Quality of life related to foot health status in women with fibromyalgia: a case-control study

Abstract

Introduction:
To date, the Foot Health Status Questionnaire (FHSQ) has not been applied to women who suffer from fibromyalgia. The main purpose of this study was to compare both foot and general health-related quality of life between women with fibromyalgia and healthy matched women. We hypothesized that women with fibromyalgia may present an impaired quality of life related to foot and general health.

Material and methods:
A sample of 208 women, mean age of 55.00 ±8.25 years, was recruited from an outpatient clinic and divided into 2 groups, 104 women with fibromyalgia (for the case group) and 104 healthy matched women (for the control group). Demographic data and the domains of the FHSQ scores were registered.

Results:
Statistically significant differences (p < 0.001) between case and control groups were found for both all specific foot domains (pain, foot function, foot health and footwear) and all general wellbeing domains (general health, physical activity, social capacity and vigor), showing a worse foot and general health-related quality of life (with lower scores for all FHSQ domains) in the women with fibromyalgia compared to healthy matched women.

Conclusions:
Impaired foot and general health-related quality of life was observed in women who suffered from fibromyalgia compared to healthy matched women.

Full text

Clinical research
Rheumatology
Corresponding author:
César Calvo Lobo PhD
Nursing and
Physiotherapy
Department
Institute of Biomedicine
(IBIOMED)
Faculty of
Health Sciences
Universidad de León
Av. Astorga
24401 Ponferrada
León, Spain
Phone: +34 987442053
E-mail: cecalvo19@hotmail.com
1
University Center of Plasencia, Universidad de Extremadura, Spain
2 Nursing and Physiotherapy Department, Institute of Biomedicine (IBIOMED),
Faculty of Health Sciences, Universidad de León, Ponferrada, León, Spain
3 Faculty of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid,
Madrid, Spain
4 Faculty of Health Sciences, Universidad Rey Juan Carlos, Madrid, Spain
5 Universidad Europea, Faculty of Sport, Madrid, Spain
6 Research, Health and Podiatry Unit, Department of Health Sciences,
Faculty of Nursing and Podiatry, Universidade da Coruna, Coruna, Spain
Submitted: 2 June 2018
Accepted: 26 June 2018
Arch Med Sci 2019; 15 (3): 694–699
DOI: https://doi.org/10.5114/aoms.2018.77057
Copyright © 2018 Termedia & Banach
Quality of life related to foot health status in women
with fibromyalgia: a case-control study
Patricia Palomo-López1, César Calvo-Lobo2, Ricardo Becerro-de-Bengoa-Vallejo3,
Marta Elena Losa-Iglesias4, David Rodriguez-Sanz3,5, Rubén Sánchez-Gómez3, Daniel López-López6
Abstract
Introduction: To date, the Foot Health Status Questionnaire (FHSQ) has not
been applied to women who suffer from fibromyalgia. The main purpose of
this study was to compare both foot and general health-related quality of
life between women with fibromyalgia and healthy matched women. We hy-
pothesized that women with fibromyalgia may present an impaired quality
of life related to foot and general health.
Material and methods: Asample of 208 women, mean age of 55.00 ±8.25
years, was recruited from an outpatient clinic and divided into 2 groups,
104 women with fibromyalgia (for the case group) and 104 healthy matched
women (for the control group). Demographic data and the domains of the
FHSQ scores were registered.
Results: Statistically significant differences (p < 0.001) between case and
control groups were found for both all specific foot domains (pain, foot func-
tion, foot health and footwear) and all general wellbeing domains (general
health, physical activity, social capacity and vigor), showing aworse foot
and general health-related quality of life (with lower scores for all FHSQ
domains) in the women with fibromyalgia compared to healthy matched
women.
Conclusions: Impaired foot and general health-related quality of life was
observed in women who suffered from fibromyalgia compared to healthy
matched women.
Key words: fibromyalgia, foot, foot injuries, musculoskeletal pain, quality
of life.
Introduction
Fibromyalgia may be considered as the most frequent central sensi-
tization syndrome, with ahigher prevalence in women who suffer from
chronic widespread pain and other symptoms that lead to considerable
functional impairment [1]. Its prevalence may reach up to 2.10% of the
worldwide population, 2.31% of the European population, and 2.40% of

