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Yamamoto 2016
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Yamamoto 2016
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FAIXXX10.1177/1071100716655433Foot & Ankle InternationalYamamoto et al
Article
Foot & Ankle International®
Yohei Yamamoto, MD1, Satoshi Yamaguchi, MD, PhD1, Yuta Muramatsu, MD, PhD1,
Atsushi Terakado, MD, PhD2, Takahisa Sasho, MD, PhD1, Ryuichiro Akagi, MD, PhD1,
Jun Endo, MD, PhD1, Yasunori Sato, PhD3, and Kazuhisa Takahashi, MD, PhD1
Abstract
Background: The purposes of this study were to compare the quality of life (QOL) of subjects who had untreated
symptomatic hallux valgus with the QOL of the general population and to investigate factors associated with the QOL of
the subjects.
Methods: One hundred sixteen subjects with previously untreated and symptomatic hallux valgus were surveyed. QOL
was assessed using the 36-item Short Form Health Survey (SF-36). Additionally, clinical evaluations (the visual analog
scale for pain, Japanese Society for Surgery of the Foot Scale, lesser toe pain, and pain in other parts of the body) and
radiographic evaluations (hallux valgus angle, intermetatarsal angle between the first and second metatarsals, and dislocation
of the second metatarsophalangeal joint) were performed. Differences in the SF-36 between the subjects and the general
population were tested using independent t tests. Correlations between the QOL measurements, clinical evaluations, and
radiographic evaluations were assessed using Spearman rank correlation coefficient.
Results: All SF-36 subscales and physical component summary scores for the subjects were significantly lower than
those of the general population. Notably, the standardized physical function subscale (38.2 ± 15.8, P < .001) and
physical component summary scores (38.9 ± 14.5, P < .001) were more than 10 points lower than those of the general
population. Most QOL and clinical evaluation parameters were not correlated or were negligibly correlated with
radiographic evaluations. Similarly, lesser toe pain or pain in other parts of the body was not correlated with QOL or
clinical evaluations.
Conclusion: The QOL of untreated and symptomatic hallux valgus subjects was lower than that of the general population.
All QOL and clinical evaluation parameters were not significantly or negligibly correlated with the severity of toe deformities.
Surgical decision making should not be based on the severity of the deformity alone, but rather patient QOL should also
be carefully assessed.
Level of Evidence: Level III, comparative series.
SF-36 scores for the general population. This normative HV subjects was 63 years as mentioned in the results. To
data set of the SF-36 provides mean scores of different age clarify factors associated with QOL for HV subjects, corre-
groups, from the 20s to 70s, as well as the overall mean lations between each QOL evaluation (the SF-36 subscale
scores.12,13 The AAOS Foot and Ankle Core Scale and Shoe score and summary score, AAOS Foot and Ankle Core
Comfort Scale are validated subjective scales scored from 0 Scale, and Shoe Comfort Scale), clinical evaluation (VAS
to 100 points, which consist of 20 and 5 questions, respec- for pain and JSSF scale), and age, body mass index, and
tively.17 Clinical evaluations were performed using a visual radiographic evaluation (HV angle and intermetatarsal
analog scale (VAS) for pain15 and the Japanese Society for angle) were assessed using Spearman rank correlation coef-
Surgery of the Foot (JSSF) hallux scale.23 The VAS for pain ficient. Each QOL evaluation item and clinical evaluation
is a 10-cm horizontal scale, ranging from 0 (no pain) to 10 score was compared between patients with bilateral versus
(the worst pain imaginable).15 The JSSF scale is a validated unilateral symptoms, with versus without a painful lesser
objective scale scored from 0 to 100 points, and it consists toe, and with versus without pain in other parts of the body
of 40 points for pain, 45 points for function, and 15 points using the Wilcoxon signed-rank test. Each QOL evaluation
for alignment.23 Higher scores on the JSSF scale indicate a item and clinical evaluation score was also compared
better clinical outcome. Moreover, laterality of the symp- among the patient groups with different grades of second
toms and the presence of lesser toe pain with callosity under metatarsophalangeal joint dislocation using the Kruskal-
the second and/or third metatarsophalangeal joint was Wallis test and Steel-Dwass post hoc test. Patients with
assessed.14 The presence of back, hip, knee, and ankle pain grade 2 and 3 dislocations were combined into one group
was also assessed.26 Six certified orthopedic surgeons, who for the statistical analyses because only 3 subjects had a
were independent of the examiner of the radiographic eval- grade 2 dislocation. Statistical significance was set at P <.05
uations, performed the clinical evaluations. In subjects with for all statistical tests.
bilateral HV, the clinical evaluations were performed on the
more painful side.
