Can Electroencephalography (EEG) Identify the Different Dimensions of Pain in Fibromyalgia?
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05962658 |
Recruitment Status :
Completed
First Posted : July 27, 2023
Last Update Posted : August 1, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Fibromyalgia | Other: qEEG |
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 Type : | Observational |
Actual Enrollment : | 21 participants |
Observational Model: | Other |
Time Perspective: | Cross-Sectional |
Official Title: | Electrophysiological Biomarkers of Persons With Fibromyalgia and Its Relation With the Sensitive-discriminative and Affective-motivational Dimensions of Pain |
Actual Study Start Date : | April 1, 2021 |
Actual Primary Completion Date : | July 31, 2021 |
Actual Study Completion Date : | December 31, 2022 |
Group/Cohort | Intervention/treatment |
---|---|
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.
|
Other: qEEG
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. |
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.
|
Other: qEEG
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. |
- qEEG data [ Time Frame: one day ]relative spectral power of the frequency bands (delta, theta, alpha and beta)
- Dimensions of pain [ Time Frame: one day ]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.
- Dimensions of emotional disorders [ Time Frame: one day ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05962658
Brazil | |
Applied Neuroscience Laboratory | |
Recife, Pernambuco, Brazil, 50740-560 |
Principal Investigator: | Kátia Monte-Silva, PhD | PI |
Responsible Party: | Kátia Monte-Silva, Principal Investigator, Universidade Federal de Pernambuco |
ClinicalTrials.gov Identifier: | NCT05962658 |
Other Study ID Numbers: |
Fibro |
First Posted: | July 27, 2023 Key Record Dates |
Last Update Posted: | August 1, 2023 |
Last Verified: | July 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Chronic pain Electroencephalogram |
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |