FibromyalgiaNCT01172795
Diffuse Noxious Inhibitory Controls (DNIC): Nociceptive Modulation and Interaction With Neurocognitive Performance in Chronic Pain
An observational study of Fibromyalgia and Whiplash, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
Diffuse noxious inhibitory control In order to quantify central sensitization in chronic pain patients, the Diffuse Noxious Inhibitory Control (DNIC) model has been used frequently. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Whiplash, Chronic Pain
- What is being tested?
- Relaxation session and Neurocognitive test battery
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2010to Aug 2011
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Thirty patients with FM, 30 patients with WAD and 30 healthy pain-free control subjects will be enrolled. All three groups will be comparable for age, gender, education level and socioeconomic status; both patient groups will be comparable for illness duration. Sample size was calculated based on a power analysis (0.80), based on the assumption of a 20% difference of DNIC functioning after neurocognitive testing.
Who may be able to join
- 30 FM group: comply with the diagnostic criteria for FM as defined by the American College of Rheumatology.
- 30 WAD group: comply with the criteria of the Quebec Task Force (grade I to III)
- 40 healthy pain-free control subjects
- Dutch speaking
- aged between 18 and 65 years.
Who cannot join
- FM patients reporting a history of a whiplash trauma
- WAD patients fulfilling the diagnostic criteria for FM
- healthy control subjects cannot suffer any pain complaints
- cannot be pregnant or until 1 year postnatal
- asked to stop analgesics 48 hours prior to study participation, not to undertake physical exertion, and to refrain from consuming caffeine, alcohol or nicotine on the day of the experiment.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Vrije Universiteit Brussel
Brussels, Brussels Capital, 1050
Mira Meeus, PhD, 0032 485 58 21 14, mmeeus@vub.ac.be
Mira Meeus, PhD
About this study
Diffuse noxious inhibitory control In order to quantify central sensitization in chronic pain patients, the Diffuse Noxious Inhibitory Control (DNIC) model has been used frequently. DNIC relies on painful conditioning stimulation of one part of the body to inhibit pain in another part, to remove the "noise" and to focus on relevant stimuli.
Earlier studies provided evidence for malfunctioning of DNIC in Fibromyalgia (FM) patients. However, the cause of this impairment is not yet elucidated, and further study is required to unravel the pathophysiology of DNIC in FM.
Read more
Hypothalamus-Pituitary-Adrenal (HPA) axis Besides neural mechanisms, also hormonal abnormalities could cause altered pain processing. Cortisol is released in answer to pain to suppress the pain. Given the evidence for hypofunction of the hypothalamic-pituitary-adrenal axis and the lower cortisol release in response to stressors in a proportion of FM patients and in chronic whiplash associated disorders (WAD) patients, the relation between pain and cortisol in these patients may be an interesting topic to consider.
Neurocognitive performance Besides chronic pain, people with chronic WAD and FM suffer from severe concentration difficulties and decreased neurocognitive capabilities (reduced reaction time, short term memory deficits etc. The decreased neurocognitive performance is known to be related to pain severity in various chronic pain populations. It is hypothesized that malfunctioning of descending inhibitory pathways and subsequent chronic pain experience precludes optimal neurocognitive performance.
Objectives The present investigation addresses the (patho)physiological mechanisms of DNIC in chronic pain populations.
- Firstly, patients with FM, chronic WAD and healthy controls are compared regarding functioning of DNIC, cortisol levels and response and neurocognitive performance (case-control).
- Secondly, the possible interaction between the functioning of DNIC, cortisol and neurocognitive performance is studied in patients with FM, WAD and healthy control subjects (cross-sectional).
- Thirdly, to examine whether a fatiguing neurocognitive stressor changes DNIC and cortisol levels in patients with FM, chronic WAD or healthy sedentary control subjects.
