Somatoform DisordersIPPPDIVNCT01106339
Immune Patterns in Pain Patients DSM-IV
An observational study of Somatoform Disorders and Fibromyalgia, run by University of Ulm at 1 site in Germany.
Trial summary
The purpose of this study is to define subgroups of patients with somatoform disorders due to DSM-IV by immunological, psychological and genetic characterization. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Somatoform Disorders, Fibromyalgia, Myofascial Pain Syndrome, Diffuse
- Type of treatment
- Injection or infusion
- How many people
- 52 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2007to Apr 2013
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: chronic pain patients with a somatoform disorder due to DSM-IV
Who may be able to join
- chronic pain patients with a somatoform disorder due to DSM-IV
- chronic pain > 6 months in several anatomical regions
- presence of physical symptoms that suggest a general medical condition
- the symptoms must cause clinically significant distress or impairment in social, occupational, or other areas of functioning
- the physical symptoms are not under voluntary control
- Psychic factors exclusively or in combination with a medical disease factor influence onset, severity, exacerbation or maintenance of symptoms decisively
- fibromyalgia
Who cannot join
- age < 18 years
- psychosis
- symptoms fully explained by a general medical condition, by the direct effects of a substance, or by another mental disorder
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of Immune, Psychometric and Sociodemographic Patterns in Pain Patients Classified by DSM-IV
The purpose of this study is to define subgroups of patients with somatoform disorders due to DSM-IV by immunological, psychological and genetic characterization.
Read the detailed description
Pain patients are defined as patients with a somatoform disorder due to DSM-IV, if chronic pain lasts for at least 6 months in several anatomical regions. Somatoform disorders (DSM-IV) have the presence of physical symptoms that suggest a general medical condition but that are not fully explained by a general medical condition, by the direct effects of a substance, or by another mental disorder. The symptoms must cause clinically significant distress or impairment in social, occupational, or other areas of functioning. The physical symptoms are not under voluntary control. Psychic factors exclusively or in combination with a medical disease factor influence onset, severity, exacerbation or maintenance of symptoms decisively. A subgroup of somatoform disorders, i.e., fibromyalgia, is a common nonarticular rheumatic syndrome characterized by myalgia and multiple points of focal muscle tenderness to palpation (trigger points). Muscle pain is typically aggravated by inactivity or exposure to cold. This condition is often associated with general symptoms, such as sleep disturbances, fatigue, stiffness, headaches, and occasionally depression. There is significant overlap between fibromyalgia and the chronic fatigue syndrome. Fibromyalgia may arise as a primary or secondary disease process. Interleukins IL-1ß, IL-6 und tumor necrosis factor-a have been detected in the skin of these patients. Blockade of the 5HT3 receptor has been reported to alleviate chronic pain in tendopathy, fibromyalgia and autoimmune diseases. However, only a subgroup of patients responds to this therapy. It is supposed that patients with somatoform disorders (DSM-IV) diagnosed according to clinical criteria consist of immunologically heterogenous groups. However, up to now, the immunologic and genetic background of patients with somatoform disorders classified via DSM-IV has not been systematically evaluated. The study concentrates on the psychometric characterization of patients with pain disorder focusing on depression, anxiety, coping behavior, psychic trauma, alexithymia and somatoform symptoms. The present study is performed to define subgroups of patients with somatoform disorders (DSM-IV) by immunological, pyschologic and genetic characterization which may benefit from potential 5HT3 receptor antagonists or anti-inflammatory therapy.
- Conditions
- Somatoform Disorders, Fibromyalgia, Myofascial Pain Syndrome, Diffuse, Depression, Chronic Fatigue Syndrome
- Keywords
- humans, patients, somatoform disorders, fibromyalgia, myofascial pain syndrome diffuse, depression, chronic fatigue syndrome, inflammation, inflammatory response, biomarkers, cytokines, cell surface markers, functional polymorphisms
- Medical subject headings
- Somatoform Disorders, Fibromyalgia, Depression, Fatigue Syndrome, Chronic, Inflammation
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 |
|---|---|---|
| A | Patients with somatoform disorders due to DSM-IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of inflammatory biomarkers
Measured: 1 year
Secondary outcomes (5)
Pattern of cell surface markers
Measured: 1 year
Functional polymorphisms
Measured: 1 year
Psychometric tests
Measured: 1 year
Demographic tests
Measured: 1 year
Severity of pain
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 posted19 Apr 2010 (estimated)
- Study startAug 2007
- Primary completionMar 2013
- Study completionApr 2013
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 Somatoform DisordersStudies 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Ulm
- Responsible party
- Principal investigator, Manfred Weiss, University of Ulm
- Investigators
- Peter Steffen, MD, Principal investigator, Clinic of Anesthesiology, University Hospital Medical School, Steinhoevelstrasse 9, 89070 Ulm, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106339
- Sponsor's protocol ID
- Anae_Pain_Ulm_DSM-IV
- Acronym
- IPPPDIV
- Status last verified
- Apr 2013
- First submitted
- 15 Apr 2010
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Schneider EM, Ma X, Stratz T, Muller W, Lorenz I, Seeling WD. Immunomodulatory function of the 5-HT3 receptor antagonist tropisetron. Scand J Rheumatol Suppl. 2004;119:34-40.
