This research project examines whether: -susceptibility to nocebo effects predicts future pain progression in patients with chronic widespread pain, i.e. fibromyalgia (part 1), - nocebo-related learning processes differ between patients and healthy…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Fibromyalgie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In part 1, individual susceptibility to nocebo conditioning (pain levels in
conditioned trials versus control trials) will be studied as predictor of the
main follow-up parameter, i.e., changes in self-reported clinical pain from
baseline to follow-up. In part 2, susceptibility to nocebo conditioning will be
examined and compared between patients and healthy controls. In part 3,
within-group stability in susceptibility to nocebo conditioning will be
examined across 1 month.
Secondary outcome
Secondary study parameter of part 1 include individual differences in
susceptibility to extinction learning as secondary predictor of pain
progression. We will also explore the relation of these predictors, i.e. nocebo
conditioning and extinction, to secondary follow-up parameters of fibromyalgia
progression and daily symptom fluctuations. In part 2, extinction learning will
be examined and compared between patients and healthy controls, and in part 3
within-group stability in extinction learning, and between-group comparisons of
stability in nocebo-related learning processes (conditioning and extinction)
will be examined across 1 month.
Background summary
Somatic symptoms often become chronic or progress due to sensitization
processes. Nocebo effects, i.e. adverse treatment outcomes not attributable to
active treatment components, could play a role in symptom progression.
Study objective
This research project examines whether: -susceptibility to nocebo effects
predicts future pain progression in patients with chronic widespread pain, i.e.
fibromyalgia (part 1), - nocebo-related learning processes differ between
patients and healthy controls (part 2), and - nocebo-related learning processes
are stable over time (part 3).
Study design
The current proposal consists of three interrelated studies with overlapping
procedures. Part 1 is a prospective predictive study, in which individual
susceptibility to nocebo conditioning with pressure pain stimuli in the
laboratory is examined as predictor of pain progression in patients with
fibromyalgia. Pain progression will be assessed after one year by
questionnaires and experience sampling method (ESM; 21 days). For part 2, the
nocebo-related learning processes (conditioning and extinction) of a subgroup
of patients will be examined and compared to that of matched healthy controls
at baseline. For part 3, in the same subgroups as for part 2, the stability of
nocebo-related learning processes between baseline and 1-month follow-up
measures will be examined.
Intervention
not applicable
Study burden and risks
Multiple studies on patients with fibromyalgia have used pressure pain stimuli
and no risks are associated with applying pressure to the thumbnail.
Administering pressure to the thumbnail can lead to possible discomfort (e.g.,
slight numbness, discoloration), however, this is temporary and dissapears on
its own. Pressure intensities will be calibrated to individual pain
sensitivity levels. Since we will use a nocebo conditioning procedure, patients
will experience possible increases of pain in the laboratory session; however,
with the combination of extinction procedure and a recovery period, including
e.g., a relaxation task, following immediately, this pain increase will be
short-lived. In total,103 patients and 34 healthy controls, matched to a
subgroup of 34 patients, will complete one laboratory session of approximately
2,5 hours and 2 hours, respectively. The same subgroup of 34 patients and 34
matched healthy controls will participate in a second laboratory session of 2
hours, one month after the first. All participants will fill out online
questionnaires and only patients will fill out ESM diary measures at baseline
and one-year follow-up with only the burden of time.
Wassenaarseweg 52
Leiden 2333 AK
NL
Wassenaarseweg 52
Leiden 2333 AK
NL
Listed location countries
Age
Inclusion criteria
18-65 years old female
Good understanding of written and spoken Dutch
Additionally for Patients:
Diagnosis of fibromyalgia (provided by a rheumatologist)
Exclusion criteria
For patients:
Physical conditions other than fibromyalgia explaining pain symptoms
Psychiatric conditions not related to fibromyalgia symptoms (e.g.,
schizophrenia)
Use of painkillers different than usual dose of treatment on the day of
experimentation*
For healthy controls:
Chronic pain complaints (>=3 months) in the past or present or a diagnosis of
fibromyalgia
Severe physical or psychiatric co-morbidities that may interfere with the study
protocol (e.g., DSM-V diagnosis)
Current pain (>=3/10 on the Numeric Rating Scale) on the day of experimentation*
Use of painkillers within 24 hours before the day of experimentation*
Common criteria for both groups:
Pregnancy or lactation
Color blindness
Injuries/open wounds on the non-dominant hand or arm*
Carrying a pacemaker/implanted pumps
Having implanted metals on the non-dominant hand or arm
Refusal to remove artificial nails, nail polish, or any other substance
covering the thumbnail*
Unsuccessful pressure calibration, i.e., not being able to stably distinguish
relevant pressure intensities
*Exclusion criteria marked with a * pertain to the day of testing. In case one
or more of these criteria are met at the day of testing, the appointment will
be rescheduled if possible.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL67541.058.18 |