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The role of nocebo effects in identifying patients at risk for pain progression in fibromyalgia

The role of nocebo effects in identifying patients at risk for pain progression in fibromyalgia - Nocebo effects in fibromyalgia pain progression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55629
Enrollment
75
Registered
2019-08-13
Start date
2020-01-10
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgie chronic widespread pain Fibromyalgia

Interventions

None listed

Sponsors

Universiteit Leiden
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)