Chronic PainNCT01836666
Effects on Health Related Quality of Life Among Patients With Chronic Pain by Interventional Pain Management
An observational study of Chronic Pain, run by Eques Indolor AB at 1 site in Sweden.
Trial summary
How are the health related quality of life among patients with chronic pain effected by interventional pain managment? Hypothesis: Health related quality of life can be improved by interventional pain management both among patients with localizable pain focuses and among patients among whom no pain focuses can be… Read more about this study
- Who is it for?
- Ages 15 to 99 years
- Conditions the study is for
- Chronic Pain
- How many people
- 873 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2008to 31 Dec 2017
- How long will I take part?
- 1 Year
- 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 referred to a specialized interventional pain management clinic in northen sweden
Who may be able to join
- All patients
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
How are the health related quality of life among patients with chronic pain effected by interventional pain managment?
Hypothesis:
Health related quality of life can be improved by interventional pain management both among patients with localizable pain focuses and among patients among whom no pain focuses can be found.
Method:
Health related quality of life using EQ-5D and EQ-VAS is registered at first visit, at the time of treatment for pain focuses an during the following 12 months.
- Conditions
- Chronic Pain
- Medical subject headings
- Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ-VAS
EQ-VAS is measured at first visit, at time for treatment and 3, 6 and 12 months after treatment. EQ-VAS gives a value of quality of life, and mainly used to verify the results achieved from EQ-5D since it is not possible to calculate QALY from EQ-VAS
Measured: 1 year
EQ-5D
EQ-5D is assessed at first visit, at time for treatment and 3, 6 and 12 months after treatment. Quality of life is calculated from EQ-5D using the TTO-valuated UK value sets. This value can also be used for calculation of QALY, Quality adjusted life years.
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 posted22 Apr 2013 (estimated)
- Study startJan 2008
- Primary completionDec 2017
- Study completion31 Dec 2017
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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 873 participants (actual)
- Target duration
- 1 Year
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
- NCT01836666
- Sponsor's protocol ID
- SE-Dnr-2012-446-31M-1
- Status last verified
- Feb 2019
- First submitted
- 16 Apr 2013
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
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
- Effects on Health Related Quality of Life Among Patients With Chronic Pain by Interventional Pain Management
- ClinicalTrials.gov ID
- NCT01836666
- Acronym / sponsor ID
- SE-Dnr-2012-446-31M-1
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 873 participants (actual)
- Lead sponsor
- Eques Indolor ABUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 22 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.
How are the health related quality of life among patients with chronic pain effected by interventional pain managment?
Hypothesis:
Health related quality of life can be improved by interventional pain management both among patients with localizable pain focuses and among patients among whom no pain focuses can be found.
Method:
Health related quality of life using EQ-5D and EQ-VAS is registered at first visit, at the time of treatment for pain focuses an during the following 12 months.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 15 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients referred to a specialized interventional pain management clinic in northen sweden
Key inclusion criteria (1 listed)
- All patients
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.
Primary outcome
EQ-VAS
Time frame: 1 year
EQ-VAS is measured at first visit, at time for treatment and 3, 6 and 12 months after treatment. EQ-VAS gives a value of quality of life, and mainly used to verify the results achieved from EQ-5D since it is not possible to calculate QALY from EQ-VAS
EQ-5D
Time frame: 1 year
EQ-5D is assessed at first visit, at time for treatment and 3, 6 and 12 months after treatment. Quality of life is calculated from EQ-5D using the TTO-valuated UK value sets. This value can also be used for calculation of QALY, Quality adjusted life years.
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.
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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 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 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?
EQ-VAS (time frame: 1 year). The study lists 2 primary outcomes in all. 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 19 Feb 2019.