An observational study in Fibromyalgia, Chronic Fatigue Syndrome and Comorbidities and Coexisting Conditions, sponsored by University of Extremadura. Active, not recruiting at 1 site in Spain. Open to female participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by University of Extremadura · Observational
The purpose of this study is to evaluate differences in neuroimmunoendocrine response and quality of live in patients diagnosed with Fibromyalgia, with or without a co-diagnosis of Chronic Fatigue Syndrome.
The limited literature published in concordant relation affects the chronic fatigue syndrome comorbidity in the daily life of fibromyalgia patients leads us to design this study with the main objective of evaluating differences in the quality of life associated with pain and stress, mainly in relation to levels of physical activity, sedentary lifestyle and sleep in patients diagnosed with fibromyalgia, with or without a parallel co-diagnosis of chronic fatigue syndrome.
1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.
This study's planned enrollment of 140 is above the median of 100 across 270 observational studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →University of Extremadura is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The present investigation is carried out in two experimental groups: patients diagnosed with Fibromyalgia and patients diagnosed with Fibromyalgia and a co-diagnosis of Chronic Fatigue Syndrome, all of them volunteers facilitated through the Fibromyalgia Associations of Badajoz and Cáceres, Extremadura, Spain.
Exclusion Criteria:
Aged-matched control group of healthy women.
Behavioral: Subjective quality of live · Procedure: Blood extraction · Behavioral: Accelerometry
Patients diagnosed only with fibromyalgia.
Behavioral: Subjective quality of live · Procedure: Blood extraction · Behavioral: Accelerometry · Dietary Supplement: Synbiotic complement
Patients diagnosed with fibromyalgia and chronic fatigue syndrome.
Behavioral: Subjective quality of live · Procedure: Blood extraction · Behavioral: Accelerometry · Dietary Supplement: Synbiotic complement
The groups fill out scientifically validated questionnaires to know the differences in perceived stress, anxiety, quality of life, depression, quality of sleep, pain, fatigue, and impact of the disease on daily life.
Blood collection by qualified personnel.
To know the objective differences between physical activity/sedentary lifestyle, caloric expenditure and quality of sleep, we used the accelerometry technique
On two separate days, the "baseline-tests" and "final-tests" were conducted. All participants performed a series of tests, before which they had to fast. The order and schedule (8 am) of the tests was the same for the "final-test" and the same materials and procedures were used. A period of 30 consecutive days elapsed between the base-line and final tests, during which the participants had to ingest their supplement (synbiotic).
Differences in perceived anxiety using the State-Trait Anxiety Inventory (STAI)
State-Trait Anxiety Inventory (STAI) is a self-reported, scientifically validated questionnaire that measures perceived anxiety. The STAI has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Time frame: During the intervention, at day 1.
Differences in perceived stress using The Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS) is a self-reported, scientifically validated questionnaire that measures perceived stress. This scale is a self- report instrument that evaluates the level of perceived stress during the last month, and consists of 14 items with a 5-point response scale (0 = never, 1 = almost never, 2 = once in a while, 3 = often, 4 = very often). The total score of the PSS is obtained by reversing the scores of items 4, 5, 6, 7, 9, 10, and 13 (in the following manner: 0 = 4, 1 = 3, 2 = 2, 3 = 1, and 4 = 0) and subsequently adding the 14 item scores. A higher score indicates a higher level of perceived stress.
Time frame: During the intervention, at day 1.
Differences in perceived depression using the Beck's Depression Inventory (BDI)
Beck's Depression Inventory (BDI) is a self-reported, scientifically validated questionnaire that measures perceived depression. Each of the 21 items on the BDI measures the presence and severity of a symptom of depression by requiring a self-rating from 0 to 3. Mild (low) scores are less than 4; moderate (medium) is between 14 and 20, and severe 21 and above. Unless otherwise indicated, the use of "mild," "moderate," and "severe" levels of depression throughout the remainder of this chapter will refer to the aforementioned ranges.
Time frame: During the intervention, at day 1.
Differences in perceived pain using the Brief Pain Inventory (BPI)
Brief Pain Inventory (BPI) is a self-reported, scientifically validated questionnaire that measures perceived pain. The BPI starts with a screening question, asking about the presence of pain and a body chart is used to indicate painful regions as well as the worst region. These items aren´t evaluated. This is followed by the core BPI items: the rating scales for pain severity and interference. Numerical rating scales from 0 to 10 are used for all items. The anchors for pain severity scales are 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whilst the interference anchors are 0 = 'no interference' and 10 = 'interferes completely'.
Time frame: During the intervention, at day 1.
Differences in perceived pain using the Brief Fatigue Inventory (BFI)
The Brief Fatigue Inventory (BFI) has nine items, with the items measured on 0-10 numeric rating scales. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and"now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The interference items are measured on a 0 -10 scale, with 0 beings "does not interfere" and 10 being "completely interferes."
Time frame: During the intervention, at day 1.
Differences in subjective quality of sleep using The Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality lndex (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21 " indicating severe difficulties in all areas.
Time frame: During the intervention, at day 1.
Differences in subjective quality of life using The Healthy Lifestyle and Personal Control Questionnaire (HLPCQ)
The Healthy Lifestyle and Personal Control Questionnaire (HLPCQ) This is a 26-item tool in which the respondent is asked to indicate the frequency of adopting 26 positively stated lifestyle habits using a Likert-type scale (1=Never or rarely, 2=Sometimes, 3=Often, and 4 = Always).
Time frame: During the intervention, at day 1.
Differences in perceived anxiety related to Coronavirus Disease (COVID-19) using the Coronavirus Anxiety Scale (CAS)
The Coronavirus Anxiety Scale is a brief mental health screener that can be used to identify cases of dysfunctional anxiety related to COVID-19. The items measure physiologically-based symptoms that are aroused with coronavirus-related information and thoughts using a 5-point time anchored scale (0=not at all to 4=nearly every day over the last 2 weeks).
Time frame: During the intervention, at day 1.
Differences in fear of Coronavirus Disease (COVID-19) using the Fear COVID-19 Scale (FCV-19S)
The Fear of COVID-19 Scale (FCV-19S) is used to identify and intervene early, psychologically, in people with high values of fear of COVID-19. This one-dimensional scale is made up of seven items with a 5-point Likert response ranging from 1 (strongly disagree) to 5 (strongly agree) and the total tables can range between 7 and 35 points. The higher the score, the greater the fear of COVID-19 infection.
Time frame: During the intervention, at day 1.
Objective differences in physical activity, sedentary lifestyle and sleep using the accelerometer technique (ActiGraph)
An accelerometer is a small device, like a wristwatch, used to measure physical activity level, patterns of activity, sedentary levels, sleep patterns, and the expenditure of calories consumed, basal and total Metabolic Equivalent of Task (METs) used as an assessment of the metabolism of the person wearing it.
Time frame: Up to 1 week
Determination of immuno-neuroendocrine parameters (cytokines, catecholamines, and stress hormones)
Cytokines (IL-8, IL-10), catecholamines (such as epinephrine, and norepinephrine) as well as stress hormones (serotonin and cortisol), were analyzed by competitive inhibition enzyme immunoassays (ELISA)
Time frame: Through study completion, an average of 2 year
Plan to share: No
This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Extremadura