Second episode of “Vozes do Clima” discusses the impacts of the climate emergency in quilombola territories
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This week, the Instituto Socioambiental (ISA) released the second episode of “Vozes do Clima”, audio bulletin launched on June 6th with the aim of providing information to indigenous and quilombola peoples and traditional communities on topics related to the climate issue
quilombola leaders address the impacts of the climate emergency in their territories and suggest actions to face the problem.
The coverage was carried out during the 2nd Aquilombar, the biggest event of the Brazilian quilombola movement, held by the National Coordination of Articulation of Black Rural Quilombola Communities (Conaq) on May 16th, with the theme “Ancestralizing the future”. During the meeting, which culminated in a large march with more than 3 thousand people
ISA heard leaders from various regions of the country who expressed concern about the future of traditional communities in the face of recurring environmental catastrophes
such as the most recent one that occurred in Rio Grande do Sul
which left 136 quilombola communities in a state of calamity or in an emergency situation
according to data from the Ministry of Racial Equality.
“We are very sorry about the situation that Rio Grande do Sul has been going through
Communities (quilombolas) are being devastated by this climate catastrophe
We had a large delegation from Rio Grande do Sul to be here
but they were unable to arrive due to this situation”
member of the Divino Espírito Santo quilombo
told ISA how climate change interferes with the cultivation and production of food
the main source of income for many communities
Then there’s a terrible drought and the farmer loses his beans completely
because it didn’t rain.” This is climate change,” she stressed
the National Congress responded to the catastrophe faced by the people of Rio Grande do Sul and to many others that have already occurred in the country.
“The approved project defined that there must be civil society participation in the various stages of these plans
These reviews must take place every four years due to the advance of the climate emergency”
only 11 have a climate adaptation plan and several reasons are presented as challenges for them to be expanded
such as the lack of resources and guidelines on how to include civil society in this discussion
these guidelines will be clarified and financing mechanisms will also come into existence”
The slowness of the recognition and titling processes for quilombola territories is also a concern for those interviewed in the episode. Shortly before Aquilombar happened, the federal government had informed the movement's leaders that it would deliver documentation of the definitive title of their territories during the event, which ended up not being confirmed
This delay is also reflected in the various threats faced by communities. Even though they are among the most preserved areas in Brazil, 98,2% of quilombola territories are threatened by infrastructure works, mining requirements and overlapping private properties, according to a study by ISA in partnership with Conaq.
“ISA research with Conaq shows that the titled territories are the ones that have preserved the most
Because these territories are more protected and the land grabber or the process of deforestation
is more contained because that territory is titled”
explained that many quilombola territories are pressured by these three vectors
many rural environmental records and areas of influence of infrastructure works within the same territory
increasing the degree of vulnerability of these territories”
Even though Brazil is a signatory to Convention 169 of the International Labor Organization (ILO)
many projects are carried out without this right being guaranteed to indigenous peoples
quilombolas and other traditional communities
prior and informed consultation with traditional populations
in the case of the implementation of any public policy
or project that affects the lives of these people
And what we realize is that infrastructure works in Brazil do not carry out adequate consultation with residents
The “Vozes do Clima” audio bulletin is produced by ISA, produced by the podcast producer Bamm Mídia and supported by Environmental Defense Fund (EDF)
The visual identity was designed by indigenous designers and illustrators Kath Matos and Wanessa Ribeiro
In addition to being distributed via Whatsapp and Telegram
the program can also be heard on the audio platforms Spotify
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Insulin resistance (IR) is defined as the subnormal response to insulin action on its target tissues
Studies suggest that IR may increase the risk of hypertension
but the results are inconsistent and it is not known whether such an effect is independent of overweight/obesity
We aimed to evaluate the association between IR and the incidence of prehypertension and hypertension in the Brazilian population and whether this association is independent of overweight/obesity
In 4717 participants of the Brazilian Longitudinal Study of Adult’s Health (ELSA-Brasil)
free of diabetes and cardiovascular disease at baseline (2008–2010)
we investigated the incidence of prehypertension and hypertension after a mean follow-up of 3.8 ± 0.5 years
