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Re exology treatment relieves symptoms of multiple sclerosis: a
randomized controlled study
I Siev-Ner
1
, D Gamus
1,
*, L Lerner-Geva
2
and A Achiron
3
1
Complementary Medicine Clinic, Department of Orthopedic Rehabilitation;
2
Gertner Institute for Epidemiology and
Health Policy Research;
3
Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, I srael
Objective: To evaluate the effect of refle xol o gy on symptoms o f multiple sclerosis (MS) in a randomized, sham-contro ll ed clinical trial.
Methods: Seventy-one MS patients w ere randomized to either study or contro l group, to receive an 11-week treatment. Reflexology
treatment included manual pressure on specific points in the feet and m assage of the calf area. The co ntro l gro up received nonspecific
massage of the calf area. The intensity of paresthesi as, urinary symptoms, muscle strength and spasticity was assessed in a masked fashion
at the beginning o f the study, after 1.5 months of treatment, end of study and at three months of follow-up. Results: Fifty-three patients
completed this study. Significant impro vement in the differences in mean scores of paresthesias (P
¾/
0.01), urinar y symptoms (P
¾/
0.03)
and spasticity (P
¾/
0.03) was detected in the re flexology gro up. Improvem ent wit h bo rder line significance was observed in the d ifferences
in mean scores of muscle stre ngth between the reflexo logy group and the contro ls (P
¾/
0.06). The improvement in the intensity of
paresthesias remained significant at three months o f follow-u p (P
¾/
0.04). Conclusions: Specific reflexology treatment was o f benefit i n
alleviating motor, senso ry and urinar y symptoms in MS patients
Multiple Sclerosis
(2003) 9,
356¡/361
Key words:
co mplementary medicine; multiple sclero sis; pare sthesia; re exo logy; spasticity
Introductio n
Multiple sclerosis (MS) is the commonest human demye-
linating disease with a general prevalence rate of 50
¡/
100
per 100 000 population in northern Anglo-Saxon commu-
nities. This autoimmune disorder is characterized by
repeated occurrence of de myelinating lesions within the
central nervous system and, similarly to other chronic
illnesses, can profoundly affect qualit y of life and activ-
ities of daily living. Among major symptoms caused by
MS are spasticity, paresthesias and bladder dys-
function.
1
¡
3
Medical treatment of MS patients has em-
phasized both pharmacological and rehabilitation
approaches.
3
¡
5
New pharmacotherapeutic a gents are targeted mainly to
reduce demyelination by modifying the immune response
(beta interferons), to enhance remyelination (growth fac-
tors) and to improve conduction in demyelinated fibres.
3,6
Unfortunately, some current and investigational therapies
are associated with considerable adverse effects, or are of
limited efficacy.
2,7
MS patients, similarly to patients with other chronic
diseases, frequently apply to complementary (‘alterna-
tive’) therapies,
8
yet the data concerning their effective-
ness, safety or costs is limited.
Reflexology is also known as ‘zone ther apy’ and in-
volves manual stimulation of reflex points on the feet that
correspond somatotopicall y to specific areas and organs of
the body. It is based on the theory that all organs are
represented by various points on the feet, forming a map of
the whole body, and that massaging specific areas of feet
can affect corresponding target organs. Although the
technique was already well known to ancient Chinese
physicians, it was introduced to the west by Dr W
Fitzgerald in 1913. Since then, reflexology be came one
of the most popular treatment modalities in complemen-
tary medicine.
9,10
However, only one randomized con-
trolled study was performed until now, demonstrating that
specific reflexology treatment is superior to nonspecific
massage in treating symptoms of premenstrual syn-
drome.
11
Our clinical experience indicated that paresthesias and
spasticity in MS and in patients with other disorder s
could be alleviated by reflexology.
We therefore designed a prospect ive, randomized,
sham-controlled clinical trial to compare the effect of
reflexolog y treatment versus non-specific massage on MS
patients with spasticity, sensory and urinary symptoms.
Meth o d s
Planned study population
All patients who were treated at the MS Center, Sheba
Medical Center, Tel Hashomer, Israel.
*Correspondence: Dorit Gamus, Complementary Medicine
Clinic, Department of Orthopedic Rehabilitation, Sheba
Medical Center, Tel-Hashomer, 52621, Israel.
E-mail: dgamus@sheba.health.gov.il
Received 23 November 2002; revised 24 March 2003;
accepted 25 March 2003
Multiple Sclerosis 2003; 9: 356¡/361
www.multiplesclerosisjournal.com
#
Arnold 2003
10.1191/1352458503ms925oa
Inclusion criteria Patients with a definite diagnosis of MS,
suffering from paresthesias and/or spasticit y, or both.
