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Physiotherapy Theory and Practice
An International Journal of Physical Therapy
ISSN: 0959-3985 (Print) 1532-5040 (Online) Journal homepage: https://www.tandfonline.com/loi/iptp20
Effects of aquatic physiotherapy or health
education program in women with fibromyalgia: a
randomized clinical trial
Angélica Cristina Sousa Fonseca, Priscila Conceição Faria, Marcus
Alessandro De Alcântara, Wálisson Dias Pinto, Letícia Gontijo De Carvalho,
Filipe Gustavo Lopes & Andrei Pereira Pernambuco
To cite this article: Angélica Cristina Sousa Fonseca, Priscila Conceição Faria, Marcus
Alessandro De Alcântara, Wálisson Dias Pinto, Letícia Gontijo De Carvalho, Filipe Gustavo Lopes
& Andrei Pereira Pernambuco (2019): Effects of aquatic physiotherapy or health education program
in women with fibromyalgia: a randomized clinical trial, Physiotherapy Theory and Practice, DOI:
10.1080/09593985.2019.1639229
To link to this article: https://doi.org/10.1080/09593985.2019.1639229
Published online: 15 Jul 2019.
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Effects of aquatic physiotherapy or health education program in women with
fibromyalgia: a randomized clinical trial
Angélica Cristina Sousa Fonseca, PTa, Priscila Conceição Faria, PTa, Marcus Alessandro De Alcântara, PhD, PTb,
Wálisson Dias Pintoa, Letícia Gontijo De Carvalhoa, Filipe Gustavo Lopes, MScb,c, and Andrei Pereira Pernambuco,
PhD, PTa,d
aDepartment of physiotherapy , Centro Universitário de Formiga – MG (UNIFOR-MG), Formiga, Minas Gerais, Brasil; bUniversidade Federal
dos Vales do Jequitinhonha e Mucuri (UFVJM), Diamantina, Minas Gerais, Brasil; cPrograma de Neurorreabilitação em Lesão Medular da Rede
SARAH de Hospitais de Reabilitação, Belo Horizonte, Minas Gerais, Brasil; dDepartment of physiotherapy, Universidade de Itaúna – MG (UIT),
Itaúna, Minas Gerais, Brasil
ABSTRACT
Background: Different treatments have been proposed for Fibromyalgia, but only few studies
have compared their effects on multiples outcomes over time. Objective: The objective of this
study was to investigate the effects of aquatic physiotherapy (AP) or a health education program
(HEP) in a sample of women with Fibromyalgia (FM). Methods: Forty-six women with FM, aged
between 25 and 60 years old, whose BMI was less than 30, were assigned to either AP (27 women)
or HEP (19 women) groups in a blind randomized clinical trial lasting eleven weeks. Pain (McGill
Pain questionnaire), fatigue (Piper Fatigue Scale-Revised), functional capability (Fibromyalgia
Impact questionnaire), anxiety (Beck Anxiety Inventory), depression (Beck Depression Inventory)
and quality of sleep (Pittsburgh Sleep Quality Index) data were collected at baseline, after six
weeks and post intervention. Two-factor mixed-model analysis of variance (ANOVAs) were used to
examine the effects of the treatment on each outcome variable. Results: The AP and HEP
interventions showed statistically significant within-group differences on all outcome measures
except reducing the pain. Between-group differences was statistically significant only for impact
of FM on the participant’s life [F(1.82,80.41) = 31,99; p ≤ 0.01] indicating that patients receiving HEP
experienced a greater decrease in FIQ than those treated with AP. Conclusion: The findings do
not allow to affirm that one intervention is superior to the other for the treatment of people with
FM. Future studies should investigate whether the combination of HEP and PA can be effective
and long-lasting.
ARTICLE HISTORY
Received 8 March 2018
Revised 5 April 2019
Accepted 28 May 2019
KEYWORDS
Fibromyalgia; health
education; aquatic
physiotherapy; treatment
Introduction
Fibromyalgia (FM) is a clinical condition characterized by
the occurrence of chronic and generalized pain, associated
with other symptoms and comorbidities such as fatigue,
depression, anxiety and sleep disorders (Sarzi-Puttini et al.,
2012a). This condition primarily affects women, in
a proportion of nine women for each man (Hauser,
Bialas, Welsch, and Wolfe, 2015). The pathophysiology
of FM has not been fully elucidated yet, however, the
available evidence suggest a complex interaction between
multiple factors, such as immunological, neuroendocrine,
behavioral, genetics, among others (Carvalho et al., 2008;
Sarzi-Puttini, Atzeni, and Perrot, 2012b; Uceyler et al.,
2017). For some authors, an imbalance in the stress
response system, the hypothalamic-pituitary-adrenal axis
(HPA), would have an important role in the genesis and
evolution of FM symptoms (Carvalho et al., 2008;
Pernambuco, 2014; Pernambuco et al., 2017; Wingenfeld
et al., 2010). The limited understanding on the pathophy-
siological mechanisms and the clinical heterogeneity pre-
sented by the patients are factors that hinder the
development of effective therapeutic conducts (Mease
et al., 2007; Uceyler et al., 2017).
