Neuropathic PainNCT00910949
Sensory Perception After Thoracotomy
An observational study of Neuropathic Pain and Thoracotomy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The study will investigate characteristics of chronic pain after thoracotomy Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Neuropathic Pain, Thoracotomy, Chronic Pain
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2009to Jan 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung cancer patients
Who may be able to join
- Able to understand and give consent
- Can read
- Residing in Denmark
Who cannot join
- Unable to understand the written information in Danish
- Abuse (Medicine, Drugs, Alcohol)
- Severe psychiatric Illness
- Conflicting neurological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Pain After Thoracotomy
The study will investigate characteristics of chronic pain after thoracotomy
- Conditions
- Neuropathic Pain, Thoracotomy, Chronic Pain
- Keywords
- persistent pain, neuropathic pain, Thoracotomy, Chronic Pain
- Medical subject headings
- Neuralgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Painfree | Thoracotomy patients without chronic pain | |
| With Pain | Thoracotomy patients with chronic pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
QST score
Measured: 1 y
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJan 2010
- Study completionJan 2010
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 Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910949
- Sponsor's protocol ID
- H-B-2008-059b
- Status last verified
- Jan 2010
- First submitted
- 28 May 2009
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Wildgaard K, Ravn J, Kehlet H. Chronic post-thoracotomy pain: a critical review of pathogenic mechanisms and strategies for prevention. Eur J Cardiothorac Surg. 2009 Jul;36(1):170-80. doi: 10.1016/j.ejcts.2009.02.005.
PubMed 19307137
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain After Thoracotomy
- ClinicalTrials.gov ID
- NCT00910949
- Acronym / sponsor ID
- H-B-2008-059b
- Conditions
- Neuropathic Pain, Thoracotomy, Chronic Pain
- Keywords
- persistent pain, neuropathic pain, Thoracotomy, Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 1 Jun 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.
The study will investigate characteristics of chronic pain after thoracotomy
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Painfree | – | –Thoracotomy patients without chronic pain |
| With Pain | – | –Thoracotomy patients with chronic pain |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients
Key inclusion criteria (3 listed)
- Able to understand and give consent
- Can read
- Residing in Denmark
Key exclusion criteria (4 listed)
- Unable to understand the written information in Danish
- Abuse (Medicine, Drugs, Alcohol)
- Severe psychiatric Illness
- Conflicting neurological disease
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
QST score
Time frame: 1 y
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 2 Feb 2010.
- Background: PubMed 19307137Wildgaard K, Ravn J, Kehlet H. Chronic post-thoracotomy pain: a critical review of pathogenic mechanisms and strategies for prevention. Eur J Cardiothorac Surg. 2009 Jul;36(1):170-80. doi: 10.1016/j.ejcts.2009.02.005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neuropathic Pain and Thoracotomy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 inclusion and 4 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 2 Feb 2010. 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 Denmark. 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?
QST score (time frame: 1 y). 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 NCT00910949, 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 2 Feb 2010.