NCT05907590

Brief Summary

The goal of this observational study is to learn about interoception and proprioception in patients with fibromyalgia. The main questions it aims to answer are:

  • Is there a significant difference in interoception between patients with fibromyalgia and healthy controls?
  • Is there a significant difference in proprioception between patients with fibromyalgia and healthy controls? The participants will perform:
  • The respiratory occlusion discrimination task
  • A postural control task where the effect of muscle vibration on center of gravity displacement is examined
  • The head repositioning accuracy task The participants will also fill out different questionnaires. Researchers will compare healthy controls to see if there is a significant difference.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

1.4 years

First QC Date

May 24, 2023

Last Update Submit

June 7, 2023

Conditions

Fibromyalgia

Keywords

InteroceptionProprioceptionFibromyalgia

Outcome Measures

Primary Outcomes (6)

  • Interoceptive accuracy

    Respiratory occlusion discrimination task (ROD task; Van Den Houte et al., 2021)

    20 minutes

  • Interoceptive sensibility

    Interoceptive Sensitivity and Attention Questionnaire (ISAQ; Bogaerts et al., 2022)

    5 minutes

  • Interoceptive sensibility

    THree-domain Interoceptive Sensations Questionnaire (THISQ; Vlemincx et al., 2021)

    5 minutes

  • Interoceptive awareness

    Visual analogue scale (0-100). A score of 0 indicates that participants are not certain at all of their answer, a score of 100 indicates that participants are entirely certain of their answer.

    5 minutes

  • Proprioceptive accuracy

    Head repositioning accuracy task

    5 minutes

  • Proprioceptive accuracy

    Postural control task

    30 minutes

Secondary Outcomes (8)

  • Psychological variables

    5 minutes

  • Psychological variables

    5 minutes

  • Psychological variables

    5 minutes

  • Psychological variables

    10 minutes

  • Psychological variables

    5 minutes

  • +3 more secondary outcomes

Study Arms (2)

Patients with Fibromyalgia

Patients with fibromyalgia diagnosed using the ACR criteria (American College of Rheumatology, Wolfe et al., 2010; 2016).

Other: Interoceptive accuracy measurementOther: Interoceptive sensibility measurementOther: Interoceptive awareness measurementOther: Proprioceptive accuracy measurement during postural controlOther: Proprioceptive accuracy measurement of the neck

Healthy Controls

Healthy controls will consist of people who experience few physical complaints in daily life. The healthy controls will thus be screened for inclusion using the CSD (Checklist for Symptoms in Daily life; Walentynowicz, et al., 2018). Only volunteers with a score of 75 or lower on this questionnaire will be included

Other: Interoceptive accuracy measurementOther: Interoceptive sensibility measurementOther: Interoceptive awareness measurementOther: Proprioceptive accuracy measurement during postural controlOther: Proprioceptive accuracy measurement of the neck

Interventions

Interoceptive accuracy measurementOTHER

Interoceptive accuracy will be measured using the Respiratory Occlusion Discrimination Task (ROD task; Van Den Houte et al., 2021). The ROD task measures how good subjects are at distinguishing the lengths of short (max 620 milliseconds) inspiratory occlusions (or respiratory interruptions).

Healthy ControlsPatients with Fibromyalgia
Interoceptive sensibility measurementOTHER

Interoceptive sensibility will be measured using two self-report questionnaires, the Interoceptive Sensitivity and Attention Questionnaire (ISAQ; Bogaerts et al., 2022) and the the Three-domain Interoceptive Sensations Questionnaire (THISQ; Vlemincx et al., 2021)

Healthy ControlsPatients with Fibromyalgia
Interoceptive awareness measurementOTHER

Interoceptive awareness will be measures using a visual analogue scale (VAS)

Healthy ControlsPatients with Fibromyalgia
Proprioceptive accuracy measurement during postural controlOTHER

The effect of muscle vibration on center of gravity displacement (center of pressure or COP) will be examined. Muscle vibration of the m. triceps surae ("ankle" muscles) and the lumbar multifidus ("back" muscles) (Johanson et al., 2011; Brumagne et al., 2008; Claeys et al., 2011; Cleays et al., 2015) will be used to examine the role of proprioception during postural control.

Healthy ControlsPatients with Fibromyalgia
Proprioceptive accuracy measurement of the neckOTHER

The head reposition accuracy task will be carried out to assess proprioceptive accuracy of the neck. The most commonly used procedure is the head repositioning accuracy to neutral head position (HRA-to-NHP), first described by Revel and colleagues (1991).

Healthy ControlsPatients with Fibromyalgia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with fibromyalgia diagnosed according to the ACR criteria (Wolfe et al., 2010; 2016) are eligible to participate

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • Patients with fibromyalgia diagnosed using the ACR criteria (Wolfe et al., 2010; 2016).
  • 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).
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hasselt University

Diepenbeek, Limburg, 3590, Belgium

RECRUITING

TRACE labs Ziekenhuis Oost-Limburg (ZOL)

Lanaken, Limburg, 3620, Belgium

RECRUITING

Related Publications (23)

  • Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.

    PMID: 20461783BACKGROUND

  • Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30.