Results
The mean pain VAS was 44 ± 28, and the mean JSSF scale
Radiographic Evaluations was 60 ± 16. Forty subjects (34%) had lesser toe pain. Fifty-
Subjects underwent weight-bearing AP and lateral radio- five subjects (47%) had pain in other parts of the body,
graphs of the foot. The HV angle and intermetatarsal angle including back pain (n = 28), hip pain (n = 6), knee pain (n =
between the first and second metatarsals were determined 34), and ankle pain (n = 3). Twenty-five patients had pain in
by the weight-bearing AP radiograph.29,31 Dislocation or 2 or more parts of the body. The mean HV angle and the
subluxation of the second metatarsophalangeal joint often intermetatarsal angle were 40 ± 11 degrees and 17 ± 4
accompanies HV and may produce pain and a callosity degrees, respectively. Twenty-four patients had an HV angle
underneath the second metatarsal head.10 Therefore, dislo- between 20 and 29 degrees, 35 had an HV angle between 30
cation of the second metatarsophalangeal joint was deter- and 39 degrees, and 57 had a severe deformity, with an HV
mined by the weight-bearing lateral radiograph. The degree angle equal to or more than 40 degrees. There were 43 sub-
of dislocation was classified into 4 grades: grade 0 (nor- jects (37%) with second metatarsophalangeal joint disloca-
mal), grade 1 (subluxation with equal or more than 50% of tions. The number of subjects with dislocations of grades 0,
the phalangeal joint surface covering the metatarsal joint 1, 2, and 3 were 73, 30, 3, and 10, respectively.
surface), grade 2 (subluxation with less than 50% of the Standardized values of all SF-36 subscales and physical
joint), and grade 3 (complete dislocation).34 One orthopedic component summary scores for symptomatic HV subjects
surgeon, who was independent of the examiners of the clini- were significantly lower than those of the general popula-
cal evaluations, measured all radiographs. In subjects with tion (P = .015 for general health, P = .009 for mental health,
bilateral HV, the radiographic measurements were per- and P < .001 for others) (Figure 1). Notably, the physical
formed on the more painful side. function subscale (38.4 ± 15.7, P < .001) and physical com-
ponent summary scores (39.0 ± 14.5, P < .001) were more
than 10 points lower than those of the general population.
Statistical Analyses Furthermore, all SF-36 subscales, except for the general
To compare the QOL of HV subjects with the QOL of the health subscale score, for symptomatic HV subjects were
general population, differences in the subscale scores and lower than those of the general population in their 60s
summary scores of the SF-36 were assessed between the (Table 1).
HV subjects and the general population using independent t The HV angle and intermetatarsal angle were not cor-
tests. Additionally, the SF-36 scores of the HV subjects related with most of the QOL or clinical evaluations
were compared with those of the general population in their (Table 2). The correlation between the HV angle and the
60s using independent t tests, because the mean age of the JSSF scale was statistically significant, as were the
Figure 1. Standardized SF-36 values for symptomatic HV subjects. All SF-36 subscales and physical component summary scores for
symptomatic HV subjects were significantly lower than those of the general population. Error bars represent standard deviations.
The mean scores for the general population are 50.
*P < .001, **P = .015, ***P = .009.
SF-36, 36-item Short Form Health Survey; HV, hallux valgus; PCS, physical component summary score; MCS, mental component summary score.
Table 1. Standardized SF-36 values for symptomatic HV subject groups with grade 0, 1, and 2/3 second metatarso-
subjects and the general population in their 60s.11,12 phalangeal dislocations. The mental component summary
Mean ± SDa score for the subjects with a grade 0 dislocation (median,
47.3; range, 32.1-63.3) was significantly lower than that
Present Study 60s of the subjects with a grade 1 dislocation (median, 51.5;
(n = 116) (n = 438) P range, 31.1-73.3) (P = .02). Additionally, the JSSF scale
Physical function 38.2 ± 15.8 46.9 ± 12.3 <.001 scores of the subjects with a grade 0 dislocation (median,
Role-physical 41.7 ± 13.2 49.0 ± 11.5 <.001 62; range, 39-93) were significantly higher than those of
Bodily pain 42.4 ± 8.3 49.7 ± 10.3 <.001 the subjects with a grade 2/3 dislocation (median, 52;
General health 47.7 ± 10.0 48.8 ± 10.3 .30 range, 34-80) (P = .006).
