Neurological Research

A Journal of Progress in Neurosurgery, Neurology and Neuro Sciences

ISSN: 0161-6412 (Print) 1743-1328 (Online) Journal homepage: http://www.tandfonline.com/loi/yner20

Comparison of the effect of baclofen and

transcutaneous electrical nerve stimulation for
the treatment of spasticity in multiple sclerosis

Vahid Shaygannejad, Mohsen Janghorbani, Atefeh Vaezi, Sepehr Haghighi,

Khodayar Golabchi & Mojtaba Heshmatipour

To cite this article: Vahid Shaygannejad, Mohsen Janghorbani, Atefeh Vaezi, Sepehr Haghighi,
Khodayar Golabchi & Mojtaba Heshmatipour (2013) Comparison of the effect of baclofen and
transcutaneous electrical nerve stimulation for the treatment of spasticity in multiple sclerosis,
Neurological Research, 35:6, 636-641

To link to this article: http://dx.doi.org/10.1179/1743132813Y.0000000200

Published online: 05 Dec 2013.

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 Comparison of the effect of baclofen and
transcutaneous electrical nerve stimulation for
the treatment of spasticity in multiple
sclerosis
Vahid Shaygannejad1, Mohsen Janghorbani2, Atefeh Vaezi1, Sepehr Haghighi1,
Khodayar Golabchi1, Mojtaba Heshmatipour3
1
Department of Neurology, Medical School, Isfahan University of Medical Sciences, Iran, 2Department of
Epidemiology and Biostatistics, School of Public Health, Isfahan University of Medical Sciences, Iran, 3School
of Rehabilitation, Isfahan University of Medical Sciences, Iran

Objective: The aim of this study was to compare the relative efficacy of baclofen and self-applied
Downloaded by [Tulane University] at 11:41 18 April 2016

transcutaneous electrical nerve stimulation (TENS) for the treatment of spasticity in the lower extremities in
multiple sclerosis (MS).
Methods: A randomized controlled clinical trial was conducted from September 2010 to June 2011. Fifty-
two patients with MS presenting muscle spasm in the leg at 20–50 years of age were randomly allocated to
receive a four-week treatment course of either baclofen (10 mg twice daily, increasing over three weeks to
25 mg) or self-applied TENS. Response to treatment was assessed at four weeks after commencement of
the intervention by modified Ashworth scale (MAS).
Results: Spasticity decreased in both groups. Of the 26 people treated with TENS, the mean (standard
deviation (SD)) MAS decreased from 1.77 (0.29) at baseline to 0.73 (0.70) at the four-week follow-up (P ,
0.001). Correspondingly, in the 26 people treated with baclofen, the mean (SD) MAS decreased from 1.73
(0.38) to 1.15 (0.63) (P , 0.001). The mean difference in MAS score at the four-week follow-up was
significantly lower in the TENS group than the baclofen group (mean difference 20.42; 95% CI, 20.79,
20.05; P , 0.05).
Discussion: This study demonstrates that both baclofen and TENS can be effective in reducing MS-related
spasticity. The mean MAS score was significantly lower in the TENS group. However given the side-effect
profile of baclofen, TENS may have some benefits over baclofen.
Keywords: Baclofen, Efficacy, Transcutaneous electrical nerve stimulation, Muscle spasticity, Modified Ashworth scale, Multiple sclerosis, Clinical trial

Introduction improve care and treatment outcomes; therefore the

Spasticity, a motor disorder characterized by a
velocity-dependent increase in tonic stretch reflexes
that results from abnormal intraspinal processing of
primary afferent input,1 is a common and disabling
symptom in multiple sclerosis (MS), with a preva-
lence of more than 60%.2 It is often associated with
significant disability and impaired quality of life,
adversely affecting daily activity and work-related
productivity for many patients.2 The mechanisms
underlying spasticity in MS are still poorly under-
stood. Management of spasticity aims to prevent and
minimize provocative factors, reduce spasticity, and
prevent its consequences. Spasticity management can
Correspondence to: M. Janghorbani, Department of Epidemiology and
Biostatistics, School of Public Health, Isfahan University of Medical
Sciences, Isfahan, Iran. Email: janghorbani@hlth.mui.ac.ir
management of spasticity in patients with MS is an
important goal.
The oral medications used most frequently for
spasticity management, baclofen, tizanidine, dantro-
lene, or diazepam, may cause considerable side effects
and have only a partial effect on spasticity.3–6 Of
these agents, baclofen is probably the most common
drug used for the management of spasticity in people
with MS.5 Unfortunately, many people with MS are
unable to continue with long term oral medication,
and as a consequence do not achieve adequate
control of spasticity, or are unable to tolerate the
medication due to side effects.3,4 There is, therefore, a
need to explore the effectiveness of alternative
options for the management of spasticity in people
with MS for whom the use of oral medications is

