An interventional study of Experimental: Active care group and Active Comparator: Self-care group in Fibromyalgia and Fibromyalgia, Primary, sponsored by Federal University of Pelotas. Completed at 1 site in Brazil. Open to female participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Federal University of Pelotas · Not applicable, Interventional, and Treatment
Among 60 studies in Fibromyalgia with a site in Brazil — 6 open to participants now, 8 under way, none of them phase 3. Fibromyalgia · Brazil.
Among the 60 studies in Fibromyalgia with a site in Brazil, this one is the 50th largest by enrollment of the 58 interventional ones, is one of 5 that started in 2021, is one of 39 with no phase, and was the 44th registered.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's enrollment of 28 is below the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →6 of the 60 studies in Fibromyalgia with a site in Brazil are open now, in 1 country. Each count lists the studies.
Of the 160 Fibromyalgia studies recruiting now, 50 (31%) set no upper age limit and 96 (60%) stop at 75 or younger; 14 take children under 18; 35 take healthy volunteers.
This study: 30 Years to 60 Years · female · no healthy volunteers.
The full table on the hub →60 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 5 started in 2021.
Median enrollment 60 across the 58 interventional studies, 72 across the 2 observational. Of the 33 that completed or were terminated, 2 (6%) have results posted.
1 of 60 have an industry lead sponsor. The 10 most frequent:
Federal University of Pelotas is the lead sponsor of 52 studies on the registry; 4 are open to participants now.
Federal University of Pelotas has 1 study filed under Fibromyalgia — fewer than ten, so there is no comparison to draw.
2 of the studies in Fibromyalgia with a site in Brazil that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07821034Federal University of the Valleys of Jequitinhonha and MucuriEffects of Reiki Therapy in Women With Fibromyalgia | 2026-12-15 |
| NCT07783295Associação Pan-Americana Multidisciplinar de EndocanabinologiaFull-Spectrum Cannabis Extract for Chronic Pain and Bone Health Biomarkers in Women | 2027-09-01 |
Among the 60 studies in Fibromyalgia with a site in Brazil, from their registry updates:
Nothing recorded among them since 2026-09-25.
This study is a randomized, single-blinded, parallel, superiority, controlled trial. The main objective is to verify the effects of a telehealth stretching exercise program on pain, depression, sleep parameters and functionality of women with fibromyalgia, during the Covid-19 pandemic. Participants will be women with primary fibromyalgia, seen at public and private health services, in the region south of Brazil. Participants will be recruited through social networks, newspapers and support from the National Association of Fibromyalgia and Correlated Diseases (Anfibro). Eligible participants will be randomized, stratified by age (30 to 45; 46 to 60), and allocated to one of the two groups, experimental or control. The experimental group will receive a telehealth stretching exercise program twice a week (guided by a professional) and counseling guide to stretching exercises with explanatory video regarding the execution of the protocol proposed by the guide. The total duration of exercise program will be 40 minutes (will be 12 exercise, 3 sets of each stretching for 10 seconds, carried out individually by a video call application - WhatsApp). The control group will receive only counseling guide to stretching exercises with explanatory video regarding the execution of the protocol. Both interventions will last 12 weeks, with outcomes evaluations in three moments: baseline (week 0), midpoint (week 6) and after the intervention (week 13). The following outcomes will be evaluated: generalized index of pain, fatigue and severity of symptoms, depression, level of physical activity, functionality, quality of life and sleep. All outcomes will be evaluated by questionnaires self-completed, that will be answered on Google Docs by video call, with exception of functional test that will be applied by video call. The study's hypothesis consists of improving outcomes for both groups, but with superiority for the experimental group.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will practice stretching exercises twice a week, at a distance and under the supervision of a professional, for 12 weeks. In addition, the experimental group will receive the same written guide and video of the comparator group.
Other: Experimental: Active care group
Participants will receive stretching advice by written guide and video with stretching exercises, to be performed individually, without distance supervision, for 12 weeks. Participants will be able to resolve questions about the protocol at any time, via telephone.
Other: Active Comparator: Self-care group
Stretching exercise program remotely supervised. Total of approximately 40 minutes per session by WhatsApp, individually and supervised by a professional (physiotherapist or physical education teacher). As recommended for flexibility improving, 30 seconds of stretching in each exercise will be perform fractionated (3 series of 10 seconds of static position at the point of moderate discomfort, with 10 seconds interval between series). There will be two stretching protocol models with exercises variations, but for the same muscle groups, intensity, volume, and duration. The position at the point of moderate discomfort will be self-adjusted by subjective perception over 12 weeks of intervention. The protocol model will change after seven weeks. In order to make the interventions more similar, the guide and videos of control group will be also sent to experimental group
The participants will receive counseling to stretching by guide and explanatory video that will be send by WhatsApp. The stretching exercise protocols will be the same performed by the experimental group. In addition, participants will receive recommendation to perform the protocol with the same weekly frequency, intensity, volume, and duration perform by the experimental group After the guide and explanatory video are sent, participants will receive a call for clarification. As well as in the experimental group, the protocol model will change after seven weeks; so, other guide and explanatory video will be sent for participants.
Changes in the Widespread Pain Index
A generalized pain index is a tool used to measure the amplitude of patients' clinical symptoms with fibromyalgia. It is considered a diagnostic scale, presenting 90.8% accuracy about the American College of Rheumatology's first criteria, de1990 and validated by the same institution in 2010 (WOLFE et al., 2010) being recognized by the Brazilian Society of Rheumatology - SBR, in 2017. Comprises the body areas usually affected by the disease, where the patient indicates if he felt pain at that moment in the last seven days (HEYMANN et al., 2017). Scores considered high are higher than 7. It will be checked if there was a change in painful behavior through collections in three periods of time, which will be compared at the end of the treatment.