Vitality 45.8 ± 9.6 52.1 ± 10.3 <.001 Similar to the radiographic measurements, age was not
Social function 44.4 ± 12.5 50.3 ± 10.7 <.001 correlated with most of the QOL or clinical evaluations.
Role-emotional 44.2 ± 13.7 50.1 ± 11.2 <.001 There were significant correlations between age and the
Mental health 47.5 ± 10.0 51.8 ± 10.1 <.001 physical function (P = .02), role-physical (P = .04), and
PCS 38.9 ± 14.5 47.6 ± 9.9 <.001 physical component summary scores (P = .004) of the
MCS 49.1 ± 8.4 52.4 ± 9.8 <.001 SF-36. However, the correlations were weak, with the cor-
Abbreviations: MCS, mental component summary score; PCS, physical relation coefficients ranging from −0.19 to −0.26 (Table 2).
component summary score; SD, standard deviation; SF-36, 36-item Body mass index was not correlated with most of the QOL
Short Form Health Survey.
a
and clinical evaluations, except for the mental component
All values for HV subjects were significantly lower than those of the summary score and the AAOS Shoe Comfort Scale. The
general population in their 60s.
correlations were weak, and the correlation coefficients
were 0.19 for the mental component summary score and
correlations between the intermetatarsal angle and both -0.22 for the AAOS Shoe Comfort Scale (Table 2). The
the physical function subscale and mental component QOL and clinical evaluations did not differ between bilat-
summary score of the SF-36. However, the correlations eral versus unilateral symptoms, the presence versus
were weak, with the correlation coefficients ranging from absence of lesser toe pain, or the presence versus absence of
−0.30 to 0.19. There were no significant differences in pain in other parts of the body, except that the general health
most of the QOL and clinical evaluations among the 3 subscale of the SF-36 in patients with bilateral symptoms
Table 2. Correlation Between the QOL and Clinical Evaluation Score and Age, Body Mass Index, and Radiographic Evaluations.a
Abbreviations: AAOS, American Academy of Orthopaedic Surgeons; HV, hallux valgus; IM, intermetatarsal; JSSF, Japanese Society for Surgery of the
Foot Hallux Scale; MCS, mental component summary score; PCS, physical component summary score; QOL, quality of life; SF-36, 36-item Short Form
Health Survey; VAS, visual analog scale for pain.
a
Correlations were assessed using Spearman rank correlation coefficient. The QOL evaluation item and clinical evaluation scores were compared
between patients with bilateral versus unilateral symptoms, and patients with versus without lesser toe pain or pain in other parts of the body using
the Wilcoxon signed-rank test. Values indicate the correlation coefficient and P value.
*P < .05, **P < .01.
was significantly worse than that of patients with unilateral experienced by patients undergoing hallux valgus surgery.
symptoms (Table 2). Saro et al also investigated the QOL for preoperative women
with HV using the SF-36.28 They found that only the bodily
pain SF-36 subscale was significantly lower than that of the
Discussion general Swedish population. Conversely, Menz et al sur-
We assessed the QOL of subjects with untreated and symp- veyed the 2831 participants of the North Staffordshire
tomatic HV who visited outpatient clinics. Most of the SF-36 Osteoarthritis Project.22 Although their study population
values, in particular physical functions for HV subjects, were included both symptomatic and asymptomatic subjects, they
significantly lower than those of the general population as found that all SF-36 values for people with HV were signifi-
well as the population in the 60s. Furthermore, we showed cantly lower than those for people without HV. The results of
that all QOL evaluation items and clinical evaluations were our study mirrored those of Menz et al,22 but differed from
not significantly or negligibly correlated with age, body mass the results of Thordarson et al32 and Saro et al.28 The discrep-
index, or radiographic measurements, and were not influ- ancy may result from the difference in subject backgrounds.
