PainNCT00378274
Descriptive Study of Pain, Anxiety and Depression
An observational study of Pain, run by Danish Pain Research Center at 1 site in Denmark.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Observation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 75 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2006to Sep 2007
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Neuropathic pain patient or patient with fibromyalgia
- Daily pain in more than 6 months
- Weekly average pain score 4 or more (VAS)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Pain Research Center, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: 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
Read the 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
- Conditions
- Pain
- Being tested
- Observation
- Keywords
- Neuropathic pain, Chronic pain, Depression, Anxiety
- Medical subject headings
- Pain, Neuralgia, Chronic Pain, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2006 (estimated)
- Study startSep 2006
- Study completionSep 2007
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
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Pain Research Center
- Sponsor type
- University, hospital or other
- Investigators
- Lise Gormsen, MD, Principal investigator, Danish Pain Research Center, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378274
- Sponsor's protocol ID
- KVA2006LG
- Status last verified
- Nov 2007
- First submitted
- 18 Sep 2006
- Last updated
- 16 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain, Anxiety and Depression in Chronic Pain Patients With and Without Neuropathic Pain Compared With Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00378274
- Acronym / sponsor ID
- KVA2006LG
- Conditions
- Pain
- Keywords
- Neuropathic pain, Chronic pain, Depression, Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Danish Pain Research CenterUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 19 Sep 2006 (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 purpose of the study is to investigate pain, anxiety and depression in chronic pain patients with and without neuropathic pain compared with healthy volunteers
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Neuropathic pain patient or patient with fibromyalgia
- Daily pain in more than 6 months
- Weekly average pain score 4 or more (VAS)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Observation | Behavioural | – |
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 16 Nov 2007.
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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.
Lise Gormsen, MD principal investigator
Danish Pain Research Center, Aarhus University Hospital
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 Pain, run by Danish Pain Research Center 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 16 Nov 2007. 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.
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 16 Nov 2007.