FibromyalgiaNCT05962658
Can Electroencephalography (EEG) Identify the Different Dimensions of Pain in Fibromyalgia?
An observational study of Fibromyalgia, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
Studies with quantitative electroencephalogram (qEEG) in people with fibromyalgia showed the existence of distinct patterns of brain electrical activity when compared to healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- qEEG
- How many people
- 21 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2021to 31 Dec 2022
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women with fibromyalgia enrolled according to the criteria of the American College of Rheumatology (ACR) and 10 healthy volunteers matched by gender and age.
Who may be able to join
- widespread pain index (WPI) ≥ 7;
- symptom severity scale (SS) = 5;
- WPI between 4-6 and (iv) SS ≥ 9;
- generalized pain, as defined as pain in at least 4 regions of the body;
- having been diagnosed with fibromyalgia at least three months ago.
Who cannot join
- autoimmune or inflammatory diseases that cause pain, such as rheumatoid arthritis, systemic lupus erythematosus, or inflammatory bowel disease;
- history of neurological or psychotic disorders;
- cognitive impairment that prevents the conduct of study procedures;
- patients with a history of abusive use of alcohol or other illicit drugs;
- patients who have any contraindication for the use of the qEEG (excessive seborrhoea, scalp infection or pediculosis).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrophysiological Biomarkers of Persons With Fibromyalgia and Its Relation With the Sensitive-discriminative and Affective-motivational Dimensions of Pain
Studies with quantitative electroencephalogram (qEEG) in people with fibromyalgia showed the existence of distinct patterns of brain electrical activity when compared to healthy individuals. Such dysfunctional patterns may be correlated to clinical symptoms of the syndrome as chronic pain and emotional disorders (depression and anxiety). As chronic pain can be considered a multidimensional symptom, its evaluation should consider beyond others, two main dimensions: the sensitive-discriminative dimension and the affective-motivational dimension. Previous studies have been describing distinct brain areas as neural substrates for processing such dimensions of pain. Thus, the identification of electrophysiological biomarkers (i.e., as qEEG measures) allowing to perform an evaluation between dysfunctional patterns of brain electrical activity and different dimensions of pain seems to be a promising path in the search for a better understanding of the syndrome as well as for more individualized and effective therapeutic approaches. Our objective was to investigate whether dysfunctional patterns of brain electrical activity in frontal and central areas of people with fibromyalgia are differently related to dimensions of pain (sensory-discriminative and affective-motivational) and to emotional disorders (depression and anxiety).
Read the detailed description
The study was a pilot study with a cross-sectional and exploratory design carried out from 2020 to 2022. A quantitative electroencephalographic analysis was performed with women with Fibromyalgia and pain-free individuals as a control group, matched for gender and age. The sample was not probabilistic and recruitment occurred in a random manner. All volunteers were recruited from reference services in the state of Pernambuco, referred from other centers as well as through announcements in digital media.
Procedures All procedures were conducted respecting the Declaration of Helsinki (1964) and approved by the local ethical committee. Before clinical and sociodemographic evaluation, all volunteers signed a written informed consent, including all information regarding the risks and benefits of their participation in the study. During the study, all individuals with fibromyalgia were instructed not to change their medication use as well as eating habits. Clinical assessments and qEEG data acquisition took place in one single visit to the laboratory lasting around two hours. After signing the written informed consent, all volunteers were taken to an isolated room to perform an EEG evaluation. Then, they underwent sociodemographic and clinical assessments (only individuals with fibromyalgia).