ß W. S. Maney & Son Ltd 2013

636 DOI 10.1179/1743132813Y.0000000200 Neurological Research 2013 VOL . 35 NO . 6

either ineffective or cause significant side effects.
Transcutaneous electrical nerve stimulation (TENS)
is one such non-pharmacological treatment option. It
is a non-invasive treatment, commonly used to treat
many pain syndromes and conditions, and has been
demonstrated to be an effective treatment for pain in
a significant proportion of patients.7–9 To date, there
is limited evidence regarding the effectiveness of
TENS in treating spasticity; a few small studies which
have addressed the use of TENS for treatment of
spasticity in people with MS suggest that it may have
a beneficial antispasmodic effect in this condition.10,11
For example, significant reduction in spasticity in the
plantar flexor muscles of the ankle after four weeks
of TENS treatment was reported in 10 clinically
defined MS patients with mild to moderate spasticity
by Armutlu et al.,11 whereas the Miller et al.10
study with 32 MS patients who were randomized into
two groups to compare two weeks of 60 minutes and
Downloaded by [Tulane University] at 11:41 18 April 2016
8 hours daily TENS application, suggested that,
whist TENS does not appear to be effective in
reducing spasticity, longer application may be useful
in treating patients with muscle spasm. No studies are
available comparing baclofen with TENS for the
treatment of MS related spasticity.
In the present randomized trial, we compared the
effects of baclofen and self-applied TENS to inves-
tigate their relative efficacy in the treatment of
spasticity of people with MS. The prior hypothesis
was that the effect of baclofen and self-applied TENS
is different in the treatment of MS-related spasticity.
Patients and Methods
This is a randomized clinical trial to compare the
efficacy of TENS and baclofen on spasticity in MS
patients.
Patients
The study sample comprised of 68 consecutive
patients with MS who sought treatment for muscle
spasm of the lower extremities at our neurology
outpatient clinics of Isfahan University of Medical
Sciences, Iran, between September 2010 and June
2011. Entry criteria included men and women aged
15–50 years with a clinical or laboratory-supported
diagnosis of definite MS12 documented by a neurol-
ogist and a willingness to continue current interven-
tions for the duration of the study. Subjects had to be
ambulatory, with a Kurtzke Expanded Disability
Status Scale (EDSS)13 score of (6.0 for at least one
year of the natural course of the disease, and with
physician-diagnosed muscle spasm in their lower
extremities, with a score of (3 in the modified
Ashworth scale (MAS)14. People were excluded if
they were within one month of relapse either
preceding or during the trial period; met any contra-
indications to TENS; had a history of analgesic
Shaygannejad et al. Baclofen vs TENS in MS-related spasticity
abuse; evidence of any major coexisting medical illness
(e.g. cardiac, endocrinological, hematological, hepatic,
renal, pulmonary disease, active malignancy, auto-
immune diseases, or other chronic diseases); had a
history of uncontrolled seizure or suicidal tendency or
an episode of severe depression within the period of
three months prior to enrolment; lactation and
pregnancy as determined by history, physical exam-
ination, and screening blood tests. All female partici-
pants of childbearing potential had to practice a
clinically accepted method of contraception; and
individuals were required to discontinue muscle re-
laxants other than baclofen (e.g. Tizanidine, diaze-
pam, dantrolene) for the duration of the study. Tenets
of the current version of the Declaration of Helsinki
were followed, the study protocol was approved by the
Institutional Review Board of Isfahan University of
Medical Sciences, Iran, and the nature of the trial and
possible side effects of the interventions were explained
to all participants. After a detailed discussion with the
neurologist, patients made a final decision and each
patient signed an informed consent.
Randomization scheme
Ten of the 68 patients attending the initial assessment
were excluded either because of declining to partici-
pate or failing to meet the inclusion criteria. The
remaining 58 patients who met the inclusion criteria
were reassessed for eligibility immediately before
entering the trial, and were subsequently enrolled in
the trial. Before the commencement of the interven-
tion, a pre-treatment evaluation was undertaken on
all 58 participants. This comprised obtaining demo-
graphic data, completing a neurological and medical
history, and physical examination. After this, all
participants were assigned randomly and equally to
one of the two treatment groups (Fig. 1) according to
a pre-existing list produced by a computer program
that differed from a random number generator only
in that it assigned equal numbers of participants into
each treatment group.
Interventions
The pharmacological treatment group received baclo-
fen (registered trade name of Zahravi Pharmaceuti-
cal Mfg. Co., Tehran, Iran). The dose escalation
schedule for baclofen was 10 mg twice daily for one
week, then 25 mg twice daily for the next three weeks.
Treatment side effects (e.g. drowsiness, dizziness,
ataxia, weakness, headache, insomnia, nausea, and
vomiting) were examined by the study physician.
The non-pharmacological treatment group received
self-applied TENS. A conventional portable TENS
unit (Med 400A, Arman Pouya Co., Iran) was used in
the symptomatic area of the lower extremities, which
was marked at the start of treatment. In each case, the
current treatment was applied to the participant’s
Neurological Research 2013 VOL . 35 NO . 6 637
 Shaygannejad et al. Baclofen vs TENS in MS-related spasticity
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Figure 1 Design of the study.
symptomatic area with four integrated self-adhering
464 cm electrodes (BaByLiss, France). Before the
electrode placement, the skin was cleansed with alcohol
swabs in order to reduce the electrical resistance of the
epidermis.15 The electrodes were positioned over the
middle of the gastroc-soleus muscle and the other one
at the bottom of the lateral malleolus. The current
frequency was set at 100 Hz, with pulse width set at
250 ms, and delivered in a rectangular monophasic
waveform. Stimulus strength was set below the motor
threshold at an intensity level required to produce a
tingling sensation in the stimulated area without
muscle twitch or pain. Participants were given verbal
and written instructions, an emergency telephone
number, and a demonstration of the treatment to
which they had been allocated. Those in the TENS
group were instructed to apply the treatment for 20–
30 minutes, for four weeks, and at any time an episode
of muscle spasm occurred. Additionally, all partici-
pants were instructed to apply the treatment at a
‘strong but comfortable’ intensity, or set it to the
midpoint of the dial if no sensation was perceived.
To overcome accommodation, all participants were
instructed that if the level of sensation decreased, to
increase the intensity to return it to the original level.
At the conclusion of each treatment sessions partici-
pants were advised to remove all electrodes and
examine the electrode sites for any skin irritation.
Assessment
Patients were evaluated at four weeks after the start
of the therapy by the use of a structured interview, a
638 Neurological Research 2013 VOL . 35 NO .
brief physical assessment, and MAS.14 The MAS was
used for evaluation of spasticity, whereby a score of 0
characterizes normal tone and 5 indicates that the
affected part is rigid in flexion or extension.
The structured interview was undertaken by one
physician (AV) who evaluated the presence of muscle
spasms, the development of side effects of the
interventions, and compliance of the person in admin-
istering the intervention. The interview focused on the
presence of chronic and episodic spasms, localization,
characteristics, intensity, and consequence of the
symptoms as well as use of medication. In order to
include clinically meaningful spasms and to limit
potential errors because of memory, the assessment
of intensity and consequence of the symptoms focused
on symptoms experienced during the final four weeks.
Statistical analysis
The sample size was calculated when the study was
designed and was based on the comparison of two
means. We estimated that a 0.4-point mean difference
in MAS may be clinically significant. We calculated
that 25 patients per treatment group would be
required to provide the study with approximately
an 80% power to detect (with a two-sided alpha of
0.05) the mean difference in MAS between baclofen
and TENS groups assuming a standard deviation
(SD) of 0.5.
Comparison between groups was made using
Mann–Whitney U tests. Group comparisons were
undertaken using Wilcoxon tests, to determine differ-
ences between baseline and four-week assessment
6
 Shaygannejad et al. Baclofen vs TENS in MS-related spasticity