Insulin resistance at baseline was assessed by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) index
The risk of IR-associated prehypertension/hypertension was estimated by multinomial logistic regression after adjustment for confounding factors
Secondary analysis were stratified by body mass index
The mean (SD) age of participants was 48 (8) years
The 75th percentile of HOMA-IR at baseline was 2.85
The presence of IR increased the chance of developing prehypertension by 51% (95% CI 1.28–1.79) and hypertension by 150% (95% CI 1.48–4.23)
the presence of IR remained associated with the incidence of prehypertension (OR 1.41; 95% CI 1.01–1.98) and hypertension (OR 3.15; 95% CI 1.27–7.81)
our results suggest that IR is a risk factor for hypertension
regardless of the presence of overweight or obesity
we did not identify multicenter cohorts carried out in Latin American population that have studied the impact of IR in individuals without diabetes on the development of prehypertension and hypertension
ELSA-Brasil procedures were approved by the National Research Ethics Committee (CONEP/MS 976/2006) and by Research Ethics Committees of Universidade Federal da Bahia
Universidade de São Paulo e Universidade Federal do Rio Grande do Sul
All methods were performed in accordance with the relevant guidelines and regulations
Informed consent was obtained from all subjects
validated in Brazil and was analyzed stratified into categories of low
Descriptive analyses were presented as mean (standard deviation) or median (interquartile range)
Categorical variables were described as frequencies and percentages
Group comparisons were made using Kruskal–Wallis or ANOVA tests for continuous variables and the Chi-square test for categorical variables
For incidence of prehypertension and hypertension
IR at baseline was considered as the exposure factor and incident prehypertension and hypertension at the second assessment of ELSA-Brasil was considered the outcome
We did not adjust by baseline pressure values because we already excluded all those with higher baseline pressure levels (with prehypertension) from our sample
We understand that this strategy greatly reduces the effect of eventually higher basal pressure levels
with the same other covariates used for adjustments
The results were presented as Odds Ratio (OR) considering a 95% confidence interval (CI)
Sociodemographic data and clinical characteristics collected at baseline are shown in Supplement 1
Participants had a mean (SD) age of 48 (7.9) years
67% were women and 63% had higher education
The median (IIq) value of HOMA-IR was 1.97 (1.37–2.85) and IR was present in 1179 participants (HOMA-IR > 2.85)
More than 95% of the patients in our sample had creatinine clearance above 60 mL/min
thirty six percent of the participants were overweight and 11% obese (data not shown)
Table 1 shows participants’ characteristics stratified by the presence of incident prehypertension or hypertension
Impact of insulin resistance in the incidence of prehypertension and hypertension stratified by body mass index
including 4717 Brazilian adults free of diabetes and CVD
we showed that IR increased the risk of developing prehypertension by 51% and hypertension by 150% after 3.8 ± 0.5 years of follow-up
IR was able to predict the incidence of prehypertension and hypertension in individuals with normal BMI
revealing that it is a risk factor independent of overweight or obesity
Given the importance of prehypertension as an independent cardiovascular risk factor
in this study we considered prehypertension as an outcome
showed an increased risk for hypertension even when only normotensive individuals were included at baseline
suggesting that IR contributes to blood pressure elevation across the continuum and not only in those at higher risk of becoming hypertensive because they already have higher baseline blood pressure levels
both of which are important in the pathophysiology of hypertension
IR acted as a risk factor for the development of hypertension and pre-hypertension in Brazilian adults free of diabetes
As the ELSA-Brasil follow-up time advances
it will be possible to further investigate how IR affects the acceleration in SBP and DBP over the years
The datasets used and/or analysed during the current study available from the corresponding author on reasonable request
Freeman, A. M., & Pennings, N. Insulin Resistance [Internet]. Em: StatPearls. Treasure Island (FL): StatPearls Publishing; 2020. Available from: http://www.ncbi.nlm.nih.gov/books/NBK507839/
insulin resistance and risk of hypertension in the general population: A meta-analysis
Hyperinsulinemia and homeostasis model assessment of insulin resistance as predictors of hypertension: A 5-year follow-up study of Korean sample
Hypertension and diabetes mellitus: Coprediction and time trajectories
Interplay of overweight and insulin resistance on hypertension development
Influence of insulin resistance and body mass index at age 13 on systolic blood pressure
and high-density lipoprotein cholesterol at age 19
Insulin resistance and hypertension: The Insulin Resistance Atherosclerosis study
Predictors of incident hypertension in healthy non-diabetic postmenopausal women with normal renal function
Srivastava A, Sharan S. Prehypertension [Internet]. Em: StatPearls. Treasure Island (FL): StatPearls Publishing; 2020. Available from: http://www.ncbi.nlm.nih.gov/books/NBK538313/
Prehypertension and cardiovascular disease risk in the Women’s Health Initiative
Associations of insulin resistance with systolic and diastolic blood pressure: A study from the HCHS/SOL
Brazilian longitudinal study of adult health (ELSA-Brasil): Objectives and design
Cohort profile: Longitudinal study of adult health (ELSA-Brasil)
ELSA-Brasil strategies for outcome identification
Recrutamento de participantes no Estudo Longitudinal de Saúde do Adulto
Questionário do ELSA-Brasil: Desafios na elaboração de instrumento multidimensional
Aferições e exames clínicos realizados nos participantes do ELSA-Brasil
Logistics of collection and transportation of biological samples and the organization of the central laboratory in the ELSA-Brasil
Rotinas de organização de exames e entrevistas no centro de investigação ELSA-Brasil
Electrocardiographic findings in Brazilian adults without heart disease: ELSA-Brasil
Diagnosing insulin resistance by simple quantitative methods in subjects with normal glucose metabolism
Homeostasis model assessment closely mirrors the glucose clamp technique in the assessment of insulin sensitivity: Studies in subjects with various degrees of glucose tolerance and insulin sensitivity
Evaluation of surrogate measures of insulin sensitivity—Correlation with gold standard is not enough
Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man
Questionário internacional de atividade física (IPAQ): Estudo de validade e reprodutibilidade no Brasil
Impact of high-normal blood pressure on the risk of cardiovascular disease
and incident hypertension in the multi-ethnic study of atherosclerosis
Role of hyperinsulinemia and insulin resistance in hypertension: Metabolic syndrome revisited
Non-insulin-dependent diabetes mellitus and fasting glucose and insulin concentrations are associated with arterial stiffness indexes
The state of hypertension care in 44 low-income and middle-income countries: A cross-sectional study of nationally representative individual-level data from 1·1 million adults
Correlation between hypertension and income distribution among United Arab Emirates population
Optimal cut-off values for the homeostasis model assessment of insulin resistance (HOMA-IR) and pre-diabetes screening: Developments in research and prospects for the future
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Coordenação de Aperfeiçoamento de Pessoal de Nivel Superior – Capes (Coordination for the Improvement of Higher Education Personnel)
Conselho Nacional de Desenvolvimento Científico e Tecnológico – CNPQ (National Council for Scientific and Technological Development)
Fundação de Amparo a Pesquisa do Estado de Minas Gerais (FAPEMIG) (Foundation for Research Support of the State of Minas Gerais)
Ribeiro is supported in part by CNPq (310679/2016-8 and 465518/2014-1) and by FAPEMIG (PPM-00428-17 and RED-00081-16)
Griep is supported in part by CNPq (404168/2020-5)
Longitudinal Study of Adult Health - ELSA Brasil
Sandhi Maria Barreto & Antonio Luiz Ribeiro
Center for Clinical and Epidemiological Research
Paulo Lotufo & Isabela Judith Bensenor
Laboratory of Education in Environment and Health
A.L.P.R.: designed the study and did the statistical analyzes
wrote the main manuscript and prepared figures/tables
The authors declare no competing interests
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations
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DOI: https://doi.org/10.1038/s41598-023-35298-y
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Low back pain (LBP) is the most frequent complaint in clinical practice
Electroacupuncture treatment may be effective; however
The current study is a randomized controlled trial that aims to evaluate the clinical efficacy of electroacupuncture in older adults with LBP
A five-arm randomized controlled trial with patients and evaluators blinded to the group allocation
A total of 125 participants with non-specific LBP will be randomly assigned into one of five groups: three electroacupuncture groups (low
and alternating frequency); one control group; and one placebo group
The electroacupuncture will be applied twice a week (30 min per session) for five weeks
The primary clinical outcome measure will be pain intensity
The secondary outcomes include: quality of pain; physical functioning; perceived overall effect; emotional functionality; patient satisfaction; and psychosocial factors
Patients will be evaluated before the first session
and followed up after six and 12 months to check the medium- and long-term effects
Although electroacupuncture is increasingly used to treat LBP
there is no guidance regarding the parameters used
the effect of electroacupuncture (EA) on LBP remains controversial and requires more studies
This is the first randomized controlled trial to evaluate the efficacy of different frequencies of electroacupuncture for treating chronic LBP in older adults
This study will provide evidence on the effectiveness of electroacupuncture as an alternative treatment method for LBP and will entail wider debate about an appropriate acupuncture intervention in this population
Clinicaltrials.gov, NCT03802045
Considering the prevalence of LBP in older people, the significance of health problems associated with this painful condition, and the lack of evidence in acupuncture guidelines, a thorough designed randomized controlled clinical trial is proposed.
