Understanding body awareness in fibromyalgia patients
Proprioception and Interoception in Patients With Fibromyalgia
This study is trying to see how fibromyalgia affects the way patients feel their body and its position compared to healthy people.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hasselt University Academic / other |
| Locations | 2 sites (Diepenbeek, Limburg and 1 other locations) |
| Trial ID | NCT05907590 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the differences in interoception and proprioception between patients with fibromyalgia and healthy controls. Participants will engage in various tasks, including respiratory occlusion discrimination and postural control assessments, while also completing questionnaires. The study seeks to enhance understanding of how fibromyalgia affects the perception of internal bodily states and body position. By comparing the results of fibromyalgia patients with those of healthy individuals, researchers hope to shed light on the psychophysiological aspects of this chronic condition.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 65 diagnosed with fibromyalgia.
Not a fit: Patients with chronic organic disorders or significant mental health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management strategies for fibromyalgia symptoms.
How similar studies have performed: While studies on interoception and proprioception exist, this specific approach in fibromyalgia is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Eligibility criteria healthy controls: Inclusion Criteria: Healthy controls will be selected so that there is an equal ratio between patients and healthy controls for * Age group (per 5 years) * Gender (including X) * Educational attainment * BMI all participants need a score \< 75 on the CSD (Walentynowicz et al., 2018) Exclusion Criteria: * Pregnancy * Under the age of 18 or over the age of 65. * Presence of a depressive episode, anxiety disorder, eating disorder, substance abuse, neurocognitive, or psychotic disorder diagnosed with DSM-V (Diagnostic and Statistical Manual of Mental Disorders; MINI-s; Overbeek et al., 1999). * Presence of a chronic organic disorder (It is referred to as a chronic organic disorder if it has been present for a period of at least 3 months. Examples are: epilepsy, heart disease, rheumatism, asthma, diabetes, etc.) or acute organic disorder (fever, flu, etc.) * Persistent physical complaints (e.g. hyperventilation complaints, long-term COVID, chronic pain or fatigue, chronic tinnitus, etc. ) * Neck complaints at the time of testing * Recent whiplash trauma less than 3 months ago or more than 3 months ago with complaints still present * Diagnosis of vestibular or neurological disorders * Recent orthopedic problems of the lower extremities (e.g. acute ankle trauma) that may affect balance * BMI\>30 Eligibility criteria patients with fibromyalgia Inclusion Criteria: * Patients with fibromyalgia diagnosed using the ACR criteria (Wolfe et al., 2010; 2016). Exclusion Criteria: * Pregnancy * Under the age of 18 or over the age of 65 * Primary depressive episode, anxiety disorder, eating disorder, substance abuse, neurocognitive, or psychotic disorder diagnosed with DSM-V (MINI-s; Overbeek et al., 1999). * Presence of a chronic organic disorder (It is referred to as a chronic organic disorder if it has been present for a period of at least 3 months. Examples are: epilepsy, heart disease, rheumatism, asthma, diabetes, etc.) or acute organic disorder (fever, flu, etc.) * Neck complaints at the time of testing (not related to the current problem) * Recent whiplash trauma less than 3 months ago or more than 3 months ago with symptoms still present * Diagnosis of organically explained vestibular or neurological disorders * Recent orthopedic problems of the lower extremities (e.g., acute ankle trauma) that may affect balance * BMI\>30
Where this trial is running
Diepenbeek, Limburg and 1 other locations
- Hasselt University — Diepenbeek, Limburg, Belgium (Recruiting)
- TRACE labs Ziekenhuis Oost-Limburg (ZOL) — Lanaken, Limburg, Belgium (Recruiting)
Study contacts
- Principal investigator: Katleen Bogaerts, PhD — Hasselt University
- Study coordinator: Indra Ramakers
- Email: indra.ramakers@uhasselt.be
- Phone: +32483082723
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.