The primary objective of this study is to examine whether distraction interferes with CPM modulation differently in patients with fibromyalgia compared to healthy controls. Secondary objectives include assessing whether patients have a general…
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Brief title
Condition
- Musculoskeletal and connective tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the effect of attentional modulation on CPM
efficacy in patients with fibromyalgia compared to healthy controls.
Secondary outcome
Secondary parameters are: 1) attentional task performance in patients with
fibromyalgia versus healthy controls, 2) associations between CPM efficacy and
cognitive inhibition, and 3) sex differences in CPM efficacy and attentional
effects in fibromylagia versus healthy controls.
Background summary
Conditioned pain modulation (CPM), the phenomenon that pain inhibits pain,
reflects a central pain modulatory system that relies on spinal and supraspinal
mechanisms. Previous studies have shown that fibromyalgia patients have
deficits in CPM compared to healthy controls. It has been argued that the CPM
effect can be partly explained by attentional manipulation as application of a
second painful stimulus may distract attention from the first painful stimulus.
It remains however unclear what role attention plays in endogenous modulation
of pain, specifically in fibromyalgia.
Study objective
The primary objective of this study is to examine whether distraction
interferes with CPM modulation differently in patients with fibromyalgia
compared to healthy controls. Secondary objectives include assessing whether
patients have a general deficit in executive attentional function, if CPM
magnitude is related to cognitive inhibition, and how sex differences may
explain CPM magnitude differences in fibromyalgia patients compared to healthy
controls.
Study design
This study is a monocenter randomized repeated measures study. Subjects will be
screened for study participation and informed consent will be signed.
Procedures will be explained and questionnaires will be filled out. Subjects
will not be informed about the actual study hypotheses or on the pain intensity
levels applied beforehand to avoid expectancy influencing the data. This is a
common procedure in this type of research. Painful stimulation levels will be
individually determined and attentional tasks including the attention network
test and the Stroop color-word test will be performed. Also, a memory task and
a tapping task will be performed. Four experimental sessions will be completed
semi-randomly: 1) painful test stimulus alone, 2) test stimulus in combination
with a conditioning stimulus (CPM), 3) test stimulus in combination with a
Stroop distraction task, 4) CPM in combination with a Stroop distraction task.
Difference scores in pain ratings of test stimuli alone or in combination with
another stimulus will be determined. As a control, painful stimulation will be
repeated after experimental testing to verify that no shifts in baseline
measures occurred and subjects will be debriefed.
Study burden and risks
Participants will complete one visit of approximately 2 hours at the Pain
Clinic of the UMC Utrecht. Risks associated with study participation are
minimal. The equipment used to induce pain is safe and commonly used in
clinical practice. There will be no direct benefit to participants. The present
study will provide new insights in the mechanisms of endogenous pain modulation
and will demonstrate what role attention plays in CPM efficacy. Participants
will be able to terminate study participation at any time, for any reason.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
Patients will have the diagnosis of primary fibromyalgia according to the American College of Rheumatology (ACR) classification criteria. Control participants will be matched on age and educational level to fibromyalgia patients and will be healthy and pain-free as determined by a general health questionnaire, and not take any psychoactive medication or analgesics. All subjects will be adults over the age of 18 years old and speak Dutch fluently.
Exclusion criteria
The inability to give informed consent, a serious neurological or psychiatric condition besides fibromyalgia, current participation in another research protocol that could interfere or influence the outcome measures of the present study , current use of sedative psychotropic or analgesic drugs (e.g., benzodiazepine, antiepileptics, barbiturates and opioids) except amitriptyline in low dosages (<50 mg/day), or when there is any serious injury to the body regions to be tested as reported by the research participant.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36078.041.11 |