This study aims to evaluate the clinical efficacy of EA in older adults with LBP.
Our primary study goal is to screen a dominant EA frequency on pain management and its secondary outcomes in EA groups.
Our second goal is to determine whether EA is a more effective treatment than acupuncture (control) and placebo in older people with chronic LBP, in a one-year randomized controlled trial (RCT) (NCT03802045).
Our third goal is to determine the long-term effect of the EA, acupuncture, and placebo on LBP in older adults after six months and one year at the end of treatment.
This study is a five-arm clinical RCT with blinded patients and evaluators.
The study will be conducted at the University of São Paulo (USP) in partnership with the Federal University of Paraná (UFPR), both in Brazil. The study was approved by the Research Ethics Committee of the Medical School of USP (authorization no. 2.903.991) and financed with the authors’ own resources.
Participants will be recruited through radio ads, social networks, and local newspapers. Individuals will be informed about the research proposal and treatment protocol, and those interested in participating will be selected according to the inclusion and exclusion criteria.
We will use the World Health Organization (WHO) cut-off point of ≥ 60 years to refer to the elderly population in resource-poor countries [9]
Other criteria are: (1) medical diagnosis of non-specific LBP of > 3 months’ duration; (2) with or without radiating leg pain; (3) a minimum pain intensity score of 4 on the 11-point pain numerical rating scale (NRS; Brazilian Portuguese version); (4) walk independently (with or without walking devices); and (5) signing of the consent form
Patients will be excluded if: (1) they have had previous surgery on the spinal column; (2) have a known or suspected serious spinal pathology (e.g
or cauda equina syndrome); (3) fear of needles; (4) have participated in acupuncture treatment in the previous 30 days; or (5) if they are wheelchair users
Patients will remain blinded regarding the category of their allocation throughout the study data collection period
the evaluators responsible for the data collection and the outcomes assessor will also be blinded to the patient allocation
The acupuncturist responsible for the interventions will be the only person not blind to the type of treatment to be performed
The interventions will be performed by acupuncture specialists with at least three years of clinical experience
who will receive prior training to ensure that they rigorously follow the study protocol and are familiar with the types of treatments
including details such as acupuncture points and manipulation of electroacupuncture parameters
Four stages of evaluations will be performed: (1) before the start of treatment; (2) immediately after the end of treatment (five weeks); (3) at six months; and (4) one year after the final treatment
This measure will be assessed through the Roland Morris Disability Questionnaire (RMQ) and the Five Times Sit to Stand Test (FTSST)
This contains 24 items pertaining to activities that can be impaired due to LBP
Individuals need to select the items that apply to their pain on that day
The selected items are summed for a total score ranging from 0 to 24
with higher scores indicating more severe functional incapacity
The patient initiates the FTSST sitting in a chair without arm support
with the upper limbs crossed over the chest
feet positioned at hip width and knees in 90° flexion
They will be asked to stand and sit five times as fast as possible
A timer will be used to measure the task execution time
The test will be performed twice and the mean time will be calculated
The BDI is a self-administered questionnaire that contains 21 items
where a higher score indicates more depressive symptoms
where the left extremity is related to the absence of anxiety and the right extremity is related to the worst possible anxiety
The individual is asked to assess the intensity of their anxiety in the previous 24 h and to mark this on the line
The distance from the left edge of the line to the mark placed by the patient is measured in millimeters
Greater measurements indicate greater anxiety
covering global aspects of the treatment (two items)
aspects related to the service provided (eight items)
and aspects about the therapist–patient relationship (10 items)
the patient’s response will range from 1 (strongly disagree) to 5 (strongly agree)
where higher scores represent greater satisfaction with the treatment
and AF groups will be submitted to the treatment protocol
which will consist of the bilateral application of electroacupuncture using a previously calibrated electrostimulator (Sikuro DS100C)
consisted of alternating symmetrical biphasic waves with continuous pulse train for the low (2 Hz) or high (100 Hz) frequency groups
and a mixed pulse train for the alternating frequency group (100 Hz and 2 Hz for 3 s each); 100 ms pulse duration and 0.5 ms pulse width; and the maximum current (amplitude) intensity tolerated by the patient and intensified so that sensory habituation is avoided
Trichotomy will be carried out when necessary and the skin will be disinfected with 70% alcohol
With the participant lying down in a ventral position
the needles will be inserted at a 90° inclination with the skin
to a depth at which that the patient reports the “deQi” sensation (≅ 1.5 cm)
The protocol sessions will happen twice a week (30 min per session) for five weeks
they only will be enlightened about the control and placebo group when they finish the 12-month follow-up evaluation
each one of them will be asked to answer the questions: “Did you feel the needle penetrate your skin?” and “Did you feel that you received real electroacupuncture?”