- Conditions
- Fibromyalgia, Whiplash, Chronic Pain
- Being tested
- Relaxation session, Neurocognitive test battery
- Keywords
- Whiplash associated disorder, chronic pain, neural inhibition, neuropsychological tests
- Medical subject headings
- Fibromyalgia, Whiplash Injuries, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation sessionBehavioural
30 minutes relaxation session (audiotape)
Neurocognitive test batteryBehavioural
the psychomotor vigilance task, span task and the stroop task on computer
| Study group | Role | What they receive |
|---|---|---|
| healthy controls | Not described Receives: Behavioral: Relaxation session; Behavioral: Neurocognitive test battery | |
| chronic whiplash patients | Not described Receives: Behavioral: Relaxation session; Behavioral: Neurocognitive test battery | |
| Fibromyalgia patients | Not described Receives: Behavioral: Relaxation session; Behavioral: Neurocognitive test battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain inhibition efficacy
Participants are subjected to pain measurement, preceded and followed by the collection of saliva samples to analyze cortisol concentrations. Afterwards participants are randomly (by lottery) allocated to group 1 or 2. Group 1 performs a battery of neurocognitive tests and group 2 receives a relaxation session. Afterwards pain measurement with cortisol analyses is repeated.
One week later the procedure is repeated, while group 1 receives the relaxation session and group 2 performs the neurocognitive test.
Measured: immediately (5 minutes) before and after intervention (relaxation or neurocognitive test battery)
Secondary outcomes (2)
neurocognitive performance
Participants are subjected to pain measurement, preceded and followed by the collection of saliva samples to analyze cortisol concentrations. Afterwards participants are randomly (by lottery) allocated to group 1 or 2. Group 1 performs a battery of neurocognitive tests and group 2 receives a relaxation session. Afterwards pain measurement with cortisol analyses is repeated.
One week later the procedure is repeated, while group 1 receives the relaxation session and group 2 performs the neurocognitive test.
Measured: once in the study design, immediately (5 minutes) preceded and followed by the pain measurements
cortisol response to pain
Participants are subjected to pain measurement, preceded and followed by the collection of saliva samples to analyze cortisol concentrations. Afterwards participants are randomly (by lottery) allocated to group 1 or 2. Group 1 performs a battery of neurocognitive tests and group 2 receives a relaxation session. Afterwards pain measurement with cortisol analyses is repeated.
One week later the procedure is repeated, while group 1 receives the relaxation session and group 2 performs the neurocognitive test.
Measured: immediately (1 minute) before and after pain measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172795
- Sponsor's protocol ID
- B-Cognitive tests
- Status last verified
- Jul 2010
- First submitted
- 29 Jul 2010
- Last updated
- 30 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffuse Noxious Inhibitory Controls (DNIC): Nociceptive Modulation and Interaction With Neurocognitive Performance in Chronic Pain
- ClinicalTrials.gov ID
- NCT01172795
- Acronym / sponsor ID
- B-Cognitive tests
- Conditions
- Fibromyalgia, Whiplash, Chronic Pain
- Keywords
- Whiplash associated disorder, chronic pain, neural inhibition, neuropsychological tests
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 30 Jul 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.
Diffuse noxious inhibitory control In order to quantify central sensitization in chronic pain patients, the Diffuse Noxious Inhibitory Control (DNIC) model has been used frequently. DNIC relies on painful conditioning stimulation of one part of the body to inhibit pain in another part, to remove the "noise" and to focus on relevant stimuli.
Earlier studies provided evidence for malfunctioning of DNIC in Fibromyalgia (FM) patients. However, the cause of this impairment is not yet elucidated, and further study is required to unravel the pathophysiology of DNIC in FM.
Hypothalamus-Pituitary-Adrenal (HPA) axis Besides neural mechanisms, also hormonal abnormalities could cause altered pain processing. Cortisol is released in answer to pain to suppress the pain. Given the evidence for hypofunction of the hypothalamic-pituitary-adrenal axis and the lower cortisol release in response to stressors in a proportion of FM patients and in chronic whiplash associated disorders (WAD) patients, the relation between pain and cortisol in these patients may be an interesting topic to consider.
