FibromyalgiaNCT05907590
Proprioception and Interoception in Patients With Fibromyalgia
An observational study of Fibromyalgia, run by Hasselt University at 2 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Interoceptive accuracy measurement, Interoceptive sensibility measurement and Interoceptive awareness measurement
- How many people
- 52 participants
- Where
- 2 sitesBelgium
- Study dates
- 25 Jul 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients with fibromyalgia diagnosed according to the ACR criteria (Wolfe et al., 2010; 2016) are eligible to participate
Who may be able to join
- 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)
- Patients with fibromyalgia diagnosed using the ACR criteria (Wolfe et al., 2010; 2016).
Who cannot join
- 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
Show all 20Show fewer
- 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
- 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
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
Hasselt University
Diepenbeek, Limburg, 3590
Indra Ramakers, +32483082723, indra.ramakers@uhasselt.be
- Recruiting
TRACE labs Ziekenhuis Oost-Limburg (ZOL)
Lanaken, Limburg, 3620
Indra Ramakers, +32483082723, indra.ramakers@uhasselt.be
About this study
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?
Read more
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.
Read the detailed description
Fibromyalgia is a chronic widespread pain condition characterized by point tenderness, fatigue, sleep disturbance, cognitive complaints, and increasing somatic complaints. With this case-control study we want to emphasize the importance of an integrative psychophysiological model for fibromyalgia, in which interoception and proprioception are being investigated.
Interoception has been described in the literature as "the overall process of how the nervous system senses, integrates, stores and displays information about the state of the internal body". Theory suggests that interoception should be divided into three measurable constructs: interoceptive accuracy (objective accuracy in detecting internal bodily sensations), interoceptive sensitivity (the self-perceived tendency to be internally self-focused), and interoceptive awareness (metacognition about his/her own interoceptive accuracy). Proprioception on the other hand, is described as the sense of body position and movement.
The first measurement will take place in the lab of REVAL Hasselt University. First, informed consent will be signed before any data collection takes place. This part of the experiment will take approximately 30 minutes.
Two proprioception tasks will be performed consecutively. The effect of muscle vibration on centre 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) will be used to examine the role of proprioception during postural control. The displacement (magnitude) of the COP during standing will be assessed with a force plate. The muscle vibration induces muscle extension illusions, so that, in order to maintain balance, the subject, by a compensatory mechanism, will send the COP to the opposite side when he or she effectively uses the proprioceptors (muscle spindles) of the vibrated muscle. The same task will be performed on both a stable and an unstable surface.
The head reposition accuracy task will be carried out to assess neck proprioception. The most commonly used procedure is the head repositioning accuracy to neutral head position (HRA-to-NHP). During this procedure, the subject sits against a backrest. The subject is blindfolded to exclude visual input and wears a helmet containing a beam of light directed at a target 90 cm in front of the subject. The subject is instructed to look straight ahead and memorize this position. At that point, the test leader will mark off this point on the target. Subject's head is turned at an angle by the subject (active). Test subject will hereafter have to actively move the head back to the initial position. The direction of movement used are rotations, both to the left and to the right.
The second part of the experiment will take place in the TRACE labs of Ziekenhuis Oost Limburg (ZOL). It will take approximately 30 minutes. Participants will start with the interoceptive accuracy task using the Respiratory Occlusion Discrimination Task (ROD task). The ROD task measures how good subjects are at distinguishing the lengths of short (max 620 milliseconds) inspiratory occlusions (or respiratory interruptions). Occlusions of these lengths are not aversive or unpleasant. One trial consists of two occlusions within one inspiration (inter-occlusion interval = 300 milliseconds), one occlusion being the reference occlusion (always 440 milliseconds) and one occlusion being the test occlusion (longer or shorter than 440 milliseconds), administered in random order. The participant is asked to indicate which of the two occlusions was longest. An adaptive staircase paradigm is thus used to determine the just noticeable difference in lengths of inspiratory occlusions. The length of the task depends on the performance of the subject, but is on average 56 trials (= 15 minutes). After the experiment, another short side experiment of 16 trials will be conducted in which the participant should indicate how confident they were in their response on a Visual Analogue scale (VAS), in order to estimate interoceptive awareness. In the meantime, participants will be also asked to complete a questionnaire bundle at home (online), which takes approximately 45 minutes to complete.
The power calculations resulted in a total of 26 persons per group. Therefore the investigators plan to recruit a total of 52 people.