scores. Comparisons between proportions were under-
taken using chi-square or Fisher’s exact test. Right and
left legs were analyzed separately to fulfill the
assumption of independence. Results are expressed
as mean (SD) and P , 0.05 was considered statistically
significant. All statistical tests were two-sided. The
analyses were undertaken using SPSS for Windows
(SPSS Inc., Chicago, IL, USA).
Results
The 58 patients who met the entry criteria and were
enrolled into the study had a mean age (SD, range) of
39.2 years (8.5, 20–50). Four participants from the
baclofen group dropped out due to adverse effects
(three could not tolerate baclofen because of severe
drowsiness and one had severe dizziness in addition
to gastrointestinal (GI) side effects). In all cases, the
side effects soon disappeared after cessation of
therapy, suggesting that the symptoms were unlikely
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progressive; mean (SD) duration of MS diagnosis 6.3
(4.1) years, range 1–19 years)). The two treatment
groups were generally well matched at baseline with
regard to age, gender, and duration of MS diagnosis,
EDSS, and MAS. The mean age (SD) of TENS and
baclofen groups were 39.5 (9.3) and 38.9 (7.8) years,
respectively. The mean (SD) EDSS at the start of
treatment with TENS and baclofen was 2.8 (1.4) and
2.6 (1.3), respectively. The mean (SD) spasticity
measured by MAS in the lower extremities at the start
of treatment with TENS and baclofen was 1.8 (0.29)
and 1.7 (0.38), respectively. There was no statistically
significant difference between them (Table 1).
Changes of MAS before and for weeks after
receiving TENS or baclofen are shown in Table 2. In
both groups MAS significantly decreased. In the both
groups of MS patients the MAS improved by a mean
(SD) of 0.8 (0.6) point four weeks after receiving
baclofen or TENS. The average MAS decreased from