if we observe that the therapeutic effect of one group (EA treatment or control) will statistically greater than the placebo group
we will ensure that all participants of this group receive the best treatment when they finish the 12-month follow-up evaluation
the participants will be asked about any unpleasant and unintended signs or symptoms associated with the use of electroacupuncture
A questionnaire will also be used with a record of the duration and intensity of the adverse symptom reported by the patient
which will be scored according to a Likert-type scale of 1–5
with 1 representing the absence of adverse symptoms and 5 severe adverse symptoms
The severe adverse symptoms will exclude the participant from the treatment and the participant will be referred for medical consultation
Participants may withdraw from the study for any reason at any time
All dropouts and attrition during the course of the study will be monitored and the respective reasons for withdrawal will be recorded
All randomized participants will be included in the analysis independent of whether they complete the intervention or not (intention-to-treat principles)
a statistical power of 80% (1 β error probability)
an extra 20% of participants will be added in order to increase the power
this study will therefore require a total of 125 participants
The analysis of the data will follow the intention-to-treat principles
The normality of the data distribution will be assessed by the Kolmogorov–Smirnov test
The Pearson test will be used for correlations between variables that present a normal distribution
and the Spearman test will be adopted for correlations between variables that present a non-normal distribution
All the analyses will be carried out using the SPSS program (IBM Corp.
The confidence interval will be established at 95%
and the significance level will be set at 5%
All the patients will participate voluntarily and will sign a consent form before randomization
The access and storage of the data will be in accordance with the guidelines of the National Research Ethics Commission (CONEP)
This study has been approved by the Ethics Committee of the University of São Paulo Medical School (authorization No
2.903.991) and in ClinicalTrials.gov under number NCT03802045
independent ethics committee (IEC)/Institutional Review Board (IRB) review and regulatory inspection(s)
Local investigators will provide direct access to the source data documents
This protocol has been written in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. The SPIRIT checklist is in Additional file 1
with no guidance regarding the parameters used
the effect of EA on LBP remains controversial and requires more studies
who are the leading population for this painful condition
and well-delineated clinical trials in order to standardize EA treatment in LPB and to improve the level of scientific evidence
Here we describe the protocol for a clinical RCT to investigate the efficacy of different frequencies of EA for the treatment of older adults with chronic LBP
and thus to determine the most effective EA frequency
We expect that the results of this study will aid in the standardization of the technique and provide convincing experimental evidence of the efficacy of EA treatment in older people with LBP
Our study presents the non-blindness of the practitioner as a limitation
since it is not possible to blind the acupuncturist to the type of treatment
This trial number NCT03802045 is currently in the recruitment phase
The date recruitment started was April 2019 and the expected date for recruitment completion is October 2019
All data generated or analyzed in this study will be fully available without restriction through online platform on Clinicaltrials.gov (NCT03802045)
Ethics Committee of the School of Medicine of the University of Sao Paulo
Visual analog scale for the assessment of anxiety
Statistical Package for the Social Sciences
Revised Standards for Reporting Interventions in Clinical Trials of Acupuncture
Factors associated with chronic back pain in adults in Brazil
Older adult’s experience of chronic low back pain and its implications on their daily life: Study protocol of a systematic review of qualitative research
Low back pain in older adults: risk factors
Predictors of disability and absenteeism in workers with non-specific low back pain: A longitudinal 15-month study
Effect of Electroacupuncture on the NTS is modulated primarily by acupuncture point selection and stimulation frequency in normal rats
Manual and electrical needle stimulation in acupuncture research: pitfalls and challenges of heterogeneity