Primary outcomes are interoceptive accuracy, interoceptive sensibility, interoceptive awareness, and proprioceptive accuracy. Secondary outcome measures are psychological variables measured using questionnaires.
Descriptive statistics will be used to display baseline group characteristics. To evaluate between-group differences (i.e. the difference between patients with fibromyalgia and healthy controls regarding interoception, proprioception and psychological variables) t-tests will be used.
- Conditions
- Fibromyalgia
- Being tested
- Interoceptive accuracy measurement, Interoceptive sensibility measurement, Interoceptive awareness measurement, Proprioceptive accuracy measurement during postural control, Proprioceptive accuracy measurement of the neck
- Keywords
- Interoception, Proprioception, Fibromyalgia
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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)
Interoceptive awareness measurementOther
Interoceptive awareness will be measures using a visual analogue scale (VAS)
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.
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients with Fibromyalgia | Patients with fibromyalgia diagnosed using the ACR criteria (American College of Rheumatology, Wolfe et al., 2010; 2016). Receives: Other: Interoceptive accuracy measurement; Other: Interoceptive sensibility measurement; Other: Interoceptive awareness measurement; Other: Proprioceptive accuracy measurement during postural control; Other: 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 Receives: Other: Interoceptive accuracy measurement; Other: Interoceptive sensibility measurement; Other: Interoceptive awareness measurement; Other: Proprioceptive accuracy measurement during postural control; Other: Proprioceptive accuracy measurement of the neck |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interoceptive accuracy
Respiratory occlusion discrimination task (ROD task; Van Den Houte et al., 2021)
Measured: 20 minutes
Interoceptive sensibility
Interoceptive Sensitivity and Attention Questionnaire (ISAQ; Bogaerts et al., 2022)
Measured: 5 minutes
Interoceptive sensibility
THree-domain Interoceptive Sensations Questionnaire (THISQ; Vlemincx et al., 2021)
Measured: 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.
Measured: 5 minutes
Proprioceptive accuracy
Head repositioning accuracy task
Measured: 5 minutes
Proprioceptive accuracy
Postural control task
Measured: 30 minutes
Secondary outcomes (8)
Psychological variables
Checklist for Symptoms in Daily Life (CSD; Walentynowicz et al., 2018)
Checklist for Symptoms in Daily Life (CSD; Walentynowicz et al., 2018)
Checklist for Symptoms in Daily Life (CSD; Walentynowicz et al., 2018)
Checklist for Symptoms in Daily Life (CSD; Walentynowicz et al., 2018)
Measured: 5 minutes
Psychological variables
Positive and Negative Affect Scale (PANAS; Watson et al., 1988)
Measured: 5 minutes
Psychological variables
Tellegen Absorption Scale (TAS; Tellegen \& Atkinson, 1974)
Measured: 5 minutes
Psychological variables
Traumatic Experiences Checklist (TEC; Nijenhuis et al., 2002)
Measured: 10 minutes
Psychological variables
Toronto Alexithymia Scale (TAS-20; Bagby et al., 1994)
Measured: 5 minutes
Psychological variables
Need for Controllability and Predictability Questionnaire (NCP-q; Ramakers et al., manuscript in preparation)
Measured: 5 minutes
Psychological variables
Frost Multidimensional Perfectionism Scale (FMPS; Frost et al., 1990)
Measured: 5 minutes
Psychological variables
Acceptance and Action Questionnaire-II (AAQ-II; Bond et al., 2011)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start25 Jul 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- TRACE labs Ziekenhuis Oost-Limburg (ZOL)
- Responsible party
- Principal investigator, Indra Ramakers, Hasselt University
- Investigators
- Katleen Bogaerts, PhD, Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907590
- Sponsor's protocol ID
- B1152022000007
- Status last verified
- Jun 2023
- First submitted
- 24 May 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20461783Wolfe 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.
PubMed 27916278Khalsa 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.
PubMed 29884281Garfinkel 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.
PubMed 25451381Tuthill JC, Azim E. Proprioception. Curr Biol. 2018 Mar 5;28(5):R194-R203. doi: 10.1016/j.cub.2018.01.064.
PubMed 29510103Walentynowicz, 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
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.
PubMed 18594876Claeys 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.
PubMed 20824281Claeys 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.
PubMed 25467548Johanson 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.
PubMed 21533851Cordo 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.