Quality of life related to foot health status in women with fibromyalgia: a case-control study
Arch Med Sci 3, May / 2019 695
the Spanish population. This painful syndrome
may cause quality of life impairment in women
who suffer it. In Spain, enormous economic costs
were reported and reached up to 12,993 million
euros per year [2].
Women were more likely to suffer from fibro-
myalgia, showing a younger age than patients
diagnosed with other pain conditions and higher
presence of several psychiatric comorbidities com-
bined with other types of pain, such as headaches
and connective tissue diseases. Consequently,
women with fibromyalgia seemed to show ahigh-
er demand of medical outpatient services use [3].
Regarding health-related quality of life ques-
tionnaires applied to women who suffered from
fibromyalgia, general quality of life tools, such as
the EuroQoL 5-Dimensions 5-Levels (EQ-5D-5L) [4],
15-Dimensions (15D) [5], Assessment of Quality
of Life 8-Dimensions (AQoL-8D) [6], Short Form
Health Survey 12-item (SF-12) [7] and 36-item
(SF-36) [8], and specific condition tools, such as the
Fibromyalgia Impact Questionnaire (FIQR) [9], were
used with adequate correlations between these
questionnaires in this kind of population [10].
Although women with fibromyalgia did not
seem to show ahigher prevalence of stiffness or
mobility abnormalities as well as hyperkeratosis
or other foot problems, these patients may ex-
perience significantly more pain in the foot than
healthy subjects and, consequently, demand more
pain-killing drugs [11]. Based on these anteced-
ents, foot health-related quality of life measure-
ments may be necessary in order to determine the
impact of fibromyalgia in women who suffer from
this syndrome. For this purpose, the Foot Health
Status Questionnaire (FHSQ) may be considered
a foot and general health-related quality of life
tool with specific foot domains (pain, foot func-
tion, foot health and footwear) and general well-
being domains (general health, physical activity,
social capacity and vigor) [12, 13].
To date, the FHSQ has not been applied to wom-
en who suffer from fibromyalgia [12, 13]. Thus,
the main purpose of this study was to compare
both foot and general health-related quality of life
between women with fibromyalgia and healthy
matched women. We hypothesized that women
with fibromyalgia may present an impaired quali-
ty of life related to foot and general health.
Material and methods
Study design
An observational case-control study was per-
formed following the Strengthening the Report-
ing of Observational Studies in Epidemiology
(STROBE) criteria [14]. From March to May 2018,
asample of 208 women was recruited by acon-
secutive sampling method from auniversity po-
diatric medicine and surgery unit which provided
interventions for foot problems at the University
of Extremadura (Plasencia, Spain).
Sample size calculation
The sample size was calculated by means of
the difference between two independent groups
using the G*Power 3.1.9.2 software [15] and the
foot pain domain score (mean ± SD) from the
FHSQ [12, 13] of aprior pilot study (n = 30) with
two groups. Acase group of 15 patients with fibro-
myalgia (FHSQ score for foot pain domain of 38.58
±24.35) and ahealthy matched control group of
15 subjects (FHSQ scores for foot pain domain
score = 56.26 ±29.23) were used for the data anal-
ysis. Furthermore, a2-tailed hypothesis, an effect
size of 0.65, an α error probability of 0.01, apow-
er (1 – β error probability) of 0.95, and an alloca-
tion ratio (N2/N1) of 1 were used in order to carry
out the sample size calculation. Therefore, atotal
sample size of 170 participants, with 85 subjects
per each group, was determined. Considering
20% of possible subjects lost to follow-up, 204 sub-
jects would be necessary. Finally, 208 participants,
104 cases with fibromyalgia and 104 healthy
matched controls, were included in the study.
Patients
A sample of 208 women, mean age of 55.00
±8.25 years, was recruited from an outpatient
clinic and divided into 2 groups, 104 women with
fibromyalgia (for the case group) and 104 healthy
matched women (for the control group).
For the control group, women older than 18
years old were included in the healthy-matched
control group if they reported no spontaneous or
chronic pain (at least during the prior 3 months)
and no pain-related conditions and were not tak-
ing antidepressant or analgesic medications [16].
For the case group, women older than 18
years old diagnosed with fibromyalgia according
to a validated experienced rheumatologist diag-
nosis, based on acombination of both 1990 and
modified 2010 criteria, were included [16–20].
Tender points were positively screened if patients
experienced pain under a4 kg pressure by means
of digital palpation located at the 18 points pro-
posed by the American College of Rheumatology
[17]. In addition, the presence of fatigue, sleep dis-
orders and other self-reported symptoms by the
patient was considered [18].
Exclusion criteria considered for both groups
were women older than 18 years old, prior exis-
tence of other types of rheumatic diseases differ-
ent from fibromyalgia, neurological alterations,
other systemic, neoplastic or inflammatory condi-