Exclusion criteria Exc lusion criteria were:
. acute relapse of the disea se three months preceding or
during the st udy period;
. recent onset or discontinuation (less than one month)
of physiothe rapy or any other manual treatment (e.g.,
massage therapy).
This criterion was applied in order to eliminate change s
in the muscle tone unrelated to reflexology treatment or to
the basic disease.
For the same reason, patient s were required to report
about any change in their medical treatment during the
study.
Protoco l
Planned interventions
Patients were randomized by block randomization. Every
patient that was found to be eligible to the study was
assigned a s ealed envelope with the group allocation
(study/control). Each patient received 11 weeks of treat-
ment once a week, for 45 minutes. The study was
performed at the Clinic of Complementary Medicine,
Sheba Medical Center, Tel-Hashomer, Israel, with the
participation of 36 reflexologists. Each reflexologist trea-
ted one study and one control patient. Patients in the
study group received full reflexology treatment which
included manual pressure on specific points of foot soles
and massage of the calf area, while patients in the control
group re ceived sham treatment of nonspecific massage of
the calf, providing control for touch therapy and general
relaxation. The patients in both groups were therefore
exposed to the same therapists. All patients received e qual
number and duration of treatment sessions. The treatment
protocol was designed and supervised by two senior
reflexolog ists.
Patients were informed that they are going to receive
reflexolog y treatment targeted mainly either to the sole
(study) or to the ca lf area (control s), while the efficacy of
each is yet to be determined. The reflexololgists were
instructed not to discuss the efficacy of eit her treatment
with the patients.
Clinical assessment was performed in a masked fashion
before, at the onset, after six weeks of treatment, upon
completion of the treatment period and after additional
three months.
O utcome measures
a) The intensity of pa resthesias was assessed by the
Visual Analogue Scale (VAS). As the majority of the
patients suffered from paresthesias in several loca-
tions, the intensity, location and duration (hours/
week) of each paresthesia were recorded. Evaluation
of VAS at eac h time point of the follow- up included
the information concerning the loc ations reported
prior to the commencement of the trial, as well as
inquiry about appearance of additional locations. An
average was taken for each patient’s scores a t each
time point of the study. This approach was applied in
order to avoid an overl oad of information.
b) Urinary symptoms were not a part of primary inclu-
sion criteria, but were assessed in all patients by the
American Urological Association ( AUA) symptom
score.
12
c) Proximal lower extremities muscles (iliopsoas, quad-
riceps, hamstrings and adductor muscles) of the
patients were eval uated as follows: muscle tone-by
Ashworth score, and muscle strength-by British
Medical Research Council (BMRC) scale.
14
The eva-
luations were performed by the same physiotherapist
in a masked fashion, under supervision of a senior
neurologist. Since the same muscle groups were
measured in all patients, we evaluated an average
score for each patient at each time point of the study.
Sample size calc ulation
In orde r to evaluate the possible effect of reflexology
treatment on MS patients (which was not yet reported) an
open trial was conducted.
Twenty MS patients suffering from paresthesias were
recruited and trea ted for a period of 1.5 months. The
intensity of paresthesias was evaluated prior to treatment
and at the end of the treatment period. An improvement
was note d in seven of 20 patients.
Sample size for the current clinical trial was calculated
based on expected improvement of 30% exposed to
reflexolog y treatment and 5% among the controls. A ratio
of 1:1 (exposed: controls) was chosen with a
¾/
0.05 and 1-
b
¾/
80%.
13
The study population was calculated as 70
patients, equall y allocated to treatment and control
groups.
Data analysis
Statistical analysis was performed using SPSS-PC soft-
ware for windows (Version 8.0, SPSS, Chicago, 1997).
Probability of B
/
0.05 was considered statistically signifi-
cant. Due to the small number of observations in both the
study and control groups, normal distribution was not
evident. Therefore, nonparametric analysis was per-
formed.
Two related samples Wilcoxon signed Ranks test was
performed to calculate for significanc e of differences
within the study and the control groups at various time
points of the trial. Mann
¡/
Whitney U-test for two inde-
pendent samples was performed for the significance of
differences between the study and the control groups.
Trends over time were eva luated betwee n the differ-
ences from base line values at six weeks following com-
mencement of the trial, at completion of the trial and at
three months of follow-up.
Only patients who completed the trial were analysed.
The local ethical committ ee and Israeli Ministry of
Health approved t he study and written informed consent
was obta ined from all patients.
Reflexology in treatment of multiple sclerosis
I Siev-Ner et al.
357
Multiple Sclerosis
Results
Out of 71 patients recruited, 53 (75%) completed this
study: 27 patients in the study and 26 in the control group.
The demographic variables of the patients are demon-
strated in Table 1. There was no statistically significant
difference between the study a nd the control group in any
of the fol lowing parameters: age, sex, duration of the
disease, or in the initi al severity of the evaluated symp-
toms.