Ideal management of FM requires a patient-tailored,
multimodal approach based on both pharmacological
and non-pharmacological interventions (Fitzcharles
et al., 2013; Kia and Choy, 2017). Regarding pharma-
cological treatment, the evidence supports the use of
Amitriptyline, Duloxetine, Pregabalin, Tramadol
Hydrochloride, Minalcipran and Fluoxetine (Kia and
Choy, 2017). Pharmacological management should
consider each patient individuality, adverse effects,
and drug interaction. The drug interaction, although
Corresponsing Author: Andrei Pereira Pernambuco pernambucoap@ymail.com Centro Universitário de Formiga – MG (UNIFOR-MG), Avenida
Dr. Arnaldo de Senna 328 – Água Vermelha, Formiga, Minas Gerais, Brasil
Color versions of one or more of the figures in the article can be found online at www.tandfonline.com/iptp.
PHYSIOTHERAPY THEORY AND PRACTICE
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it does not find support in the current literature, is
frequently used by patients with FM (Fitzcharles et al.,
2013; Kia and Choy, 2017).
Concerning non-pharmacological conducts, the most
used treatments are: acupuncture, physiotherapy, cogni-
tive behavioral therapy, a number of manual therapies,
aquatic physiotherapy (AP), health education programs
(HEP), and others (Fitzcharles et al., 2013; Mease et al.,
2007; Souza, Bourgault, Charest, and Marchand, 2008).
Regardless of the non-pharmacological alternative used, it
is necessary to consider the patient’s preferences and
abilities. In addition, patients should be encouraged to
be self-sufficient, to develop good coping strategies, and
to lead a life as close to normal as possible. (Fitzcharles
et al., 2013). In this sense, AP and HEP emerge as impor-
tant non-pharmacological alternatives, mainly because
they present a better cost-effective option (Ade, Paula,
Diniz, and Almeida, 2011; Souza, Bourgault, Charest,
and Marchand, 2008).
AP consists of exercises performed in a pool with
heated water between 32ºC and 33ºC (89,6°F and 91,4°F)
(Salvador, Dias, and Zirbes, 2005). In people with FM
these exercises are performed aiming at relieving the
symptoms that make up the clinical picture of this condi-
tion (Perraton, Machotka, and Kumar,2009; Trevisan
et al., 2015). During AP it is possible to produce benefits
such as: muscle strengthening, reduction of muscle
spasms, muscle relaxation, increase of blood circulation
and self-esteem improvement (Bagdatli et al., 2015). Such
benefits were demonstrated in a meta-analysis, which
evaluated the efficacy of AP in people with FM in con-
trolled clinical trials (Lima et al., 2013).
The HEP is defined as a planned learning combina-
tion based on experiences that are verbally transmitted
to individuals (Gold and Miner, 2001; Pernambuco
et al., 2018). In 2008, a specific HEP was developed
for people with FM. This program was denominated
Inter-relational School of Fibromyalgia (ISF) (Souza,
Bourgault, Charest, and Marchand, 2008). It consisted
of a multidisciplinary approach that aims at increasing
the patients’ knowledge about FM and the conse-
quences resulting from this condition. The ISF can
help the participants better cope with their clinical
condition by encouraging certain positive attitudes.
The study mentioned demonstrated a significant
improvement in the clinical status of the women with
FM who participated in the ISF for 11 weeks. The
results included improvement in pain, perception of
life control and the impact caused by FM in everyday
activities (Souza, Bourgault, Charest, and Marchand,
2008). Previous studies performed by this research
group have shown that ISF significantly contributed
not only to patients’ subjective perception of their
health (Fonseca, Faria, and Pernambuco, 2016;
Pernambuco et al., 2018; Souza, Bourgault, Charest,
and Marchand, 2008), but also to the improvement of
the levels of neuroendocrine and immunological mar-
kers in people with FM (Pernambuco et al., 2018).
However, despite the benefits provided by both AP
and HEP such as ISF, no study has compared the effects
of these two treatment methods in people with FM until
now. Thus, the objective of this study was to evaluate
and compare the effects of two non-pharmacological
treatments (AP and HEP) on multiple outcomes related
to the symptoms and comorbidities presented by indi-
viduals with FM.
Methods
This was a randomized, blinded clinical trial. The steps of
the study were initiated after the approval of the research
protocol by the Human Research Ethics Committee of the
Centro Universitário de Formiga, under the register
687.895. The volunteers agreed to participate in the
research by signing two copies of an informed consent
form one copy for the researchers and one for the parti-
cipant. All ethical care was guided by the recommenda-
tions of the Resolution 466/12 of the Declaration of
Helsinki. The research protocol was approved by the
Registro Brasileiro de Ensaios Clínicos (ReBEC) Clinical
Trials Registry Number (ReBEC- RBR-7zxk77).
Participants
Participant recruitment was done through advertisements
on the local radio, printed in newspapers and posters
displayed in health units of Formiga. No preplanned sam-
ple size calculation was made. All potential patients were
submitted to clinical evaluation by a physician to confirm
the FM diagnosis according to the 2011’s American
College of Rheumatology (ACR) criteria (Wolfe et al.,
2011). The following women were included in this study:
confirmed FM diagnosis, aged between 25 and 60 years
old, Body Mass Index (BMI) below 30 Kg/cm2, fluent in
Portuguese and those who signed a written informed con-
sent. BMI below 30 kg/cm2 was placed as inclusion criter-
ion to avoid biases related to the participant’s weight, since
obesity may cause functional limitations capable of inter-
feringwith the results of this study (Kim et al., 2012). Study
participants should continue to use the previously pre-
scribed medication.
