study: PubMed 34793647Hambraeus J, Pulkki-Brannstrom AM, Lindholm L. Cost-effectiveness of Radiofrequency Denervation for Zygapophyseal Joint Pain. Pain Physician. 2021 Dec;24(8):E1205-E1218.
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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.
Johan Hambraeus, MD principal investigator
1 site 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 1 site 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 0 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 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Quality Adjusted Life gained (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01835704, which also lists 1 linked publication.
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 19 Feb 2019.