There were no statistically significant differences be-
tween the intention-to-treat patients and the completers,
as well as between the dropouts and the c ompleters.
The outcome measures of clinical symptoms: (I) mean
intensity of parasthesias, evaluated by VAS score; (II)
urinary symptoms, evaluated by AUA scale; (III) muscle
strength, presented as sum of proximal muscle group on
BMRC scale, and (IV) spastisity, assessed by Ashworth
scale, are pre sented in Table 2.
Not all patient s suffered from the same or all symptoms.
No statistically significant di fferences in the intensity of
symptoms was obse rved at baseline.
Table 3 presents the outcome me asures for both the
reflexolog y and the control groups before and after the
intervention. Statistically significant improvement for
each eva luated outcome measure was demonstrated in
the reflexology group, while none of them appeared to be
significant in the control group. Comparison of the out-
come mea sures between the two groups (reflexology and
control) demonstrated statistically significant differences
for scores of paresthesias, urinary symptoms and spasti-
city, while muscle strength revealed only borderline
improvement (P
¾/
0.06).
The differences from baseline of both groups were
compared over time: beginning of the study, after six
weeks of treatment, end of treatment, and after additional
three months of follow-up (Table 4). The improvement in
the intensity of paresthe sia remained significant at three
months of follow-up (P
¾/
0.04).
An attempt was made to locate the dropouts and invit e
them for the follow-up. However, the patients refused to
do so.
All patients (in both the study and control groups)
received physiotherapy prior to the trial and continued to
do so throughout the follow-up period.
During the treatment and the follow-up period no
changes in medication or physiotherapy wer e recorded,
except for the patients who developed an acute attack of
the disease or infectious diseases and thus were excluded
from the study.
Discussion
In the present randomized controlled trial we have
demonstrated significant decreases in intensity and dura-
tion of paresthesia and of urinary symptoms as well as a
significant improvement in spasticity, and an improve-
ment of borderline significance in muscle strength in the
reflexolog y group by the end of the treatment period. No
improvement could be observed in the control group. The
improvement in both spas ticity and in muscle strength is
quite remarkable, as some of the pharmacologi cal ag ents
for treatment of spasticity are associated with muscle
weakness.
14,15
Critics of complementary therapies often present the
argument that placebo effects comprise most of their
therapeutic effect, partly due to patient’s expectations,
the compas sion of the therapist and to the relaxing
atmosphere of private clinics.
16
In order to overcome
this obstac le, we performed all treatments in the f acility
of a hospital clinic. A design of control treatment has been
also given a careful consideration. We c onsidered the
difficulty presented to reflexologists to avoid touching
specific points of the feet. Therefore, a nonspecific
massage of the calf (rather than of the feet area) was
chosen as sham therapy, providing control for touch
therapy and general relaxation. Anot her point in evalua-
tion of trials of c omplementary therapies is related to the
fact that the skills of the prac titioners are not uniform and
thus positive results might not be reproducible. This point
was addr essed in this study by enrolling 36 reflexologists
that provided both verum and control tre atment under
supervision of two experienced reflexologists.
Table 1 Demographic characteristics of the patients
Variable Reflexology (n ¾/27)
(mean9/SD)
Control (n¾/26)
(mean9/SD)
Sex (female/m ale) 17/10 17/9
Age 46.29/9.3 49.29/11.0
Duration of the disease 11.99/9.2 13.49/9.1
Intention to treat 36 35
Completed the trial 27 (75.0%) 26 (74.3%)
Reasons for discontinuation:
Acute attack 3 (8.3%) 3 (8.6%)
Hospitalization unrelated to MS 1 (2.8%) 1 (3.0%)
Incon
v
enience of time table 3 (8.3%) 2 (5.7%)
Transportation difficulties 2 (5.6%) 3 (8.6%)
The data presents demographic characteristics of the patients within the two groups after randomization procedure (in tention-to-treat
and completers): age, sex, dura tion of the disease, the initial se
v
erity of the e
v
aluated symptoms and the reasons for discontinuation of
treatment.
Reflexology in treatment of multiple sclerosis
I Siev-Ner et al.
358
Multiple Sclerosis
An additional difficulty inherent to such study pertains
to the treatment modality: reflexol ogy similarly to other
complementary therapies, tre ats patients on individual
basis and not according to medical diagnosis. Evaluation
of the effect of massaging of fixed points on the fe et is
therefore not always relevant or possible. For that reas on,
we evaluated the effect of reflexology (as an intervention
procedure) on outcome measures rather than investigating
the effect of specific pressure points on the feet.
Previously reported study that examined the effect of
reflexolog y on MS, demonstra ted positive results (sub-
jective clinical improvement in 45% of the patients),
though contained several methodological fla ws such as:
i) no randomization was performed to treatment and
control groups; ii) the control group receive d no interven-
tion at all.