to have been manifestations of the disease. Two
participant from the TENS group dropped out due to
difficulties in keeping the assessment appointments.
Participant compliance was good with 52 of the
participants who completed the treatment being
available for follow-up assessments (38 relapsing–
remitting, 13 secondary progressive, and one primary
baseline by 1.04 points (95% CI; 0.81, 1.28) in the
TENS group, compared to a reduction of 0.58 points
(95% CI; 0.37, 0.78) in the baclofen group. The mean
difference in MAS score at the four-week follow-up
was significantly lower in the TENS group than the
baclofen group (mean difference 20.42; 95% CI,
20.79, 20.05; P , 0.05).

Table 1 Characteristics of people with multiple sclerosis (MS) by treatment group at baseline

Treatment group

Characteristics TENS (n526) Mean (SD) Baclofen (n526) Mean (SD) Difference (95% CI)

Age (years) 39.5 (9.3) 38.9 (7.8) 0.6 (24.1, 5.4)

Duration of MS diagnosis (years) 7.2 (5.0) 5.3 (2.8) 1.9 (20.37, 4.14)
EDSS 2.8 (1.4) 2.6 (1.3) 0.2 (20.52, 0.94)
Modified Ashworth scale (MAS) right Leg 1.77 (0.29) 1.73 (0.38) 0.04 (20.15, 0.23)
MAS left Leg 1.77 (0.29) 1.73 (0.38) 0.04 (20.15, 0.23)
No. (%) No. (%)
Gender no. (%)
Male 9 (34.6) 6 (23.1) 11.5 (212.9, 36.0)
Female 17 (65.4) 20 (76.9) –
MS subtypes no. (%)
Relapsing-remitting 20 (76.9) 18 (69.2) 7.7 (216.3, 31.7)
Secondary progressive 5 (19.2) 8 (30.8) 211.6 (234.9, 11.8)
Primary progressive 1 (3.8) 0 (0.0) 3.8 (23.6, 11.2)

CI, confidence interval; SD, standard deviation; EDSS, expanded disability status scale; TENS, transcutaneous electrical nerve
stimulation.

Table 2 Comparison of modified Ashworth scale (MAS) in 52 people with multiple sclerosis (MS) before and four weeks
after treatment with self-applied transcutaneous electrical nerve stimulation (TENS) and baclofen

Treatment group

Characteristics TENS (n526) Mean (SD) Baclofen (n526) Mean (SD) Difference (95% CI)

MAS right leg

Baseline 1.77 (0.29) 1.73 (0.38) 0.04 (20.15, 0.23)
After therapy 0.73 (0.70) 1.15 (0.63) 20.42 (20.79, 20.05)*
Difference (95% CI) 1.04 (0.81, 1.28)*** 0.58 (0.37, 0.78)*** –
MAS left leg
Baseline 1.77 (0.29) 1.73 (0.38) 0.04 (20.15, 0.23)
After therapy 0.65 (0.80) 1.15 (0.63) 20.50 (20.85, 20.15)**
Difference (95% CI) 1.12 (0.79, 1.46)*** 0.58 (0.29, 0.87)*** –

*P , 0.05, **P , 0.01, ***P , 0.001. CI, confidence interval; SD, standard deviation.