The following women were not included in this
study: illiterate; not confirmed the FM diagnosis; past
or present chronic inflammatory disease (i.e. spondy-
loarthritis and ankylosing spondylitis); or autoimmune
diseases (i.e. systemic lupus erythematosus or
2 A. C. S. FONSECA ET AL.
rheumatoid arthritis); past or present psychiatric dis-
eases (i.e. major depression, schizophrenia, and bipolar
disorder); acute infectious disease at the time of data
collection; using anti-allergic, antibiotics or anti-
inflammatory drugs in the last three months; pregnant
or breastfeeding; and lack of pharmacological stability
for a period of at least three months before the begin-
ning of the randomization. After the start of the inter-
vention, the following women were excluded: those
who had less than 80% frequency, those who felt bad
during the proposed activities, those who became preg-
nant, and those who changed medications (i.e. switch-
ing or discontinuing drugs and or modifying the
prescribed dosage) during the study period
(Pernambuco et al., 2018). It is important to mention
that the use of prescribed medication could result in
performance bias, but for clinical and ethical reasons
the suspension of the prescribed medication was not
allowed. The use of another non-pharmacological treat-
ment was not allowed during the study.
Randomization
To perform the randomization, 100 numbered, opaque,
sealed envelopes were used and inside each one a paper
with a number from 1 to 100 was placed. This quantity
of envelopes was used because, on the day of the pre-
sentation of those interested in participating in the
research, no one knew how many volunteers would be
present. Therefore, the research team opted to over-
estimate the presence of the people with FM. At the
appointed time and date, the research team distributed
the envelopes to the volunteers. At that moment, not
even the researchers knew the contents of the envel-
opes, since all had been thoroughly scrambled. As pre-
viously stipulated, participants who received odd
numbers were allocated to the ISF group, and those
receiving even numbers were allocated to the AP
group. At the end the ISF group was composed of 19
participants and the AP group was composed of 27
participants (Figure 1). The imbalance of participants
between the groups was caused by the method of
Figure 1. CONSORT flowchart for non-pharmacologic interventions.
PHYSIOTHERAPY THEORY AND PRACTICE 3
randomization, since 100 sequential numbers were dis-
tributed to only 46 volunteers with FM. To preserve the
effects of randomization, intention-to-treat analysis
was performed, and the final analyses included the
data of the all 46 participants. All participants were
kept in the groups in which they had been originally
randomized.
Data collection
Seven questionnaires were administered by an indepen-
dent trained evaluator who was not part of the research
group. Before being referred for this study, the evalua-
tor participated in a pilot study to improve intra-rater
reliability (Fonseca, Faria, and Pernambuco, 2016). The
evaluator did not know the objectives of the study and
the intervention assigned for each participant. All data
were collected at three different stages: before the start
of treatment, after the sixth week of intervention and
immediately after the end of treatment. All the data
obtained by the independent evaluator through the
application of the questionnaires were sent to research-
ers. The following validated questionnaires were used
to collect data:
Pittsburgh sleep quality index
Questionnaire composed of 10 questions grouped into
7 components related to sleep quality. The maximum
score of this instrument is 21 points. Scores from 0 to 4
points indicate good sleep quality, from 5 to 10 points
indicate poor sleep quality and scores over 10 points
indicate sleep disturbance (Jimenez-Genchi et al.,
2008). According to a previous study, the Pittsburgh
Sleep Quality Index was a reliable and valid instrument
(r = 0.77, p ≤ 0.01) (adequate convergent validity ana-
lysis (p ≤ 0.01) with the FIQ total score and with the
mental and physical health summaries scores of the SF-
36) for measuring sleep quality among FM patients
(Hita-Contreras et al., 2014)
Beck depression inventory
An instrument composed of 21 items,which objective
is to evaluate the levels of depression. The sum of
individual scores provides a total. The following results
can be found: absence of depression or minimal depres-
sive symptoms (up to 9 points); mild to moderate
depressive symptoms (10 to 18 points); moderate to
severe depressive symptoms (19 to 29 points); and
severe depressive symptoms (63 points) (Gorenstein
and Andrade, 1996). The Beck Depression Inventory
presents with adequate clinimetrics properties for the
Brazilian population (good internal consistency –
Cronbach’s α = 0.82), and high discrimination of
depressive symptoms (75–100%) (Wang, Andrade,
and Gorenstein, 2005).
Beck anxiety inventory
Consisting of 21 objective questions, it is a questionnaire
used to measure the severity of anxiety. The statements
describe anxiety symptoms on a four-point scale (0 to 3).
The total score is the result of the sum of individual items
and allows the classification of anxiety levels. The maxi-
mum score is 63 points. Scores between 0 and 7 points
represent minimum degree of anxiety; scores between 8
and 15 points (mild anxiety); scores between 16 and 25
points (moderate anxiety); and scores between 26 and 63
points represent (severe anxiety) (Beck, Brown, Epstein,
and Steer, 1988). It was demonstrated that the Beck
Anxiety Inventory present adequate internal consistency
(ranged from 0.88 to 0.92) and discriminant validity (sen-
sitivity of 0.74 and specificity of 0.71 for a cut-off score of
10) (de Lima Osorio, Crippa, and Loureiro, 2011) and
adequate reliability (r = 0.84, p ≤ 0.01) (Vazquez Morejon,
Vazquez-Morejon Jimenez, and Zanin, 2014).