    PMID: 27916278BACKGROUND

  • Khalsa SS, Adolphs R, Cameron OG, Critchley HD, Davenport PW, Feinstein JS, Feusner JD, Garfinkel SN, Lane RD, Mehling WE, Meuret AE, Nemeroff CB, Oppenheimer S, Petzschner FH, Pollatos O, Rhudy JL, Schramm LP, Simmons WK, Stein MB, Stephan KE, Van den Bergh O, Van Diest I, von Leupoldt A, Paulus MP; Interoception Summit 2016 participants. Interoception and Mental Health: A Roadmap. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Jun;3(6):501-513. doi: 10.1016/j.bpsc.2017.12.004. Epub 2017 Dec 28.

    PMID: 29884281BACKGROUND

  • Garfinkel SN, Seth AK, Barrett AB, Suzuki K, Critchley HD. Knowing your own heart: distinguishing interoceptive accuracy from interoceptive awareness. Biol Psychol. 2015 Jan;104:65-74. doi: 10.1016/j.biopsycho.2014.11.004. Epub 2014 Nov 20.

    PMID: 25451381BACKGROUND

  • Tuthill JC, Azim E. Proprioception. Curr Biol. 2018 Mar 5;28(5):R194-R203. doi: 10.1016/j.cub.2018.01.064.

    PMID: 29510103BACKGROUND

  • Walentynowicz, M., Witthöft, M., Raes, F., Van Diest, I., & Van den Bergh, O. (2018). Sensory and affective components of symptom perception: a psychometric approach. Journal of Experimental Psychopathology, 9(2), 1-13. Doi: 10.5127/jep.059716

    BACKGROUND

  • Brumagne S, Janssens L, Knapen S, Claeys K, Suuden-Johanson E. Persons with recurrent low back pain exhibit a rigid postural control strategy. Eur Spine J. 2008 Sep;17(9):1177-84. doi: 10.1007/s00586-008-0709-7. Epub 2008 Jul 2.

    PMID: 18594876BACKGROUND

  • Claeys K, Brumagne S, Dankaerts W, Kiers H, Janssens L. Decreased variability in postural control strategies in young people with non-specific low back pain is associated with altered proprioceptive reweighting. Eur J Appl Physiol. 2011 Jan;111(1):115-23. doi: 10.1007/s00421-010-1637-x. Epub 2010 Sep 8.

    PMID: 20824281BACKGROUND

  • Claeys K, Dankaerts W, Janssens L, Pijnenburg M, Goossens N, Brumagne S. Young individuals with a more ankle-steered proprioceptive control strategy may develop mild non-specific low back pain. J Electromyogr Kinesiol. 2015 Apr;25(2):329-38. doi: 10.1016/j.jelekin.2014.10.013. Epub 2014 Oct 31.

    PMID: 25467548BACKGROUND

  • Johanson E, Brumagne S, Janssens L, Pijnenburg M, Claeys K, Paasuke M. The effect of acute back muscle fatigue on postural control strategy in people with and without recurrent low back pain. Eur Spine J. 2011 Dec;20(12):2152-9. doi: 10.1007/s00586-011-1825-3. Epub 2011 May 1.

    PMID: 21533851BACKGROUND

  • Cordo PJ, Gurfinkel VS, Brumagne S, Flores-Vieira C. Effect of slow, small movement on the vibration-evoked kinesthetic illusion. Exp Brain Res. 2005 Dec;167(3):324-34. doi: 10.1007/s00221-005-0034-x. Epub 2005 Aug 20.

    PMID: 16132974BACKGROUND

  • Revel M, Andre-Deshays C, Minguet M. Cervicocephalic kinesthetic sensibility in patients with cervical pain. Arch Phys Med Rehabil. 1991 Apr;72(5):288-91.

    PMID: 2009044BACKGROUND

  • Van Den Houte M, Vlemincx E, Franssen M, Van Diest I, Van Oudenhove L, Luminet O. The respiratory occlusion discrimination task: A new paradigm to measure respiratory interoceptive accuracy. Psychophysiology. 2021 Apr;58(4):e13760. doi: 10.1111/psyp.13760. Epub 2021 Jan 12.

    PMID: 33438245BACKGROUND

  • Bogaerts K, Walentynowicz M, Van Den Houte M, Constantinou E, Van den Bergh O. The Interoceptive Sensitivity and Attention Questionnaire: Evaluating Aspects of Self-Reported Interoception in Patients With Persistent Somatic Symptoms, Stress-Related Syndromes, and Healthy Controls. Psychosom Med. 2022 Feb-Mar 01;84(2):251-260. doi: 10.1097/PSY.0000000000001038.

    PMID: 34840287BACKGROUND

  • Vlemincx E, Walentynowicz M, Zamariola G, Van Oudenhove L, Luminet O. A novel self-report scale of interoception: the three-domain interoceptive sensations questionnaire (THISQ). Psychol Health. 2023 Sep-Oct;38(9):1234-1253. doi: 10.1080/08870446.2021.2009479. Epub 2021 Dec 7.

    PMID: 34875958BACKGROUND

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    BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Katleen Bogaerts, PhD

    Hasselt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Indra Ramakers

CONTACT

+32483082723indra.ramakers@uhasselt.be

Marleen Missotten

CONTACT

+32(0)11268502CME@uhasselt.be

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD researcher

Study Record Dates

First Submitted

May 24, 2023

First Posted

June 18, 2023

Study Start

July 25, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)