PubMed 15515411
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Immune, Psychometric and Sociodemographic Patterns in Pain Patients Classified by DSM-IV
- ClinicalTrials.gov ID
- NCT01106339
- Acronym / sponsor ID
- IPPPDIV / Anae_Pain_Ulm_DSM-IV
- Conditions
- Somatoform Disorders, Fibromyalgia, Myofascial Pain Syndrome, Diffuse, Depression, Chronic Fatigue Syndrome
- Keywords
- humans, patients, somatoform disorders, fibromyalgia, myofascial pain syndrome diffuse, depression, chronic fatigue syndrome, inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- University Hospital Ulm
- Study start
- Aug 2007
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 19 Apr 2010 (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 this study is to define subgroups of patients with somatoform disorders due to DSM-IV by immunological, psychological and genetic characterization.
Detailed description
Pain patients are defined as patients with a somatoform disorder due to DSM-IV, if chronic pain lasts for at least 6 months in several anatomical regions. Somatoform disorders (DSM-IV) have the presence of physical symptoms that suggest a general medical condition but that are not fully explained by a general medical condition, by the direct effects of a substance, or by another mental disorder. The symptoms must cause clinically significant distress or impairment in social, occupational, or other areas of functioning. The physical symptoms are not under voluntary control. Psychic factors exclusively or in combination with a medical disease factor influence onset, severity, exacerbation or maintenance of symptoms decisively. A subgroup of somatoform disorders, i.e., fibromyalgia, is a common nonarticular rheumatic syndrome characterized by myalgia and multiple points of focal muscle tenderness to palpation (trigger points). Muscle pain is typically aggravated by inactivity or exposure to cold. This condition is often associated with general symptoms, such as sleep disturbances, fatigue, stiffness, headaches, and occasionally depression. There is significant overlap between fibromyalgia and the chronic fatigue syndrome. Fibromyalgia may arise as a primary or secondary disease process. Interleukins IL-1ß, IL-6 und tumor necrosis factor-a have been detected in the skin of these patients. Blockade of the 5HT3 receptor has been reported to alleviate chronic pain in tendopathy, fibromyalgia and autoimmune diseases. However, only a subgroup of patients responds to this therapy. It is supposed that patients with somatoform disorders (DSM-IV) diagnosed according to clinical criteria consist of immunologically heterogenous groups. However, up to now, the immunologic and genetic background of patients with somatoform disorders classified via DSM-IV has not been systematically evaluated. The study concentrates on the psychometric characterization of patients with pain disorder focusing on depression, anxiety, coping behavior, psychic trauma, alexithymia and somatoform symptoms. The present study is performed to define subgroups of patients with somatoform disorders (DSM-IV) by immunological, pyschologic and genetic characterization which may benefit from potential 5HT3 receptor antagonists or anti-inflammatory therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | –Patients with somatoform disorders due to DSM-IV |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- chronic pain patients with a somatoform disorder due to DSM-IV
Key inclusion criteria (7 listed)
- chronic pain patients with a somatoform disorder due to DSM-IV
- chronic pain > 6 months in several anatomical regions
- presence of physical symptoms that suggest a general medical condition
- the symptoms must cause clinically significant distress or impairment in social, occupational, or other areas of functioning
- the physical symptoms are not under voluntary control
Key exclusion criteria (4 listed)
- age < 18 years
- psychosis
- symptoms fully explained by a general medical condition, by the direct effects of a substance, or by another mental disorder
- pregnancy
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
Pattern of inflammatory biomarkers
Time frame: 1 year
5 secondary outcomes
Pattern of cell surface markers
Time frame: 1 year
Functional polymorphisms
Time frame: 1 year
Psychometric tests
Time frame: 1 year
Demographic tests
Time frame: 1 year
Severity of pain
Time frame: 1 year
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 5 Apr 2013.
- Background: PubMed 15515411Schneider EM, Ma X, Stratz T, Muller W, Lorenz I, Seeling WD. Immunomodulatory function of the 5-HT3 receptor antagonist tropisetron. Scand J Rheumatol Suppl. 2004;119:34-40.
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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.
Peter Steffen, MD principal investigator
Clinic of Anesthesiology, University Hospital Medical School, Steinhoevelstrasse 9, 89070 Ulm, Germany
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 Somatoform Disorders and Fibromyalgia, run by University of Ulm at 1 site in Germany.
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 7 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 5 Apr 2013. 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 Germany. 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?
Pattern of inflammatory biomarkers (time frame: 1 year). 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 NCT01106339, 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 5 Apr 2013.