P. Palomo-López, C. Calvo-Lobo, R. Becerro-de-Bengoa-Vallejo, M.E. Losa-Iglesias, D. Rodriguez-Sanz, R. Sánchez-Gómez, D. López-López
696 Arch Med Sci 3, May / 2019
tions, diagnosis of psychiatric illnesses (e.g. schizo-
phrenia), non-controlled endocrine conditions
(e.g. hyperthyroidism, hypothyroidism or diabetes),
pregnancy, non- or semi-independence in daily life
activities, and difficulties understanding the in-
structions for completing the research course [16].
Outcome measurements
Demographic data such as age, height, weight,
and body mass index (BMI) were collected before
self-reporting the questionnaire. The Spanish vali-
dated self-FHSQ (1.03 Version) was composed of
3 sections. Section one was composed of 13 ques-
tions and divided into 4 specific domains regard-
ing foot health-related quality of life: foot function
(four questions), foot pain (four questions), foot-
wear (three questions), and general foot health
(two questions). Adequate content, criterion, and
construct validity (Cronbach α from 0.89 to 0.95)
and test-retest intraclass correlation coefficient re-
liability (ICC from 0.74 to 0.92) were reported for
section one. Section two was composed of 4 over-
all health-related quality of life domains (physical
activity, general health, social capacity and vigor),
whose questions were largely adapted from the
SF-36 [21]. Finally, section three included descrip-
tive data such as socioeconomic status, comorbidi-
ties, satisfaction or medical record data. Each ques-
tion showed several responses by means of aLikert
ordinal scale, including only 1 response as the most
correct. This tool generated different scores for each
domain obtained by means of computer software,
whose scores varied from 0 to 100. Considering the
health-related quality of life, ascore of 0 indicat-
ed the worst health status while 100 indicated the
best health status [12, 13, 22, 23].
Ethics considerations
The Bioethics and Biosafety Committee of the
Extremadura University (Spain) approved this
study (approval code: 24/2018). All voluntary
women signed the informed consent forms before
beginning this study. Ethical standards concerning
research on human beings according to the Hel-
sinki Declaration (World Medical Association) and
the Council of Europe Convention about human
rights and biomedicine, and those standards of
the UNESCO Universal Declaration about the Hu-
man Genome and Human Rights, as well as other
national or institutional rules, were respected [24].
Statistical analysis
The FHSQ (v1.03) was used to obtain the foot
and general health related quality of life scores.
In all analyses, statistically significant differences
with aP-value < .01 and aconfidence interval (CI)
of 99% were considered. Furthermore, all analyses
were performed by means of the SPSS 22.0 soft-
ware (Chicago, IL, USA).
First, the Kolmogorov-Smirnov test was used to
assess normality, and a normal distribution was
considered with p-value > 0.01. Demographic data
and FHSQ domains were non-parametric data. Thus,
median and interquartile range (IR) as well as maxi-
mum and minimum (range) values were used to de-
scribe the total sample, women with fibromyalgia
(case group), and healthy matched women (control
group). The Mann-Whitney Utest was applied to as-
sess differences between case and control groups.
Results
Demographic data
Atotal sample of 208 women between 26 and
83 years old with amedian ± IR of 55.00 ±8.25 years
completed the study. The sample was divided into
2 groups, 104 women with fibromyalgia (for the
case group) and 104 healthy matched women (for
the control group). Regarding Table I, demographic
characteristics did not show any statistically signifi-
cant difference (p > 0.01) between the groups.
FHSQ domains
As shown in Table II, statistically significant
differences (p < 0.001) between case and control
groups were found for all specific foot domains
(foot pain, foot function, foot health and footwear)
and general wellbeing domains (general health,
physical activity, social capacity and vigor), showing
aworse foot and general quality of life (with lower
scores of all FHSQ domains) in the women with fi-
bromyalgia compared to healthy matched women.
Discussion
To the authors’ knowledge, the present study
may be considered as the first research applying
the FHSQ [12, 13, 22, 23] which demonstrates
specific impairment of the foot health-related
quality of life. According to the health-related
quality of life questionnaires applied to women
who suffered from fibromyalgia – both general
quality of life questionnaires, such as the EQ-5D-
5L [4], 15D [5], AQoL-8D [6], SF-12 [7] and SF-36
[8], and specific disease questionnaires, such as
the FIQR [9] – our findings showed similar results
with an impaired general-health related quality of
life in women with fibromyalgia [10].
Although women who suffer fibromyalgia show
similar foot characteristics of stiffness or mobility
and hyperkeratosis or other conditions [11], our
study showed aworse foot health related quali-
ty of life compared to healthy women. This may
be due to the fact that these patients present
acentral sensitization process [1] as well as more