Piper fatigue scale-revised
Piper Fatigue Scale-Revised (PFS-R) consists of
a questionnaire which assesses the impact of fatigue on
the individuals in the exact moment of its application. It is
composed of 27 questions, though only 22 questions are
considered in the final scoring. Each of the questions should
be answered with a number which varies from 1 to 10, the
smaller numbers indicate strong disagreement on the state-
ment and the larger numbers indicate a strong agreement.
To obtain the final score, one should add the obtained
values in each of the 22 questions and in sequence, divide
the result by the number of questions, in this case 22. The
total score in PFS-Rmay vary from 0 to 10. The presence of
fatigue should be considered whenever the score is equal to
or greater than 4 points, the higher the score, the higher the
fatigue (Mota, Pimenta, and Piper, 2009). It has already
been demonstrated that the Piper Severity Scale-Revised is
a reliable (r ≥ 0.60, p ≤ 0.01) and valid instrument to
measure fatigue in Brazilian patients, as the internal con-
sistency was adequate (Cronbach’s α ranged from 0.84 to
0.94 for the total scale and its dimensions) (Mota, Pimenta,
and Piper, 2009).
Mcgill pain questionnaire
It is composed of four parts: 1) sensory dimension; 2)
affective dimension; 3) evaluative dimension; and 4) mis-
cellaneous. The Brazilian version consists of 78 pain
descriptors, grouped into 20 categories. The categories
from 1 to 10 represent sensorial characteristics of pain.
Categories 11 through to 15 represent affective character-
istics. Category 16 represents evaluative pain, and categories
4 A. C. S. FONSECA ET AL.
17 to 20 represent miscellaneous factors. At the end of the
application of the questionnaire, the evaluator has access to
two types of information: 1) number of descriptors (max-
imum of 20 descriptors), where the higher the number of
descriptors, the worse the pain is; and 2) pain index (max-
imum of 78 points), where it is considered the numerical
value corresponding to each of the chosen descriptors and
the higher the score the worse the perceived pain is (Varoli
and Pedrazzi, 2006). The McGill Pain Questionnaire has
demonstrated adequate clinimetric properties: high levels
of internal consistency (Cronbach’s α ranged from 0.70 to
0.79); reliability (intraclass correlation coefficient ranged
from 0.69 to 0.85); and agreement (standard error of the
measurement ranged from 0.80 to 6.92).
Fibromyalgia impact questionnaire
Composed of 20 questions subdivided into 10
groups. The first group focuses on issues related
to performing daily tasks. The score of this part is
calculated through the arithmetic average of the
questions answered. The answers have values from
0 to 3 (0 = always able to perform and 3 = never
able to perform). In the second and third groups,
the volunteer should indicate the number of days
he or she felt good and the number of days he or
she was absent from work because of FM, to which
each receives values from 0 to 3 (from 0 = always
able to perform thru and 3 = never able to per-
form). The last seven groups focus respectively on
ability to work, pain, fatigue, morning tiredness,
stiffness, anxiety and depression. They are all mea-
sured by a numerical scale from 0 to 10 (0 being
the best possible up to 10 as being the worst pos-
sible). In the final calculation, the scores of the
three initial items vary from 0 to 10. Thus, the
instrument has a total score ranging from 0 to
100; the higher the number, the worse the impact
on the individual’s life (0 = best index and
100 = worst index) (Marques et al., 2006).
According to a previous study, FIQ presented ade-
quate clinimetric properties: internal consistency
(Cronbach’s α of 0.83); test-retest/stability (ranged
from 0.56 to 0.95); construct validity (ranged from
0.50 to 0.95) (Hedin, Hamne, Burckhardt, and
Engstrom-Laurent, 1995); and concurrent validity
with the Fibromyalgia Impact Questionnaire
Revised (FIQ-R) (r = 0.88 and p ≤ 0.01) (Bennett
et al., 2009b).
Intervention
The intervention process started in April 2016 and
ended in June 2016. Both interventions lasted
eleven weeks, with a one week pause between the
sixth and the seventh week. This pause is described
in the original ISF protocol (Souza, Bourgault,
Charest, and Marchand, 2008). It was applied in
both groups (ISF and AP) to avoid temporal varia-
tions between them.
Aquatic physiotherapy
Every week, a 60-minute AP session was held.
A one-week pause was added between the sixth
and the seventh week of treatment to equal the
two protocols used in the study. The exercise inten-
sity was moderate (around 50% of maximum heart
rate) (Silva et al., 2012), monitored continuously by
a waterproof cardio-frequency meter. Blood pres-
sure and respiratory rate were checked at the begin-
ning and at the end of each session. In total, nine
AP sessions were held.
The AP protocol was divided into four phases: 1)
warming up (5 min); 2) muscle stretching (15 min); 3)
free active exercises (30 min); and 4) relaxation
(10 min). The detailed timeline is shown in Table 1.
The water temperature was 32°C (89,6°F) during the
session. During the service, two properly trained
researchers conducted the exercises and provided the
necessary support and safety. Table 1 shows the activ-
ities developed during the treatment with the patients
of the Aquatic Physiotherapy (AP) group.
