PainNCT00957645
Central Post-Stroke Pain - a Prospective Study
An observational study of Pain, run by Danish Pain Research Center.
Trial summary
Part 1: The purpose of the first part of the study is to investigate the prevalence of pain at stroke onset and 3 and 6 months after stroke in a consecutive cohort of stroke patients admitted to a stroke unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- How many people
- 275 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Jul 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive stroke patients admitted to the Stroke Unit of the Department of Neurology at Aarhus University Hospital between February 2008 to October 2009
Who may be able to join
- Recent cerebrovascular stroke
Who cannot join
- Severe dementia, aphasia or psychosis
- Patients who cannot cooperate at time of inclusion
- Patients who do not understand Danish
About this study
Official title: Central Post-Stroke Pain - a Prospective Study of Consecutively Admitted Patients With Recent Stroke
Part 1: The purpose of the first part of the study is to investigate the prevalence of pain at stroke onset and 3 and 6 months after stroke in a consecutive cohort of stroke patients admitted to a stroke unit.
Part 2: The purpose of the second part of the study is to identify patients who develop central post-stroke pain within the first 6 months following stroke and to try to identify early prognostic factors for the development of pain.
Read the detailed description
Part 1:
- Within 3 days of admission: medical history, pain history, sensory examination
- Telephone follow-up at 3 and 6 months post-stroke: pain history
Part 2:
- Medical history, Pain history, Sensory examination
- Conditions
- Pain
- Keywords
- Central post-stroke pain, post-stroke pain, shoulder pain
- Medical subject headings
- Pain, Shoulder Pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startFeb 2008
- Primary completionMay 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Pain Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henriette Klit, MD, Principal investigator, Danish Pain Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957645
- Sponsor's protocol ID
- 20060116
- Status last verified
- Aug 2011
- First submitted
- 11 Aug 2009
- Last updated
- 30 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Post-Stroke Pain - a Prospective Study of Consecutively Admitted Patients With Recent Stroke
- ClinicalTrials.gov ID
- NCT00957645
- Acronym / sponsor ID
- 20060116
- Conditions
- Pain
- Keywords
- Central post-stroke pain, post-stroke pain, shoulder pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Danish Pain Research CenterUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 12 Aug 2009 (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.
Part 1: The purpose of the first part of the study is to investigate the prevalence of pain at stroke onset and 3 and 6 months after stroke in a consecutive cohort of stroke patients admitted to a stroke unit.
Part 2: The purpose of the second part of the study is to identify patients who develop central post-stroke pain within the first 6 months following stroke and to try to identify early prognostic factors for the development of pain.
Detailed description
Part 1:
- Within 3 days of admission: medical history, pain history, sensory examination
- Telephone follow-up at 3 and 6 months post-stroke: pain history
Part 2:
- Medical history, Pain history, Sensory examination
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive stroke patients admitted to the Stroke Unit of the Department of Neurology at Aarhus University Hospital between February 2008 to October 2009
Key inclusion criteria (1 listed)
- Recent cerebrovascular stroke
Key exclusion criteria (3 listed)
- Severe dementia, aphasia or psychosis
- Patients who cannot cooperate at time of inclusion
- Patients who do not understand Danish
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
Not reported in the source record.
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 30 Aug 2011.
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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.
Henriette Klit, MD principal investigator
Danish Pain Research Center
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Danish Pain Research Center.
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 3 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 30 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
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 30 Aug 2011.