EEG data acquisition and processing For each volunteer, signals were recorded using digital EEG equipment for 120 seconds in an isolated room - without any communication with the external environment - with volunteers rested, seated in a comfortable chair, and with closed eyes. Signal recording was performed through 19 Ag/AgCl electrodes positioned on the scalp following the predetermined points of the international 10-20 system of electroencephalography and, always maintaining a maximum impedance of 10 kΩ. Additionally, a ground electrode was positioned on the lateral third of the right clavicle, while two reference electrodes were positioned on the region of the right and left mastoid processes. A sampling rate for recording the 500 Hz signal was captured by the NeuronSpectrum signal amplifier and recorded by the Neuron-Spectrum/NET omega software. Additionally, the high-pass (0.5 Hz), low-pass (35 Hz), and notch (60Hz; suitable for 220V mains) filters were applied during data acquisition and processing.
Then, the collected data were pre-processed using the EEGLab toolbox in MATLAB® version R2014a software for Windows. In addition, an Independent Component analysis was performed using the Independent Components Analysis (ICA) algorithm to separate the components related to biological artifacts. The rejection of these components was done through the Multiple Artefact Rejection Algorithm (MARA) considering a 50% cutoff point. For time-frequency analysis of the relative spectral power for each epoch, the fast Fourrier transform method was used. The dominant frequency in each patient was identified in the following points of the international 10-20 EEG system: F3, F4, Fz, F7, F8 (frontal area), and C3, C4, Cz (central area) during rest. Spectral power density assessment was also performed, for each frequency band, considering the following bands: delta (0,5 a ≤ 4 Hz); theta ( > 4 a ≤ 8 Hz); alpha (> 8 a ≤13 Hz) e beta (> 13 a ≤ 30 Hz). For relative spectral power distribution calculations, the absolute spectral power of each frequency band was divided by the total power of all bands present in the 0.5-35Hz.
- Conditions
- Fibromyalgia
- Being tested
- qEEG
- Keywords
- Chronic pain, Electroencephalogram
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qEEGOther
qEEG data was collected with patients and healthy individuals in resting eyes-closed: the relative spectral power of the frequency bands delta, theta, alpha and beta was evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia | Our sample consisted of 11 women with fibromyalgia enrolled according to the criteria of the American College of Rheumatology (ACR). Participants were underwent to clinical and electrophysiological assessments using the McGill Pain Questionnaire, the Hospital Anxiety and Depression Scale, and qEEG in frontal (F3, F4, Fz, F7, F8) and central (C3, C4,Cz) areas. qEEG data was collected with patients in resting eyes-closed: the relative spectral power of the frequency bands delta, theta, alpha and beta was evaluated. Receives: Other: qEEG | |
| Healthy individuals | A control group was enrolled and data was collected from healthy subjects to confirm different patterns of cortical electrical activity in people with fibromyalgia. For that, self-declared healthy and pain-free individuals, matched by gender and age with the women with fibromyalgia included in the sample were recruited through advertising in digital media. Receives: Other: qEEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
qEEG data
relative spectral power of the frequency bands (delta, theta, alpha and beta)
Measured: one day
Secondary outcomes (2)
Dimensions of pain
quality dimensions of pain (sensory-discriminatory and affective-motivational dimensions) were evaluated by McGill Pain Questionnaire. The McGill Pain Questionnaire is a multidimensional easy-to-use assessment of pain that consists of 15 groups of representative words, of which 11 make up the sensory category and 4 the affective category. Each group is classified on a 4-point rating scale according to the intensity of each aspect (0 = none, 1=mild, 2=moderate, and 3=severe). Thus, higher scores represent worse perception of pain. Minimum value: 0; Maximum value: 45.
Measured: one day
Dimensions of emotional disorders
depression and anxiety were investigated by the Hospital Anxiety and Depression Scale - HADS. The scale comprises a 14-item self-report instrument, subdivided into two subscales, one for anxiety and another for depression, containing 7 items each. The score is associated with a Likert-type scale that ranges from 0 to 3, with an evaluation of each subscale ranging from 0 to 21 points or a total score ranging from 0 to 42. The higher the score, the greater the anxiety or depression disorder presented by the individual.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Apr 2021
- Primary completion31 Jul 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kátia Monte-Silva, Universidade Federal de Pernambuco
- Investigators
- Kátia Monte-Silva, PhD, Principal investigator, PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962658
- Sponsor's protocol ID
- Fibro
- Status last verified
- Jul 2023
- First submitted
- 18 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diniz L, Carneiro M, Fonseca A, Shirahige L, Brito R, Melo L, Melo D, Austregesilo M, Piscitelli D, Monte-Silva K. Can electroencephalography (EEG) identify the different dimensions of pain in fibromyalgia? A pilot study. BMC Musculoskelet Disord. 2024 Sep 3;25(1):705. doi: 10.1186/s12891-024-07824-0.