Inter-relational school of fibromyalgia
The ISF is HEP model designed for people with
FM. It aims at raising awareness and at teaching
coping strategies in addition to self-treatment tech-
niques for people with FM. ISF was offered once
a week. As already mentioned, during this period
there was a one week pause between the sixth and
the seventh week. According to the original proto-
col of the ISF, this pause aims at encouraging the
autonomy and independence of the participants
(Souza, Bourgault, Charest, and Marchand, 2008).
Nine meetings, lasting 60 minutes each, were per-
formed during the study.
Every meeting had a different theme addressed.
They included therapeutic contract, senses explora-
tion, mental preparation, physical preparation,
stress and individuality, symptoms, nutrition, con-
sequences of chronicity, treatment of FM and retro-
spective. At the meetings, the volunteers were
encouraged to spend 45 minutes of their day
doing the activities proposed by theISF (Souza,
Bourgault, Charest, and Marchand, 2008). The sche-
dule of actions performed at ISF is shown in
Table 2.
PHYSIOTHERAPY THEORY AND PRACTICE 5
Statistical analysis
The IBM SPSS® statistical package version 22 was used
for data analysis. The Shapiro-Wilk test was used to
verify the data distribution. To evaluate the between
group differences at baseline, Student’s t-tests were used
for independent measurements and Mann-Whitney
according to the data distribution. The two-way mixed
measures analysis of variance with Bonferroni correction
was used to analyze the effects of the two treatments on
primary outcomes in three different assessments (two
groups x three times). The effect size (partial eta; n2)
was calculated to illustrate the magnitude of the within-
group and between-group differences for each variable.
We considered a value equal to or greater than 0.51 for
large effects and a value equal to or greater than 0.0830
for medium effects (Richardson, 2011). The level of sig-
nificance was α = 0.05.
Results
The study initially recruited 53 women interested in
participating, however, 7 could not participate (5
did not have the diagnosis confirmed by the spe-
cialist and 2 had a BMI greater than 30 kg/cm2).
The final study sample consisted of 46 women with
FM who were randomized into AP group (n = 27)
Table 1. Schedule of actions performed by the AP treatment.
Performed activities Time
Warming Up Walk along the entire length of the pool straight to the front, to the
back and with side pass.
Five minutes (5ʹ)
Muscle stretching Stretching of upper and lower limbs and of the dorsal musculature. Fifteen minutes (15ʹ). The position of each stretching was
maintained for 60 seconds (60 ‘‘) and performed once for
each muscle/muscle group.
Active Exercises Exercises for upper and lower limbs. Initially without external load
and evolving to exercises using foam pool noodles and water
weights ranging from 0.5 to 1 kg.
Thirty minutes (30ʹ) (three sets with twelve repetitions for
each exercise proposed).
Relaxation Active stretching of upper and lower limbs and posterior and
anterior trunk chains associated with respiratory exercises.
Ten minutes(10ʹ).
Table 2. Schedule of actions performed at the ISF.
Meeting Theme Objetives
1a – Therapeutic contract
1b-Senses exploration
Introduce briefly the nine stages of the program and negotiate the therapeutic contract. This contract aims to modulate
the patients’ expectations and consists of: a) define three realistic and measurable personal goals; b) determine the
lowest acceptable percentage of improvement, in the clinical condition (between 5% and 20%). On the contract, the
participants also commit to dedicate 45 minutes/day, 6
days/week to the activities prescribed by the ISF as: relaxation techniques, diaphragmatic breathing, stretching,
strengthening and aerobic exercises.
Promote the experimentation of the sensory organs. Discuss the ways that people feel and perceive the world and the
reality around them. Demonstrate the deep diaphragmatic breathing.
2 – Mental Preparation Demonstrate that the environment perceptions are related to previous experiences and the perception of pain, as well as
other symptoms, can also be influenced by previous experiences. Demonstrate some mental preparation techniques and
facing strategies to deal with pain. Practical Yoga class with an emphasis on meditation. The participant is going to
choose a relaxation technique and practice it 3 times/week for 15 to 20 minutes *.
3 – Physical preparation Discuss the effects of physical inactivity and physical activity. Demonstrate warm-up, stretching, strengthening and
aerobic exercises. Perform calculations to identify HRmax. Practical Pilates class on the ground. To prescribe an exercise
program to be performed at home *: a) exercise routine: 6 times/week, 15 minutes, with stretching and strengthening; b)
walking, moderate intensity 40% to 60% HRmax; 3 times/week; 30 minutes*.
4 – Stress and individuality Study the hypothalamic-pituitary-adrenal axis and its importance in homeostatic systems and in stress. Discuss facing
strategies that contribute to the understanding and improvement of individual levels of energy/disposition (learning to
say no when necessary, postponing or delegating tasks in times of greatest suffering, observing and valuing oneself).
5 – Symptoms To study the mechanisms involved in pain, fatigue, muscle rigidity, sleep disorders, anxiety and depression.
6 – Nutrition Discuss the basic components of a balanced and healthy diet, the benefits of hydration and the harm provided by foods
high in sugars, fats and/or sodium.
PAUSE Two weeks of autonomous work: integration of strategies individually (without meeting with therapists).
7 – Consequences of chronicity To discuss the influence of chronic pain on emotional aspects, interpersonal relationships, daily living activities and
sexuality. Discuss aspects related to suicidal thoughts.
8 – Treatment To present and discuss, based on scientific evidence, the main types of pharmacological and non-pharmacological
treatment currently used for the treatment of fibromyalgia.