Time frame: Zero week, six week, and twelve week
Changes in Sleep Quality
The Pittsburgh Sleep Quality Index Self-Report Questionnaire has been widely used to record sleep for four weeks. It includes 19 self-reported questions, divided into seven domains (HERNÁNDEZ et al., 2020) and five questions to be answered by the roommate, with questions about the noise produced during sleep. The score ranges from 0 to 3, where higher scores indicate worse sleep quality (BERTOLAZI et al., 2011). It was developed in 1989 by Buysse et al. and validated in the Brazilian version in 2011 by Bertolazi et al. (PASSOS et al., 2017). It is hoped to find a change in sleep quality; thus, three collections will be made, at different times of time, which will be compared at the end of the treatment.
Time frame: Zero week, six week, and twelve week
Symptom Severity Scale
Symptom Severity, based on analyzing the primary symptoms reported in fibromyalgia, such as fatigue, sleep, and cognition, is considered a diagnostic criterion, with a sensitivity of 90.9% and specificity of 85.9% (HEYMANN et al., 2017). It comprises four domains, with scores ranging from 0 to 3, and scores above five are considered relevant. Validated by the American College of Rheumatology in 2010 (WOLFE et al., 2010) and recognized by the Brazilian Society of Rheumatology - SBR, 2017.
Time frame: Zero week, six week, and twelve week
Impact of fibromyalgia on daily activities
Fibromyalgia Impact Questionnaire (FIQ) is a survey that looks at the severity of the pathology on the individual's functional capacity and the perception of the quality of life. Their scores range from 0 to 100, where higher values indicate a more significant disease impact. Scores are expressed as follows: from 0 to 38 mild effect, from 39 to 58 moderate effect, and from 59 to 100 severe impact (UMAY et al., 2019) and validated in 1991 by Burckhardt et al., Translated and adapted for the Brazilian version in 2006, by Marques et al. (MARQUES et al., 2006).
Time frame: Zero week, six week, and twelve week
Depressive symptoms
Beck's Depression Inventory (BDI) is a tool whose purpose is to analyze the perception of depressive symptoms, developed and revised in 1996 by Becket al., And validated in the Brazilian version in 2012, by Gomes-Oliveira et al. (GOMES- OLIVEIRA et al., 2012). It includes 21 items, with scores ranging from 0 to 3, where the maximum score is 63, indicating severity. Values between 0 and 13 show minimal symptoms, 14 to 19 medium symptoms, 20 to 28 moderate, and 29 or more indicate severe depression (ALVENTOSA et al., 2020). Among the issues investigated there are feelings of sadness, failure, dissatisfaction, pessimism, self-judgment, distorted body vision, tiredness, lack of appetite, constant concerns, difficulty in work activities, and loss of libido (ANDRADE et al., 2020).
Time frame: Zero week, six week, and twelve week
Physical activity level
The participants' physical activity levels will be measured using the International Physical Activity Questionnaire - IPAQ-C, in its short version, including eight self-administered questions, in different domains such as work, leisure, domestic activities, and physical exercise. The data expressed in minutes, with the metabolic equivalent calculated (1 MET: 3.5 ml/kg/min). As with other questionnaires, we will apply it in electronic format, already tested and proven by previous studies (PIRES et al., 2014). Proposed and validated by the World Health Organization in 1998, it had its Brazilian version in 2001, through the study by Pardini et al. (PARDINIA et al., 2001).
Time frame: Zero week, six week, and twelve week
Functionality / Flexibility
Flexiteste is a tool developed by Araújo and Pavel in 1986 to analyze the flexibility of twenty articular movements of the human body (SALVADOR et al., 2010). Passively performed, with the examiner's aid up to the maximum joint amplitude, will adapt it for the online format, done in an active-assisted way, where the examined person assists the top angle, with the help of the opposite upper limb, with scores from 0 to 4. Higher values indicate increased mobility (ARAÚJO, 1986). The investigator masked will guide the patient's position remotely throughout the test.
Time frame: Zero week, six week, and twelve week
Painful intensity at rest and movement
Pain intensity will be analyzed using the Visual Analog Pain Scale - VAS, which comprises values from 0 to 10, where 0 corresponds to "no pain" and 10 "means the greatest pain imaginable" (HERNÁNDEZ et al., 2019). Being a unidirectional scale allows measuring the pain felt at the test's exact moment (MARTINEZ et al., 2011). The project will be used to check the pain at rest and right after the execution of a movement, aiming to understand the pain behavior before the proposed activity, in three moments: week 0, week six, and week 13. The associated test will elevate the upper limbs, with the hands splayed upwards and the fingers intertwined, using three sustained series of ten seconds, to be performed, together with the examiner's online presence. The EVA will be shown to the participant before the exercise and immediately after.
Time frame: Zero week, six week, and twelve week
Subjective perception of well-being
Will analyze the subjective perception of well-being through a simple question, "in your opinion, how much did participation in the project improve your feeling of general well-being," with structured responses based on the 5-point Likert Scale, varying from "dissatisfied" to "very satisfied." The same will be applied to the two groups in the same format as the questionnaires previously mentioned, through Google Docs, with a link to be made available on a scheduled date and time, through the WhatsApp application.
Time frame: Twelve week
Plan to share: No
Ran from Jan 2021 to primary completion in Jan 2022, 11 months.
Of 436 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's 11 months is below that.
Counting every sponsor, half of 449 studies reached it within 15 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Federal University of Pelotas