enced by pain in the lesser toes or other parts of the body. Specifically, patients with painful and untreated HV had
In this study, standardized values of all SF-36 subscales impaired QOL, as presented in this study, whereas the
and physical component summary scores for untreated and selected patients who hope to undergo HV surgery may have
symptomatic HV subjects were significantly lower than those high functional demands, as Thordarson et al showed.32
of the general population. Thordarson et al investigated the We showed that the severity of the hallux deformity, includ-
QOL of HV patients undergoing corrective surgery using the ing the HV angle and intermetatarsal angle, was not correlated
SF-36.32 The authors showed that the mental subscale scores, or was negligibly correlated with any of the QOL scores or
such as vitality, social function, role-emotional, mental VAS for pain. The HV angle was significantly correlated with
health, and general health, were equal to or higher than those the JSSF score; however, this finding was because the JSSF
of the general American population. They suggested that the includes an item of 15 points to assess the deformity of the hal-
results reflected the higher functional demands of patients lux. Similarly, Thordarson et al found no significant differ-
who hope to undergo corrective surgery and concluded that ences in any QOL measurement item among 3 patient groups
bodily pain appears to be a sensitive measure of problems with mild, moderate, and severe deformities.32 Nishimura et al
performed a cohort study of Miyagawa village in Japan.24 different symptoms in HV patients18; thus the results of this
They also reported that the EQ-5D scores in people with severe study may not be extrapolated to HV subjects in other coun-
HV deformity were not significantly lower than the scores of tries. However, Western-style shoes have been standard
people with moderate deformity. In contrast, Menz et al footwear in Japan for several decades, and the number of
showed a significant negative correlation between the HV HV cases has markedly increased in the late 20th century.
angle and all SF-36 subscales in a large population-based Fourth, we examined the factors associated with the QOL of
study.22 However, the correlations in their studies were weak, HV patients within the symptomatic HV patient group. A
and may not be clinically significant. Additionally, their cohort comparison with asymptomatic HV patients as a control
included subjects without HV and subjects with asymptomatic would have provided additional information on the associ-
HV, thus the results may not be applicable to clinical practice, ated factors. Fifth, we used the JSSF scale for our clinical
where patients have symptomatic HV. The reason for the lack evaluation. Although the JSSF scale is a validated outcome
of correlation between the QOL measures and the severity of measure, it is mainly used in Japan and is not widely used in
hallux deformity in our study is unclear. One possible explana- other countries. However, we performed comprehensive
tion is that the severity of deformity has no impact on the QOL evaluations, including the SF-36, AAOS score, and
symptoms. Nevertheless, once it is symptomatic, it affects the VAS for pain. Therefore, the results of this study could be
QOL regardless of the severity. widely applicable for comparison with other studies. Finally,
In this study, the degree of dislocation of the second the body mass indexes of the patients were calculated from
metatarsophalangeal joint did not affect the QOL of patients the self-reported weight and height. Patients tend to underes-
with symptomatic HV. Except for the mental component timate their weight,6 and thus the calculated body mass
summary score, none of the SF-36 subscales or physical index might have been lower than the actual value.
component summary scores of the subjects with a disloca-
tion of grade 0 (HV alone) were significantly different from Conclusion
the subjects with dislocations of grade 1 or 2/3. Lesser toe
pain also did not affect the QOL of the HV subjects. In con- All subscales and physical component summary scores of
trast, Gines-Cespedosa et al found that preoperative HV the SF-36 for untreated HV patients were significantly
patients with metatarsalgia and a deformity of the lesser toe lower than those of the general population. The QOL and
had significantly worse physical function, role-physical, clinical evaluations were not significantly or negligibly cor-
bodily pain, role-emotional, mental health, and mental related with age, body mass index, deformity of the hallux
component summary scores of the SF-36 compared to HV and second toe, lesser toe pain, or pain in other parts of the
patients without these conditions.14 The discrepancy body. Surgical decision making should not be based on the
between our study and Gines-Cespedosa et al may be, severity of the deformity alone, but rather the patient’s QOL
again, due to differences in the patient backgrounds. should also be carefully assessed.
This study has several limitations. First, the sample size
of the subjects was relatively small compared with previous Declaration of Conflicting Interests
population-based studies.3,22,24 In this study, our focus was The authors declared no potential conflicts of interest with respect
on subjects who have painful feet and require treatment in to the research, authorship, and/or publication of this article.
orthopedic clinics. Additionally, we carefully excluded sub-
jects who had received prior treatment, because previous Funding
treatments might have affected the QOL measures. The authors received no financial support for the research, author-
Consequently, 116 subjects were enrolled in this study, ship, and/or publication of this article.
which is comparable to other studies in which symptomatic
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