PubMed 16132974Revel M, Andre-Deshays C, Minguet M. Cervicocephalic kinesthetic sensibility in patients with cervical pain. Arch Phys Med Rehabil. 1991 Apr;72(5):288-91.
PubMed 2009044Van 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.
PubMed 33438245Bogaerts 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.
PubMed 34840287Vlemincx 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.
PubMed 34875958
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proprioception and Interoception in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT05907590
- Acronym / sponsor ID
- B1152022000007
- Conditions
- Fibromyalgia
- Keywords
- Interoception, Proprioception, Fibromyalgia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- TRACE labs Ziekenhuis Oost-Limburg (ZOL)
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fibromyalgia is a chronic widespread pain condition characterized by point tenderness, fatigue, sleep disturbance, cognitive complaints, and increasing somatic complaints. With this case-control study we want to emphasize the importance of an integrative psychophysiological model for fibromyalgia, in which interoception and proprioception are being investigated.
Interoception has been described in the literature as "the overall process of how the nervous system senses, integrates, stores and displays information about the state of the internal body". Theory suggests that interoception should be divided into three measurable constructs: interoceptive accuracy (objective accuracy in detecting internal bodily sensations), interoceptive sensitivity (the self-perceived tendency to be internally self-focused), and interoceptive awareness (metacognition about his/her own interoceptive accuracy). Proprioception on the other hand, is described as the sense of body position and movement.
The first measurement will take place in the lab of REVAL Hasselt University. First, informed consent will be signed before any data collection takes place. This part of the experiment will take approximately 30 minutes.
Two proprioception tasks will be performed consecutively. The effect of muscle vibration on centre 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) will be used to examine the role of proprioception during postural control. The displacement (magnitude) of the COP during standing will be assessed with a force plate. The muscle vibration induces muscle extension illusions, so that, in order to maintain balance, the subject, by a compensatory mechanism, will send the COP to the opposite side when he or she effectively uses the proprioceptors (muscle spindles) of the vibrated muscle. The same task will be performed on both a stable and an unstable surface.
The head reposition accuracy task will be carried out to assess neck proprioception. The most commonly used procedure is the head repositioning accuracy to neutral head position (HRA-to-NHP). During this procedure, the subject sits against a backrest. The subject is blindfolded to exclude visual input and wears a helmet containing a beam of light directed at a target 90 cm in front of the subject. The subject is instructed to look straight ahead and memorize this position. At that point, the test leader will mark off this point on the target. Subject's head is turned at an angle by the subject (active). Test subject will hereafter have to actively move the head back to the initial position. The direction of movement used are rotations, both to the left and to the right.
The second part of the experiment will take place in the TRACE labs of Ziekenhuis Oost Limburg (ZOL). It will take approximately 30 minutes. Participants will start with the interoceptive accuracy task using the Respiratory Occlusion Discrimination Task (ROD task). The ROD task measures how good subjects are at distinguishing the lengths of short (max 620 milliseconds) inspiratory occlusions (or respiratory interruptions). Occlusions of these lengths are not aversive or unpleasant. One trial consists of two occlusions within one inspiration (inter-occlusion interval = 300 milliseconds), one occlusion being the reference occlusion (always 440 milliseconds) and one occlusion being the test occlusion (longer or shorter than 440 milliseconds), administered in random order. The participant is asked to indicate which of the two occlusions was longest. An adaptive staircase paradigm is thus used to determine the just noticeable difference in lengths of inspiratory occlusions. The length of the task depends on the performance of the subject, but is on average 56 trials (= 15 minutes). After the experiment, another short side experiment of 16 trials will be conducted in which the participant should indicate how confident they were in their response on a Visual Analogue scale (VAS), in order to estimate interoceptive awareness. In the meantime, participants will be also asked to complete a questionnaire bundle at home (online), which takes approximately 45 minutes to complete.
The power calculations resulted in a total of 26 persons per group. Therefore the investigators plan to recruit a total of 52 people.
Primary outcomes are interoceptive accuracy, interoceptive sensibility, interoceptive awareness, and proprioceptive accuracy. Secondary outcome measures are psychological variables measured using questionnaires.