9 – Retrospective Motivate patients to continue prescribed activities. Performing a retrospective of the subjects covered
*Source: Adapted from Souza, Bourgault, Charest, and Marchand (2008).
**All prescribed activities are cumulative and should be maintained throughout the study period. At the end of each meeting, the participants received
a notebook with a list of activities that should be performed during the week. The completed activity book was returned to the researchers at the
beginning of the next meeting. All meetings were held on Wednesdays from 08:00 A.M. to 09:00 A.M. or on Thursdays from 05:00 P.M. to 06:00 P.M.,
depending on the availability of the participant.
6 A. C. S. FONSECA ET AL.
and ISF group (n = 19). The imbalance between the
number of participants in the groups was caused by
the randomization method used. At the baseline the
characteristics of participants were similar in both
groups with respect to age, BMI and diagnosis time
at the beginning of the study (Table 3). At the
baseline, overall the participants had more intense
pain and fatigue complaints, sleep disturbances,
mild to moderate depression symptoms, moderate
anxiety and impact on quality of life.
Table 3. Characterization of participants who completed all the stages of the research.
AP group (n = 27) ISF group (n = 19)
Average ± SD CI95% Average ± SD CI95% p value
Age (years) 53.78 ± 10.40 49.66 a 57.89 54.47 ± 11.18 49.09 a 59.86 0.83
BMI (Kg/m2) 27.15 ± 5.88 24.82 a 29.47 29.37 ± 5.14 26.89 a 31.84 0.19
Diagnostic Time 5.89 ± 4.02 4.26 a 7.51 7.89 ± 6.90 4.57 a 11.22 0.46
AP = aquatic physiotherapy; ISF = interrelated Fibromyalgia school; SD = standard deviation; BMI = body mass index; 95% CI = 95% confidence
interval.
FIQSLEEP DEPRESSION
ANXIETY FATIGUEPAIN descriptors
PAIN index
Figure 2. Within-group and between-group differences throughout the study.
LEGEND: FIQ = Fibromyalgia Impact Questionnaire. The Aquatic Physiotherapy (AP) intervention group is represented by the continuous
lines and the Health Education Program (HEP) intervention group is represented by the broken lines.
PHYSIOTHERAPY THEORY AND PRACTICE 7
The two-way mixed ANOVA demonstrated that there
was an effect on functional capacity [F(1.82,80.41) = 31.99;
p ≤ 0.01], in sleep [F(1.71,75.08) = 14.42; p ≤ 0.01], in
depression [F(1.43,62.93) = 11.08; p ≤ 0.01] and anxiety
[F(1.34,58.34) = 18.98; p ≤ 0.01] from the post-test to the
other measurements in both groups (Figure 2). An effect
on fatigue was observed [F(1.00,44.00) = 7.07; p ≤ 0.05] only
in the ISF group. There was no evidence of pain in any of
the indicators.
The results showed that there was interaction
between-group and time only for the functional capacity
measured by FIQ [F(1.82,80.41) = 31.99; n2 = 0.125;
p ≤ 0.05), although the effect of the intervention groups
for each of the depressionmeasures was borderline
(Table 4). For all other variables, the effect of the inter-
vention was not statistically different between-group.
Discussion
This study investigated the effects of two intervention
programs in people with FM. The within-group results
showed that both interventions seem to have contrib-
uted to the improvement of the different outcomes,
however, the absence of comparison of the interven-
tions with a non-active group, does not allow to affirm
that these interventions are effective for each of
the outcomes of interest. On average, there was an
improvement of 13.1% (range of 11.8% to 23.8%) in
the outcomes evaluated with PA and 23.2% (range of
18.4% to 37.2%) with the ISF. Although the results are
slightly favorable to ISF, the two programs had mini-
mally important clinical effects for chronic diseases
considering short-term interventions (Arya, Verma,
and Garg, 2011; Bennett et al., 2009a).
Within-group results of AP group showed that sleep
quality, depression, anxiety, and functional capacity under-
went significant changes during the study period. The
heated water can potentiate the parasympathetic response
and modulate the sympathetic response (Salvador, Dias,
and Zirbes, 2005). Such modulation leads to a reduction
in the release of stress-related hormones such as adrenaline,
noradrenaline and cortisol (Marketon andGlaser, 2008). In
addition, these hormones influence sleep and behavior
patterns (Marketon and Glaser, 2008). Furthermore, per-
forming exercises in warmwater and withminimal friction
allows the release of serotonin, the neurotransmitter related
to the state of well-fare (Bagdatli et al., 2015; Silva et al.,
2012; Zamuner et al., 2015). It is also possible that the AP
contributed to the improvement of the self-esteem of the
participants, as demonstrated by others studies (Bagdatli
et al., 2015; Lima et al., 2013) which may attenuate the
symptoms of anxiety (Silva et al., 2012). However, in this
study, self-esteem was not evaluated and, therefore, is
a hypothesis that should be addressed in future studies.
The effects observed on sleep quality during AP treat-
ment can also be justified, at least partially, by the serotonin
release associated with physical exercise. It has already been
demonstrated that patients with FM who participated in
aerobic exercises performed in heated water had
a significant increase in the serotonin release (Silva et al.,
2012; Zamuner et al., 2015). This fact may be clinically
relevant since serotonin is a precursor of melatonin, and
this is a hormone known to be related to the initiation and
maintenance of sleep, and that significantly lower levels of
melatonin have been recently identified in individuals with
FM (Pernambuco et al., 2015).