PubMed 39227893
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Biomarkers of Persons With Fibromyalgia and Its Relation With the Sensitive-discriminative and Affective-motivational Dimensions of Pain
- ClinicalTrials.gov ID
- NCT05962658
- Acronym / sponsor ID
- Fibro
- Conditions
- Fibromyalgia
- Keywords
- Chronic pain, Electroencephalogram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 27 Jul 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.
Studies with quantitative electroencephalogram (qEEG) in people with fibromyalgia showed the existence of distinct patterns of brain electrical activity when compared to healthy individuals. Such dysfunctional patterns may be correlated to clinical symptoms of the syndrome as chronic pain and emotional disorders (depression and anxiety). As chronic pain can be considered a multidimensional symptom, its evaluation should consider beyond others, two main dimensions: the sensitive-discriminative dimension and the affective-motivational dimension. Previous studies have been describing distinct brain areas as neural substrates for processing such dimensions of pain. Thus, the identification of electrophysiological biomarkers (i.e., as qEEG measures) allowing to perform an evaluation between dysfunctional patterns of brain electrical activity and different dimensions of pain seems to be a promising path in the search for a better understanding of the syndrome as well as for more individualized and effective therapeutic approaches. Our objective was to investigate whether dysfunctional patterns of brain electrical activity in frontal and central areas of people with fibromyalgia are differently related to dimensions of pain (sensory-discriminative and affective-motivational) and to emotional disorders (depression and anxiety).
Detailed description
The study was a pilot study with a cross-sectional and exploratory design carried out from 2020 to 2022. A quantitative electroencephalographic analysis was performed with women with Fibromyalgia and pain-free individuals as a control group, matched for gender and age. The sample was not probabilistic and recruitment occurred in a random manner. All volunteers were recruited from reference services in the state of Pernambuco, referred from other centers as well as through announcements in digital media.
Procedures All procedures were conducted respecting the Declaration of Helsinki (1964) and approved by the local ethical committee. Before clinical and sociodemographic evaluation, all volunteers signed a written informed consent, including all information regarding the risks and benefits of their participation in the study. During the study, all individuals with fibromyalgia were instructed not to change their medication use as well as eating habits. Clinical assessments and qEEG data acquisition took place in one single visit to the laboratory lasting around two hours. After signing the written informed consent, all volunteers were taken to an isolated room to perform an EEG evaluation. Then, they underwent sociodemographic and clinical assessments (only individuals with fibromyalgia).
EEG data acquisition and processing For each volunteer, signals were recorded using digital EEG equipment for 120 seconds in an isolated room - without any communication with the external environment - with volunteers rested, seated in a comfortable chair, and with closed eyes. Signal recording was performed through 19 Ag/AgCl electrodes positioned on the scalp following the predetermined points of the international 10-20 system of electroencephalography and, always maintaining a maximum impedance of 10 kΩ. Additionally, a ground electrode was positioned on the lateral third of the right clavicle, while two reference electrodes were positioned on the region of the right and left mastoid processes. A sampling rate for recording the 500 Hz signal was captured by the NeuronSpectrum signal amplifier and recorded by the Neuron-Spectrum/NET omega software. Additionally, the high-pass (0.5 Hz), low-pass (35 Hz), and notch (60Hz; suitable for 220V mains) filters were applied during data acquisition and processing.
