FibromyalgiaNCT00222209
Clinical Study on Implicit Learning, Comorbidity and Stress Vulnerability in Chronic Functional Pain
A study testing Experimental heat pain model in people with Fibromyalgia and Irritable Bowel Syndrome, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
The project investigates on the role of pain avoidance, comorbidity and stress response for the development of chronic somatic and visceral pain. We, the researchers at University Hospital Mannheim, assume that implicit operant learning of pain sensitization is a central mechanism of the process of pain becoming… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Irritable Bowel Syndrome
- What is being tested?
- Experimental heat pain model
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2005to Nov 2007
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fibromyalgia according to American College of Rheumatology (ACR) criteria
- Visceral hypersensitivity according to ROME criteria
- Chronic pain according to International Association for the Study of Pain (IASP) criteria
Who cannot join
- Abnormal quantitative sensory testing
- Psychiatric or neurological anamnesis, except fear and depression
- Acute major depression
- Substance abuse
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Mannheim - Otto-Selz-Institute
Mannheim, D-68131
Dieter Kleinboehl, Dr. phil., +49 621 181 2111, kleinboehl@osi.uni-mannheim.de
About this study
Official title: Implicit Learning, Comorbidity and Stress Vulnerability in Chronic Functional Pain Syndromes
The project investigates on the role of pain avoidance, comorbidity and stress response for the development of chronic somatic and visceral pain. We, the researchers at University Hospital Mannheim, assume that implicit operant learning of pain sensitization is a central mechanism of the process of pain becoming chronic, which is augmented by fear and by avoidance behaviour. Somatic and psychological comorbidity as well as stress factors are further promoting factors in chronic pain development.
Read the detailed description
Study 1: Implicit operant learning of sensitization and habituation in an experimental heat pain model will be investigated and compared in healthy controls, chronic pain patients with fibromyalgia, with and w/o visceral pain.
Study 2: Functional imaging of implicit operant learning of sensitization and habituation in an experimental heat pain model (same subgroups as in study 1).
- Conditions
- Fibromyalgia, Irritable Bowel Syndrome
- Being tested
- Experimental heat pain model
- Keywords
- Experimental study, chronic pain, operant learning, comorbidity, stress, Fibromyalgia w visceral hypersensitivity, Fibromyalgia w/o visceral hypersensitivity
- Medical subject headings
- Fibromyalgia, Irritable Bowel Syndrome, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental heat pain modelBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2005
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 64 participants
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Investigators
- Rupert Hoelzl, Prof. Dr. phil., Study director, University of MannheimHans-Joachim Bender, Prof. Dr. med. rer. nat., Study director, Universitätsmedizin MannheimLothar-Rudi Schad, Prof. Dr. rer. nat., Study director, German Cancer Research Centre Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222209
- Sponsor's protocol ID
- DFG HO 904/11-3,4
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 3 Aug 2006
- Results posted
- No
Publications
Holzl R, Kleinbohl D, Huse E. Implicit operant learning of pain sensitization. Pain. 2005 May;115(1-2):12-20. doi: 10.1016/j.pain.2005.01.026.
PubMed 15836965Kleinbohl D, Holzl R, Moltner A, Rommel C, Weber C, Osswald PM. Psychophysical measures of sensitization to tonic heat discriminate chronic pain patients. Pain. 1999 May;81(1-2):35-43. doi: 10.1016/s0304-3959(98)00266-8.
PubMed 10353491
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implicit Learning, Comorbidity and Stress Vulnerability in Chronic Functional Pain Syndromes
- ClinicalTrials.gov ID
- NCT00222209
- Acronym / sponsor ID
- DFG HO 904/11-3,4
- Conditions
- Fibromyalgia, Irritable Bowel Syndrome
- Keywords
- Experimental study, chronic pain, operant learning, comorbidity, stress, Fibromyalgia w visceral hypersensitivity, Fibromyalgia w/o visceral hypersensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Sep 2005
- Study completion
- Nov 2007
- First posted
- 22 Sep 2005 (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 project investigates on the role of pain avoidance, comorbidity and stress response for the development of chronic somatic and visceral pain. We, the researchers at University Hospital Mannheim, assume that implicit operant learning of pain sensitization is a central mechanism of the process of pain becoming chronic, which is augmented by fear and by avoidance behaviour. Somatic and psychological comorbidity as well as stress factors are further promoting factors in chronic pain development.
Detailed description
Study 1: Implicit operant learning of sensitization and habituation in an experimental heat pain model will be investigated and compared in healthy controls, chronic pain patients with fibromyalgia, with and w/o visceral pain.
Study 2: Functional imaging of implicit operant learning of sensitization and habituation in an experimental heat pain model (same subgroups as in study 1).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fibromyalgia according to American College of Rheumatology (ACR) criteria
- Visceral hypersensitivity according to ROME criteria
- Chronic pain according to International Association for the Study of Pain (IASP) criteria
Key exclusion criteria (4 listed)
- Abnormal quantitative sensory testing
- Psychiatric or neurological anamnesis, except fear and depression
- Acute major depression
- Substance abuse
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 |
|---|---|---|
| Experimental heat pain model | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2006.
- Background: PubMed 15836965Holzl R, Kleinbohl D, Huse E. Implicit operant learning of pain sensitization. Pain. 2005 May;115(1-2):12-20. doi: 10.1016/j.pain.2005.01.026.
- Background: PubMed 10353491Kleinbohl D, Holzl R, Moltner A, Rommel C, Weber C, Osswald PM. Psychophysical measures of sensitization to tonic heat discriminate chronic pain patients. Pain. 1999 May;81(1-2):35-43. doi: 10.1016/s0304-3959(98)00266-8.
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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.
Rupert Hoelzl, Prof. Dr. phil. study director
University of Mannheim
Hans-Joachim Bender, Prof. Dr. med. rer. nat. study director
Universitätsmedizin Mannheim
Lothar-Rudi Schad, Prof. Dr. rer. nat. study director
German Cancer Research Centre Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental heat pain model in people with Fibromyalgia and Irritable Bowel Syndrome, run by Universitätsmedizin Mannheim 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 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: status not confirmed, as of the sponsor's last update on 3 Aug 2006. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulrike Kiessling, Dr. phil. (+49 621 181 3406, hornberger@osi.uni-mannheim.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00222209, which also lists 2 linked publications.
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 3 Aug 2006.