It has also been described that people with FM
tend to have a significant impairment of functional
capacity, mainly because they are inclined to have a:
decrease of muscular conditioning; increased mus-
cular micro-injuries; increased chronic fatigue and
pain; and reduced blood perfusion and oxidative
stress (Chaitow, 2002; Pernambuco, Schetino,
Carvalho, and Reis, 2016). In this study there was
a significant within-group change in the functional
capacity of the individuals treated through AP. This
Table 4. Descriptive and inferential statistics for the measurements of the primary outcomes according to the intervention with
aquatic physiotherapy (AP) and inter-relational school of fibromyalgia (ISF).
AP group (n = 27) ISF group (n = 19) Mix ANOVA
Pre-intervention 6 weeks Post-intervention Pre-intervention 6 weeks Post-intervention Group by time
Primary outcomes Average (SD) Average (SD) Average (SD) Average (SD) Average (SD) Average (SD) F p n2
Sleep 10.9 (4.0) 9.7 (3.9) 8.4 (3.2) 10.1 (3.8) 9.3 (3.4) 7.3 (3.8) 0.100 0.87 0.002
Depression 18.3 (7.7) 18.5 (7.0) 15.4 (7.7) 18.8 (6.8) 14.5 (4.1) 13.1 (6.7) 3.118 0.06 0.066
Anxiety 23.1 (10.7) 20.0 (11.8) 17.6 (11.7) 24.9 (8.7) 21.2 (9.9) 15.5 (9.9) 1.535 0.22 0.034
Fatique 5.1 (1.9) 4.6 (1.6) 4.5 (1.5) 4.9 (1.6) 4.3 (1.3) 4.0 (1.2) 0.295 0.71 0.007
NWC 18.0 (3.9) 18.6 (2.4) 18.3 (2.5) 16.8 (5.2) 16.2 (5.2) 15.9 (5.0) 0.872 0.40 0.019
PRI 47.0 (15.2) 46.6 (13.1) 44.8 (13.1) 37.3 (14.9) 35.8 (15.6) 35.3 (15.8) 0.087 0.92 0.002
FIQ 58.4 (16.3) 53.3 (14.6) 49.9 (11.6) 57.8 (14.8) 48.6 (10.2) 36.3 (16.2) 6.279of cortisol and anti-inflammatory cytokines
in people with FM (Pernambuco et al., 2018, 2017, 2013).
All these changes together can contribute to the installation
of an inflammatory process that impairs metabolism and
muscle efficiency, resulting in increased fatigue perception
(Dell’Osso et al., 2015). However, in the present study, no
biomarker was analyzed to confirm this hypothesis.
The only outcome with significant differences between
groups was the impact of FM on participants’ lives. These
changes that occurred in favor of the ISF group corrobo-
rate studies already published that used behavioral strate-
gies to treat FM. One study evidenced positive changes in
the impact of FM, measured by FIQ, in patients submitted
to cognitive-behavioral therapy. The authors also observed
improvements in anxiety levels and post-intervention
depression (Menga et al., 2014). Another study also
demonstrated improvements in anxiety, stress and depres-
sion symptoms in people with FM through mind training
work (Amutio et al., 2014). A considerable improvement
in the quality of life of HEP participants for individuals
with FM has also been demonstrated (Musekamp et al.,
2016; Pernambuco et al., 2018). This improvement is
supported by the enhancement of coping strategies and
self-treatment, discussed, trained and encouraged during
the educational programs (Souza, Bourgault, Charest, and
Marchand, 2008). A previous study performed by our
group reported that behavioral and subjective changes
are accompanied by changes in inflammatory and neu-
roendocrine markers, such as anti-inflammatory cytokine
levels, salivary cortisol and an urinary melatonin metabo-
lite of patients who participated in the ISF (Pernambuco,
2014; Pernambuco et al., 2018).
There was no within-group or between-group signifi-
cant differences in outcome pain, diverging from the
literature (Lima et al., 2013; Souza, Bourgault, Charest,
and Marchand, 2008). However, the response of these
symptoms during FM treatments needs further studies.
Despite the effect of different treatments on reduction
PHYSIOTHERAPY THEORY AND PRACTICE 9
of pain in people with FM to be widely accepted,
a systematic review and meta-analysis showed that pain
can be enhanced with exercise. Because of exercise intol-
erance reports by some people with FM, very long and
high intensity exercises are discouraged in order to avoid
exacerbation of symptoms, especially pain (Cerrillo-
Urbina, García-Hermoso, Sánchez-López, and Martínez-
Vizcaíno, 2015).
In our study, the pain indicators remained almost
unchanged throughout the three months of intervention
in both treatment groups. Perhaps, the duration of the
intervention has not been sufficient enough to generate
positive responses on self-reported pain, since relief of
this symptom may occur only in the long term (Altan,
Korkmaz, Bingol, and Gunay, 2009). Nevertheless, we
recognize the positive effect of the therapy pool on the
pain of individuals with FM (Cuesta-Vargas and Adams,
2011; Lima et al., 2013). These improvements seem to
persist even in the long term (Mannerkorpi, Ahlmen, and
Ekdahl, 2002; Tomas-Carus et al., 2008). In the pioneer-
ing study on ISF, the authors also demonstrated improve-
ment in pain reported by the participants (Souza,
Bourgault, Charest, and Marchand, 2008).