Descriptive statistics will be used to display baseline group characteristics. To evaluate between-group differences (i.e. the difference between patients with fibromyalgia and healthy controls regarding interoception, proprioception and psychological variables) t-tests will be used.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Fibromyalgia | – | Other: Interoceptive accuracy measurement, Other: Interoceptive sensibility measurement, Other: Interoceptive awareness measurement, Other: Proprioceptive accuracy measurement during postural control, Other: Proprioceptive accuracy measurement of the neckPatients with fibromyalgia diagnosed using the ACR criteria (American College of Rheumatology, Wolfe et al., 2010; 2016). |
| Healthy Controls | – | Other: Interoceptive accuracy measurement, Other: Interoceptive sensibility measurement, Other: Interoceptive awareness measurement, Other: Proprioceptive accuracy measurement during postural control, Other: Proprioceptive accuracy measurement of the neckHealthy 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with fibromyalgia diagnosed according to the ACR criteria (Wolfe et al., 2010; 2016) are eligible to participate
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- 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. )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interoceptive accuracy measurementInteroceptive 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). | Other | Healthy Controls, Patients with Fibromyalgia |
| Interoceptive sensibility measurementInteroceptive 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) | Other | Healthy Controls, Patients with Fibromyalgia |
| Interoceptive awareness measurementInteroceptive awareness will be measures using a visual analogue scale (VAS) | Other | Healthy Controls, Patients with Fibromyalgia |
| Proprioceptive accuracy measurement during postural controlThe 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. | Other | Healthy Controls, Patients with Fibromyalgia |
| Proprioceptive accuracy measurement of the neckThe 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). | Other | Healthy Controls, Patients with Fibromyalgia |
Primary outcome
Interoceptive accuracy
Time frame: 20 minutes
Respiratory occlusion discrimination task (ROD task; Van Den Houte et al., 2021)
Interoceptive sensibility
Time frame: 5 minutes
Interoceptive Sensitivity and Attention Questionnaire (ISAQ; Bogaerts et al., 2022)
Interoceptive sensibility
Time frame: 5 minutes
THree-domain Interoceptive Sensations Questionnaire (THISQ; Vlemincx et al., 2021)
Interoceptive awareness
Time frame: 5 minutes
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.
Proprioceptive accuracy
Time frame: 5 minutes
Head repositioning accuracy task
Proprioceptive accuracy
Time frame: 30 minutes
Postural control task
8 secondary outcomes
Psychological variables
Time frame: 5 minutes
Psychological variables
Time frame: 5 minutes
Psychological variables
Time frame: 5 minutes
Psychological variables
Time frame: 10 minutes
Psychological variables
Time frame: 5 minutes
Psychological variables
Time frame: 5 minutes
Psychological variables
Time frame: 5 minutes
Psychological variables
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Background: PubMed 20461783Wolfe 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.
- Background: PubMed 27916278Wolfe 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.
- Background: PubMed 29884281Khalsa 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.
- Background: PubMed 25451381Garfinkel 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.
- Background: PubMed 29510103Tuthill JC, Azim E. Proprioception. Curr Biol. 2018 Mar 5;28(5):R194-R203. doi: 10.1016/j.cub.2018.01.064.
- BackgroundWalentynowicz, 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: PubMed 18594876Brumagne 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.
- Background: PubMed 20824281Claeys 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.
- Background: PubMed 25467548Claeys 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.
- Background: PubMed 21533851Johanson 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.
- Background: PubMed 16132974Cordo 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.
- Background: PubMed 2009044Revel M, Andre-Deshays C, Minguet M. Cervicocephalic kinesthetic sensibility in patients with cervical pain. Arch Phys Med Rehabil. 1991 Apr;72(5):288-91.
- Individual participant dataSharing planned: No
Related trials for Fibromyalgia
Not yet recruitingObservational study
Validity, Reliability, and Clinical Correlates of Immersive Virtual Reality Adaptation of the Five Times Sit-to-stand Test and Timed up and go Tests in Women With Fibromyalgia Syndrome
Fibromyalgia Syndrome
Active, not recruiting
Comparing Instrument-Assisted Soft Tissue Mobilization and Muscle Energy Technique for Myofascial Pain Syndrome in Women
Myofascial Pain Syndrome
Not yet recruitingObservational study
Daily Cognitive Failures and Medication Adherence in Fibromyalgia
Fibromyalgia
Not yet recruiting
Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation
Fibromyalgia
Not yet recruitingObservational study
Agreement Between CSI and IASP Pain Classification in Chronic Cervical Myofascial Pain
Myofascial Pain Syndrome - Neck
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katleen Bogaerts, PhD principal investigator
Hasselt University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Hasselt University at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Indra Ramakers (+32483082723, indra.ramakers@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interoceptive accuracy (time frame: 20 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05907590, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.