Then, the collected data were pre-processed using the EEGLab toolbox in MATLAB® version R2014a software for Windows. In addition, an Independent Component analysis was performed using the Independent Components Analysis (ICA) algorithm to separate the components related to biological artifacts. The rejection of these components was done through the Multiple Artefact Rejection Algorithm (MARA) considering a 50% cutoff point. For time-frequency analysis of the relative spectral power for each epoch, the fast Fourrier transform method was used. The dominant frequency in each patient was identified in the following points of the international 10-20 EEG system: F3, F4, Fz, F7, F8 (frontal area), and C3, C4, Cz (central area) during rest. Spectral power density assessment was also performed, for each frequency band, considering the following bands: delta (0,5 a ≤ 4 Hz); theta ( > 4 a ≤ 8 Hz); alpha (> 8 a ≤13 Hz) e beta (> 13 a ≤ 30 Hz). For relative spectral power distribution calculations, the absolute spectral power of each frequency band was divided by the total power of all bands present in the 0.5-35Hz.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia | – | Other: qEEGOur sample consisted of 11 women with fibromyalgia enrolled according to the criteria of the American College of Rheumatology (ACR). Participants were underwent to clinical and electrophysiological assessments using the McGill Pain Questionnaire, the Hospital Anxiety and Depression Scale, and qEEG in frontal (F3, F4, Fz, F7, F8) and central (C3, C4,Cz) areas. qEEG data was collected with patients in resting eyes-closed: the relative spectral power of the frequency bands delta, theta, alpha and beta was evaluated. |
| Healthy individuals | – | Other: qEEGA control group was enrolled and data was collected from healthy subjects to confirm different patterns of cortical electrical activity in people with fibromyalgia. For that, self-declared healthy and pain-free individuals, matched by gender and age with the women with fibromyalgia included in the sample were recruited through advertising in digital media. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with fibromyalgia enrolled according to the criteria of the American College of Rheumatology (ACR) and 10 healthy volunteers matched by gender and age.
Key inclusion criteria (5 listed)
- widespread pain index (WPI) ≥ 7;
- symptom severity scale (SS) = 5;
- WPI between 4-6 and (iv) SS ≥ 9;
- generalized pain, as defined as pain in at least 4 regions of the body;
- having been diagnosed with fibromyalgia at least three months ago.
Key exclusion criteria (5 listed)
- autoimmune or inflammatory diseases that cause pain, such as rheumatoid arthritis, systemic lupus erythematosus, or inflammatory bowel disease;
- history of neurological or psychotic disorders;
- cognitive impairment that prevents the conduct of study procedures;
- patients with a history of abusive use of alcohol or other illicit drugs;
- patients who have any contraindication for the use of the qEEG (excessive seborrhoea, scalp infection or pediculosis).
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 |
|---|---|---|
| qEEGqEEG data was collected with patients and healthy individuals in resting eyes-closed: the relative spectral power of the frequency bands delta, theta, alpha and beta was evaluated. | Other | Fibromyalgia, Healthy individuals |
Primary outcome
qEEG data
Time frame: one day
relative spectral power of the frequency bands (delta, theta, alpha and beta)
2 secondary outcomes
Dimensions of pain
Time frame: one day
Dimensions of emotional disorders
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Derived from this study: PubMed 39227893Diniz L, Carneiro M, Fonseca A, Shirahige L, Brito R, Melo L, Melo D, Austregesilo M, Piscitelli D, Monte-Silva K. Can electroencephalography (EEG) identify the different dimensions of pain in fibromyalgia? A pilot study. BMC Musculoskelet Disord. 2024 Sep 3;25(1):705. doi: 10.1186/s12891-024-07824-0.
- Individual participant dataSharing planned: No
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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.
Kátia Monte-Silva, PhD principal investigator
PI
1 site 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 Universidade Federal de Pernambuco at 1 site in Brazil.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
qEEG data (time frame: one day). 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 NCT05962658, which also lists 1 linked publication.
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 1 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.