Quality of life related to foot health status in women with fibromyalgia: a case-control study
Arch Med Sci 3, May / 2019 697
foot pain and analgesic medication use than the
general population [11]. Prior FHSQ studies have
shown an impaired quality of life in some do-
mains of the specific foot and general health for
specific foot problems such as hallux valgus [25],
calcaneal apophysitis [26], foot arch height [27],
lesser toe deformities [28], plantar heel pain [29,
30], onychomycosis [31] or hyperkeratosis [32],
as well as general conditions such as Alzheimer
disease [33] and breast cancer [34]. Nevertheless,
our findings showed the most significant results
of health-related quality of life impairment for all
foot specific and general domains of the FHSQ
compared to these prior studies.
Implications for clinical practice
Although other studies have previously shown
general health-related quality of life differences
between women with fibromyalgia and healthy
controls [8–10], our study added specific foot
health-related quality of life domains such as foot
pain, foot function, foot health and footwear. For
the medical research field, the present study pro-
vides the quality of life differences related to over-
all health (general health = –29.04; physical activity
= –28.37; social capacity = –24.30; vigor = –22.96
points) and specific foot health (foot pain = –31.69;
foot function = –36.46; foot health = –20.95; foot-
wear = –19.53 points) in women with fibromyal-
gia compared to healthy matched women. Future
interventional studies, i.e. generic treatments such
as pregabalin [35] or specific interventions such as
foot trigger points dry needling [36, 37] and cus-
tom-made foot orthotics [38] in women with fibro-
myalgia, could use these clinical differences as key
references in order to normalize the specific foot
and general health-related quality of life. In line
with prior research [8], we highlight that health
authorities should pay more attention to improving
the general and foot specific health-related quality
of life in women with fibromyalgia.
Table I. Comparison of demographic characteristics of the total sample, women with fibromyalgia and healthy
matched women with normalized reference values
Parameter Total group
Median ± IR
n = 208
Fibromyalgia
Median ± IR
n = 104
Healthy controls
Median ± IR
n = 104
Mann-Whitney U
P-value
Age [years] 55.00 ±8.25 (26–83) 56.00 ±9.00 (26–83) 55.00 ±5.00 (45–82) 0.016
Weight [kg] 70.00 ±15.00 (43–120) 70.50 ±14.00 (50–90) 70.00 ±17.50 (43–120) 0.300
Height [m] 1.60 ±0.07 (1.45–1.79) 1.60 ±0.06 (1.45–1.75) 1.61 ±0.09 (1.50–1.79) 0.166
BMI [kg/m2]27.26 ±5.07 (18.59–43.51) 27.47 ±3.90 (18.59–37.46) 26.48 ±6.74 (18.75–43.51) 0.627
BMI – body mass index, IR – interquartile range. In all the analyses, p < 0.01 (with a99% confidence interval) was considered statistically
significant.
Table II. Comparison of FHSQ scores of the total sample, women with fibromyalgia and healthy matched women
with normalized reference values
Variable Total group
Median ± IR
n = 208
Fibromyalgia
Median ± IR
n = 104
Healthy controls
Median ± IR
n = 104
Mann-Whitney U
P-value
Foot pain 48.12 ±49.38
(0–100)
35.62 ±25.00
(0–90)
76.50 ±34.00
(0–100)
< 0.001
Foot function 59.37 ±57.00
(0–100)
37.50 ±37.50
(0–100)
88.00 ±31.00
(0–100)
< 0.001
Footwear 25.00 ±50.00
(0–100)
00.00 ±41.67
(0–100)
42.00 ±43.67
(0–100)
< 0.001
General foot health 25.00 ±47.50
(0–100)
25.00 ±25.50
(0–85)
43.00 ±35.00
(0–100)
< 0.001
General health 40.00 ±40.00
(0–100)
20.00 ±30.00
(0–90)
60.00 ±30.00
(0–100)
< 0.001
Physical activity 56.00 ±49.67
(0–100)
38.88 ±33.33
(0–100)
78.00 ±38.00
(11–100)
< 0.001
Social capacity 50.00 ±53.13
(0–100)
37.50 ±37.50
(0–100)
75.00 ±38.00
(0–100)
< 0.001
Vigor 37.50 ±31.25
(0–100)
25.00 ±31.25
(0–100)
44.00 ±32.00
(0–100)
< 0.001
FHSQ – Foot Health Status Questionnaire, IR – interquartile range. In all the analyses, p < 0.01 (with a99% confidence interval) was
considered statistically significant.

P. Palomo-López, C. Calvo-Lobo, R. Becerro-de-Bengoa-Vallejo, M.E. Losa-Iglesias, D. Rodriguez-Sanz, R. Sánchez-Gómez, D. López-López
698 Arch Med Sci 3, May / 2019
Some limitations should be considered regard-
ing the present study. First, the consecutive sam-
pling method may be the main limitation of this
research. Second, although adequate validity and
reliability have been shown for the FHSQ [12, 13,
22, 23], its reliability has not yet been established
specifically for women who suffer from fibromy-
algia and should be considered for future studies.
Finally, quality of life could be modified according
to socio-demographic factors such as the origin
of women with fibromyalgia from rural or urban
areas [39] as well as physical factors such as re-
duced bone mineral density [40].
In conclusion, an impaired foot and gener-
al health-related quality of life was observed in
women who suffered from fibromyalgia compared
to healthy matched women.
Conflict of interest
The authors declare no conflict of interest.
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