Neurocognitive performance Besides chronic pain, people with chronic WAD and FM suffer from severe concentration difficulties and decreased neurocognitive capabilities (reduced reaction time, short term memory deficits etc. The decreased neurocognitive performance is known to be related to pain severity in various chronic pain populations. It is hypothesized that malfunctioning of descending inhibitory pathways and subsequent chronic pain experience precludes optimal neurocognitive performance.
Objectives The present investigation addresses the (patho)physiological mechanisms of DNIC in chronic pain populations.
- Firstly, patients with FM, chronic WAD and healthy controls are compared regarding functioning of DNIC, cortisol levels and response and neurocognitive performance (case-control).
- Secondly, the possible interaction between the functioning of DNIC, cortisol and neurocognitive performance is studied in patients with FM, WAD and healthy control subjects (cross-sectional).
- Thirdly, to examine whether a fatiguing neurocognitive stressor changes DNIC and cortisol levels in patients with FM, chronic WAD or healthy sedentary control subjects.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy controls | – | Behavioral: Relaxation session, Behavioral: Neurocognitive test battery |
| chronic whiplash patients | – | Behavioral: Relaxation session, Behavioral: Neurocognitive test battery |
| Fibromyalgia patients | – | Behavioral: Relaxation session, Behavioral: Neurocognitive test battery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Thirty patients with FM, 30 patients with WAD and 30 healthy pain-free control subjects will be enrolled. All three groups will be comparable for age, gender, education level and socioeconomic status; both patient groups will be comparable for illness duration. Sample size was calculated based on a power analysis (0.80), based on the assumption of a 20% difference of DNIC functioning after neurocognitive testing.
Key inclusion criteria (5 listed)
- 30 FM group: comply with the diagnostic criteria for FM as defined by the American College of Rheumatology.
- 30 WAD group: comply with the criteria of the Quebec Task Force (grade I to III)
- 40 healthy pain-free control subjects
- Dutch speaking
- aged between 18 and 65 years.
Key exclusion criteria (5 listed)
- FM patients reporting a history of a whiplash trauma
- WAD patients fulfilling the diagnostic criteria for FM
- healthy control subjects cannot suffer any pain complaints
- cannot be pregnant or until 1 year postnatal
- asked to stop analgesics 48 hours prior to study participation, not to undertake physical exertion, and to refrain from consuming caffeine, alcohol or nicotine on the day of the experiment.
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 |
|---|---|---|
| Relaxation session30 minutes relaxation session (audiotape) | Behavioural | Fibromyalgia patients, chronic whiplash patients, healthy controls |
| Neurocognitive test batterythe psychomotor vigilance task, span task and the stroop task on computer | Behavioural | Fibromyalgia patients, chronic whiplash patients, healthy controls |
Primary outcome
pain inhibition efficacy
Time frame: immediately (5 minutes) before and after intervention (relaxation or neurocognitive test battery)
Participants are subjected to pain measurement, preceded and followed by the collection of saliva samples to analyze cortisol concentrations. Afterwards participants are randomly (by lottery) allocated to group 1 or 2. Group 1 performs a battery of neurocognitive tests and group 2 receives a relaxation session. Afterwards pain measurement with cortisol analyses is repeated. One week later the procedure is repeated, while group 1 receives the relaxation session and group 2 performs the neurocognitive test.
2 secondary outcomes
neurocognitive performance
Time frame: once in the study design, immediately (5 minutes) preceded and followed by the pain measurements
cortisol response to pain
Time frame: immediately (1 minute) before and after pain measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2010.
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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.
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 Fibromyalgia and Whiplash, run by Vrije Universiteit Brussel at 1 site in Belgium.
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 5 inclusion and 5 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 30 Jul 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 Belgium. 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 Mira Meeus, PhD (0032 485 58 21 14, mmeeus@vub.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain inhibition efficacy (time frame: immediately (5 minutes) before and after intervention (relaxation or neurocognitive test battery)). It is what the study was designed to measure, not a finding.
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 30 Jul 2010.