Efficacy of acupuncture and electroacupuncture in patients with nonspecific low back pain: study protocol for a randomized controlled trial
Clinical practice guidelines of using acupuncture for low back pain
Single or Multiple Electroacupuncture Sessions in Nonspecific Low Back Pain: Are We Low-Responders to Electroacupuncture
DeSantana JM: Does electroacupuncture treatment reduce pain and change quantitative sensory testing responses in patients with chronic nonspecific low back pain
Core outcome measures for chronic pain clinical trials: IMMPACT recommendations
adaptation and validation of the Roland-Morris questionnaire--Brazil Roland-Morris
Validation of the Brazilian Portuguese version of the Beck Depression Inventory-II in a community sample
Measurement properties of the Brazilian Portuguese version of the MedRisk instrument for measuring patient satisfaction with physical therapy care
The Brazilian version of STarT Back Screening Tool - translation
Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best
Effects of the carrier frequency of interferential current on pain modulation in patients with chronic nonspecific low back pain: a protocol of a randomised controlled trial
Adapted version of the McGill Pain Questionnaire to Brazilian Portuguese
The Brazilian-Portuguese versions of the McGill Pain Questionnaire were reproducible
and responsive in patients with musculoskeletal pain
Assessment of sit-to-stand movement in nonspecific low back pain: a comparison study for psychometric properties of field-based and laboratory-based methods
Psychometric properties of the Portuguese version of the Beck Depression Inventory on Brazilian college students
Psychometric evaluation of a visual analog scale for the assessment of anxiety
Acupuncture for chronic low back pain: a randomized controlled feasibility trial comparing treatment session numbers
Chronic nonspecific low back pain: rehabilitation
The effect of brief electrical and manual acupuncture stimulation on mechanical experimental pain
Clinical research from the perspective of integrity
Effects of the carrier frequency of interferential current on pain modulation and central hypersensitivity in people with chronic nonspecific low back pain: A randomized placebo-controlled trial
Acupuncture for musculoskeletal pain: A meta-analysis and metaregression of sham-controlled randomized clinical trials
Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview
Acupuncture for chronic pain: an update and critical overview
Management of chronic pain using complementary and integrative medicine
acupressure and chiropractic interventions on treatment of chronic nonspecific low back pain in Iran: A systematic review and metaanalysis
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The authors would like to acknowledge the support and contribution of their partner organization (Federal University of Parana) to the study
The authors also thank the contributions of the older adult patients with LBP who will participate in this trial
The authors received no financial support for the research
Postgraduate Program in Rehabilitation Sciences
Priscila de Oliveira Januário & Amélia Pasqual Marques
Department of Physical Therapy Prevention and Rehabilitation
Higher Education Unit of the South of Maranhao
SFT helped to conceive and design the trial
ACBM contributed to the design and implementation of the study
MDA wrote the first draft and also contributed to the design and implementation of the study
IMBS also wrote the first draft of this article and contributed to finalizing the manuscript
FDRPS planned the statistical analysis and contributed to finalizing the manuscript
ASES wrote the second draft of this article
FRJ designed the electroacupuncture protocol in the study and contributed to finalizing the manuscript
ATC she contributed to the methodology and discussion of the study
POJ also contributed to the design of the study and contributed to finalizing the manuscript
She provided valuable feedback throughout the writing of this manuscript
All authors contributed to refinement of the study protocol and approved the final manuscript
This study was approved by the Ethics Committee of the School of Medicine of the University of Sao Paulo in September 2018 (authorization no
The project coordinators will provide participants with written and oral information about the study before enrolment
All participants will sign informed consent before enrolment in the study
All authors deny any financial and personal relationships with other people or organizations that could inappropriately influence this work
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DOI: https://doi.org/10.1186/s13063-019-3813-6
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