- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00378274
Descriptive Study of Pain, Anxiety and Depression
November 15, 2007 updated by: Danish Pain Research Center
Pain, Anxiety and Depression in Chronic Pain Patients With and Without Neuropathic Pain Compared With Healthy Volunteers
The purpose of the study is to investigate pain, anxiety and depression in chronic pain patients with and without neuropathic pain compared with healthy volunteers
Study Overview
Detailed Description
Primary outcome measures:
- Symptom checklist 92
Secondary outcome measures:
- Hamilton Depression and Anxiety Rating Scale
- Major Depression Inventory
- GAD-10 Anxiety Scale
- Health Survey SF-36
- McGill Pain Questionnaire
- Sweat test
- Heart rate variability testing
- Coping Strategy Questionnare
- Quantitative sensory testing
- Pain Catastrophizing Scale
- Pain rating (VAS)
- Interview
Study Type
Observational
Enrollment (Anticipated)
75
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aarhus, Denmark, 8000
- Danish Pain Research Center, Aarhus University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Neuropathic pain patient or patient with fibromyalgia
- Daily pain in more than 6 months
- Weekly average pain score 4 or more (VAS)
Exclusion Criteria:
- Treatment with antidepressants, anticonvulsants or any other pain medication except paracetamol
- Serious or unstable medical disease
- Prior or present diagnosis of mania, bipolar or psychotic disorder, delirium, suicidal, drug and alcohol dependence, severe agitation
- Patients who cannot cooperate and do not understand Danish
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lise Gormsen, MD, Danish Pain Research Center, Aarhus University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
September 18, 2006
First Submitted That Met QC Criteria
September 18, 2006
First Posted (Estimate)
September 19, 2006
Study Record Updates
Last Update Posted (Estimate)
November 16, 2007
Last Update Submitted That Met QC Criteria
November 15, 2007
Last Verified
November 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KVA2006LG
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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