The pioneering study on ISF showed a significant
improvement in pain, emotional aspects, daily life activ-
ities and better life control in those submitted to treat-
ment when compared to an untreated control group
(Souza, Bourgault, Charest, and Marchand, 2008). In the
present study the outcomeswere different, but once again,
they may suggest that ISF is a good non-pharmacological
alternative to relieve FM symptoms. The within-group
changes observed, although clinically important and cor-
roborating with the literature, cannot be attributed exclu-
sively to the effects of interventions, since the absence of
a non-active control group impairs the analysis of the
efficacy of the proposed interventions. Since, it is not
possible to control some confounders, such as: natural
history of the disease, placebo effect, Hawthorne effect,
regression to the mean, recall bias, among others. We
acknowledge this limitation of the study and intend to
address this issue in future studies.
Advantages and limitations of the present study
should be discussed. An advantage to be emphasized
is the absence of losses during treatments. Previous
researches have evidenced the low treatment adherence
of patients with FM (Trevisan et al., 2015), but we
believe that the care provided by properly trained
researchers has captivated and at the same time offered
support and safety to the volunteers. To prevent the
loss of patients, we adopted strategies that had already
worked in previous studies (Fonseca, Faria, and
Pernambuco, 2016; Pernambuco, 2014; Pernambuco
et al., 2018; Souza, Bourgault, Charest, and Marchand,
2008). For this purpose, a pilot study was conducted
previously (Fonseca, Faria, and Pernambuco, 2016), the
intervention was planned according to the biopsycho-
social profile of the participants (Pernambuco et al.,
2016a), the schedule of the meetings was agreed
between the parties, in both groups the relationship
between researchers and volunteers was cordial, the
educational approach was transversal and performed
dynamically, with practical activities and examples
applicable to the participants’ reality. In addition, the
study was conducted in a country town, where there is
a certain lack of treatment options and poor informa-
tion for understanding the disease. Thus, a new therapy
option, with new perspectives on the clinical condition,
serves as an incentive for adherence to treatment.
We believe that the main strength of the study lies in
the proposed methodology and in the multiple outcomes
presented. The randomized clinical trial is considered the
gold standard by the World Health Organization (WHO)
to test interventions (World Health Organization, 1996)
and the number of outcomes analyzed allows the mon-
itoring of the various symptoms and comorbidities that
are part of the clinical picture of FM (Sarzi-Puttini et al.,
2012b). The FM is a syndrome with a high heterogeneous
clinical picture, it is believed that a great understanding of
the impact caused by the symptoms and comorbidities,
observed from the perspective of the biopsychosocial
model, may offer better parameters for the establishment
of the clinical reflection and the decisionmaking based on
the real needs of individuals with FM, contributing not
only to improvement in health, but all aspects related to
the health of these patients, as recommended by WHO
(Hieblinger et al., 2009).
One of the main limitations of the study was that the
sample was restricted to adult women, close to the meno-
pause stage. It is possible that some of them have already
passed through the climacteric period, while others have
not. This fact may have interfered in the study outcomes,
due to hormonal variations, especially those related to
estrogen levels (Lisboa et al., 2015). However, the exclu-
sive inclusion of women can also be positive, after all, the
men’s participation in the sample could result in confir-
mation bias. Another limitation of the present study was
the absence of a follow-up period after the end of the
study. This period could demonstrate whether the results
persist over time. This issue will be addressed in future
studies. The randomization method used was another
important limitation of the study. The use of 100 envel-
opes for only 46 participants caused an imbalance in the
number of components in the study groups. The rando-
mization method allowed the study participants to take
cognizance of the two types of intervention that would be
compared. It should also be noted that the lack of
10 A. C. S. FONSECA ET AL.
a sample calculation may have resulted in type II error.
The lack of more detailed clinical data at the time of
randomization, such as data on disease duration, conco-mitant diseases, pharmacological treatment is recognized
by the authors as a limitation of the study. Finally, the
absence of a non-active control group does not allow to
affirm that within the group differences have been pro-
voked only by the interventions used.
Conclusion
The findings do not allow to affirm that one intervention
is superior to the other for the treatment of people with
FM. Within-group changes occurring during the study
period in both groups, although clinically important,
cannot be attributed exclusively to the effects of the
intervention used. Between-group analyzes suggest that
ISF may have a greater effect only on the impact of FM
on participants’ lives than PA. Therefore, to choose one
technique over the other, the health professional should
consider the clinical skills, symptomatology and the
patient’s preference. It is possible that the techniques
evaluated in this study are not competing among them-
selves but are complementary to each other. Future stu-
dies should evaluate the effectiveness of the combination
of HEP and AP for the treatment of people with FM.
Acknowledgments
The authors are grateful to Fundação de Amparo à Pesquisa
do Estado de Minas Gerais (FAPEMIG) and Centro
Universitário de Formiga – MG (UNIFOR-MG) for their
logistical and financial support.
Funding
This work was supported by the Centro Universitário de
Formiga - MG; Fundação de Amparo de Pesquisa do
Estado de Minas Gerais.
Disclosure statement
The authors declare no conflict of interest.
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Lisboa LL, SoneharaConclusion
	Acknowledgments
	Funding
	Disclosure statement
	ReferencesConclusion
	Acknowledgments
	Funding
	Disclosure statement
	References