The main aim of this study is to investigate directed forgetting of emotional versus neutral words in patients with fibromyalgia compared to healthy controls. Secondary objectives are to examine potential associations between directed forgetting and…
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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 directed forgetting effect (less number of
items recalled after the *forget* cue compared to those after the *remember*
cue) for the neutral, positive, negative and pain-related words separately in
patients with fibromyalgia compared to healthy controls.
Secondary outcome
Secondary parameters are associations between directed forgetting and: 1) CPM
efficacy, and 2) numerical ratings of arousal, valence or personal-relevance of
each word.
Background summary
Directed forgetting reflects the capacity to intentionally forget irrelevant
material but at the same time to remember relevant material. Intentional
forgetting has been shown to depend on active inhibition mediated by frontal
cortical areas. Deficits in directed forgetting have been found in a number of
psychiatric disorders associated with reduced frontally-mediated inhibitory
function. Moreover, reduced inhibitory capacity may be particularly reflected
in processing emotional negative material relevant to the disease. No studies
have assessed performance on the directed forgetting task in patients with
fibromyalgia before. It is to be expected that patients with fibromyalgia will
have poor directed forgetting as well since frontal inhibitory functions seem
to be deficient in this syndrome. Furthermore, it is hypothesized that patients
with fibromyalgia will have a bias to remember negative rather than positive or
neutral information, which will be most pronounced for pain-related material.
This focus on negative information may interfere with daily activities.
Study objective
The main aim of this study is to investigate directed forgetting of emotional
versus neutral words in patients with fibromyalgia compared to healthy
controls. Secondary objectives are to examine potential associations between
directed forgetting and 1) efficiency of pain control as examined by
conditioned pain modulation (CPM), and 2) ratings of arousal, valence, and
personal-relatedness of the words to determine which aspect mediates the
directed forgetting effect most.
Study design
This is a monocenter observational case-control study. Participants will be
screened for study participation and informed consent will be signed. The
experiment involves 9 phases: 1) welcome and filling out baseline
questionnaires, 2) pain testing, 3) filling out some questionnaires, 4)
encoding phase of the directed forgetting task in which all participants are
presented with 12 neutral, 12 positive, 12 negative, and 12 pain-related words
and are given instructions to remember or forget each word after it is
presented, 5) complete a Dutch reading test as a distraction test, 6) free
recall of words, 7) a recognition test comprised of 96 words (48 old and 48 new
words), 8) numerical ratings of the 48 experimental words, and 9) filling out
remaining questionnaires.
Study burden and risks
Participants will complete one visit of approximately 1* 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. This study will test for the first time whether patients
with fibromyalgia have a dysfunction in the ability to forget disturbing
information and whether this is associated with endogenous pain modulation.
There will be no direct benefit to participants. Participants will be able to
terminate study participation at any time, for any reason.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Fibromyalgia patients will have a diagnosis of primary fibromyalgia according to the American College of Rheumatology classification criteria (Wolfe et al., 1990).
Control participants will be age-matched to fibromyalgia patients and will be healthy and pain-free as determined by a general health questionnaire.
All subjects will be adults 18 years or older
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 drugs such as benzodiazepines, barbiturates, tricyclic antidepressants, anticonvulsants, sedatives and classical antihistaminics, except amitriptyline in low dosages (up to 50 mg/day).
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 | NL40119.041.12 |