17
Another randomized study that tested t he effect of
reflexolog y treatment in women who underwent an
abdominal operation, demonstrated positive e ffect of foot
reflexolog y on voiding during post-operative period.
18
The effect of neural therapy (a form of acupuncture) was
also evaluated in MS patients in a randomized controlled
study, which demonstrated short and long-term beneficial
effects on functional assessments of the patients.
19
The mechanism by which reflexology (or acupuncture)
may affect sensory, motor and urinary symptoms in MS in
not fully understood. A study that tested the hypothesis
whether reflexology is associated with specific target
organs, demonst rated that massaging the kidney area
was f ollowed by a n increase of kidney blood perfusi on.
20
It is also possible that similarly to the effect of acupunc-
ture,
21
reflexolog y may influence the release of endogen-
ous opiates that have important role in reduction of pain
and reg ulation of immune functions.
21,22
Both of these
techniques are based on traditional Chinese philosophy of
healing. While acupuncturist uses specific points along
body meridians, reflexologist applies pressure upon end
points of these meridians on the feet.
Although the effect of stress on the immune system is
well acknowledged,
22
patients in both groups reported
that the treatment was pleasant and relaxing, and that they
would recommend it to other patients.
A search for new treatment modalities aimed to improve
disturbing symptoms in MS continues. It is of interest to
Table 2 Characteriza tion of symptoms at ba seline
Symptom Study Group (n¾/27) Controls (n ¾/26)
Number of patients Intensity of symptoms Number of patients Intensity of symptoms
Paresthesia 23 5.629/1.5 20 4.729/2.2
Urinary symptoms 21 4.079/6.4 18 16.259/7.6
Muscle strength 27 15.339/5.4 26 13.779/5.2
Spasticity 11 5.099/4.5 16 3.259/2.1
The data represents distribution and characterization of symptoms at baseline, since not all patie nts suffered from the same symptoms.
Table 3 Comparison of outcome measures at entry and upon completion of the study in p atients treated with reexology and non-
specic massage (control)
Outcome measures Reflexology P* Control P* P**
I. Inte nsity of paresthesia (mean9/SD)
No. of patients 23 20
Before treatment 5.629/1.5 4.719/2.2
Post trea tment 4.129/2.3 4.889/2.2
Mean difference ¼/1.499/2.1 0.002 0.169/2.1 0.736 0.01
II. Urina ry symptoms (mean9/SD)
No. of patients 21 18
Before treatment 14.079/6.4 16.259/7.6
Post trea tment 9.909/4.9 16.089/8.5
Mean difference ¼/4.179/6.32 0.013 ¼/0.349/4.43 0.697 0.03
III. Mu scle strength (mean9/SD)
No. of patients 27 26
Before treatment 15.339/5.4 13.779/5.2
Post trea tment 16.239/5.2 13.999/5.9
Mean difference 0.969/1.3 0.002 ¼/0.39/1.7 0.646 0.06
IV. Spasticity (mean9/SD)
No. of patients 11 16
Before treatment 5.099/4.5 3.259/2.1
Post trea tment 3.009/4.2 3.409/2.2
Mean difference ¼/2.099/3.01 0.044 0.29/1.72 0.726 0.03
No. of patients in each group of symptoms indicate the number of patients who presented with particular symptoms.
P * Two related samples Wilcoxon Signed Ranks test.
P ** Mann¡/Whitney U-test for two independent samples.
Reflexology in treatment of multiple sclerosis
I Siev-Ner et al.
359
Multiple Sclerosis
note such positive effect of singl e intervention on a broad
range of symptoms. This may possibly stem from the
holistic approach of the reflexology (similarly to other
complementary therapies), that treats the whole person
rather than specific symptoms.
To the best of our knowledge, this is the first rando-
mized controlled s tudy of reflexology treatment i n MS
patients. We conclude that the treatment was safe, as the
patients reported no adverse effects. Moreover, reflexology
positively affected muscle strength and tonus and also
reduced sens ory and urinary symptoms.
Further clinical and laboratory s tudies are needed to
validate these results and to understand the mechanisms
by which reflexology improves symptoms secondary to
MS.
A ckno wledgements
Authors are gra teful to Mrs. D. Sha’ked for designing and
supervising of reexolgy treatment; to Mrs. D. Nitzani for
evaluation of musc le tone and muscle strength and to Mr.
S. Zaidel for recruitment of graduate reexologists from
the School of Human Ecology, who participated in this
study, and for his assista nce in supervising the treatment
protocol.
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measures
Study Control P-Value*
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Mean difference at follow-up ¼/1.679/3.2 0.159/2.03 0.06
NS ¾/non significant.
P -
v
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