Neurological Research 2013 VOL . 35 NO . 6 639

 Shaygannejad et al. Baclofen vs TENS in MS-related spasticity
A reduction in MAS was observed in 88.5% (23/26)
of patients during TENS treatment and in 65.4% (17/
26) of patients during baclofen treatment (Fisher’s
exact test 5 0.097).
Baclofen was generally well tolerated and most of
the adverse events reported were mild in severity. The
most common side effects of baclofen were muscle
weakness (n 5 13), dizziness (n 5 7), drowsiness (n 5
6), constipation (n 5 5), urinary frequency (n 5 5),
nausea, and headache (n 5 4). In three participants
this resulted in early discontinuation of baclofen and
the dose of baclofen could not be increased per
protocol due to the side effects. None of participants
had any complaints about the application of TENS.
Discussion
In this trial, both self-applied TENS and baclofen
decreased the spasticity of the lower extremities in
people with MS, but the differences in mean MAS
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were lower in the TENS group. While earlier studies
have demonstrated that both TENS and baclofen are
effective in decreasing spasticity, to the best of our
knowledge, no other studies have directly compared
the relative efficacy of TENS and baclofen.
In this study, participants were supplied with the
TENS units to be used in their homes. It is possible
that this may have positive psychological benefits for
the client, allowing them to feel more in control of
their spasticity.16
Despite some limitations, most but not all earlier
studies have showed that baclofen decreased Ashworth,
or a similar, score more than placebo in MS patients.17–20
One21 reported an improvement in the Cybex score,
but not in the Ashworth score. Transcutaneous
electrical nerve stimulation was reported to decrease
MAS in MS-related spasticity in a few small controlled
study.10,11,22 Armutlu et al.11 reported that TENS
decreased spasticity in the plantar flexor muscles of the
ankle after four weeks of treatment. Another study10
reported that, eight-hour daily application of TENS
led to a significant reduction in muscle spasm. Sluka
et al.22 found that a majority of patients reported
TENS to result in a reduction of pain, spasticity, and
joint stiffness. Transcutaneous electrical nerve stimu-
lation was also reported to decrease spasticity in other
neurological conditions, such as stroke and spinal cord
injury.23–31
The mechanisms of action of TENS and baclofen
are varied. Although TENS is a widely utilized and
accepted mode of intervention for pain manage-
ment, its analgesic mechanisms are not yet fully
understood.32 The most frequently referred hypoth-
esis is the gate control theory, according to which the
nociceptive information from small diameter affer-
ents is inhibited by the stimulation of large diameter
fibers, and thus a response in the dorsal horn is
640 Neurological Research 2013 VOL . 35 NO . 6
prevented.33 Baclofen is a gamma-aminobutyric acid
(GABA) derivative which, unlike the parent com-
pound, crosses the blood–brain barrier, albeit to a
limited extent. Gamma-aminobutyric acid is a major
inhibitor of impulse transmission in the nervous
system, and baclofen is thought to exert an anti-
spastic effect by inhibiting reflex neurological trans-
missions in the spinal cord via its effect on GABA
receptors.34
This trial could draw criticism because of the un-
blind design and the short follow-up. Albeit that the
value of the double-blind, controlled trial is widely
recognized, this design is not always appropriate or
indicated. The inherently different nature of the two
treatment modalities made it impossible to blind the
participants about the treatment group allocation.
Similarly, the treating physicians dealing with clinical
and laboratory adverse events can easily become un-
blinded. However, Schultz and co-workers reported
that, to avoid bias in clinical trials, careful randomi-
zation is more important than a double-blind
design.35 Trials with inadequate randomization yield
an assessment of treatment effects exaggerated by 30–
41% when compared with trials that use adequate
concealment of treatment allocation. By contrast,
trials without double blinding yield an assessment of
treatment effects exaggerated, on average, by only
17% compared with double-blinded trials. In this
study, selection bias was controlled by randomiza-
tion, with concealed treatment allocation, and
observation bias was probably marginal because
clinical results used un-blinded analysis. Another
limitation observed was the relatively short duration
for evaluating the impact of these treatments. It is
possible that a four-week follow-up may be too short
to appreciate the real impact of the therapy.
Assessing the efficacy in the longer term is, therefore,
warranted. While the number of patients studied was
small, the effect was robust.
Based on the partial therapeutic benefits obtained
with TENS, its ease of administration, and lack of
major side effects, these results suggest that this
treatment is useful in the treatment of spasticity in
people with MS. Accordingly, none of our study
patients had any complaints about the application of
this therapy. The present results clearly need to be
replicated and extended across multiple centers and
investigators in a larger scale trial, with a longer
duration of follow-up.
In conclusion, the data further supports the
contention that both TENS and baclofen are useful
interventions in the treatment of spasticity in people
with MS. In this study sample no unusual or
unexpected safety risks were found with TENS
therapy and compliance with the intervention was
good. Transcutaneous electrical nerve stimulation is

an option for treatment of spasticity. Given the side-
effect profile of baclofen, TENS seems to have some
benefits over it as a therapeutic modality for people
with MS. This study suggests that physicians should
carefully weigh the risk and benefits of baclofen and
TENS in people with MS experiencing spasticity.
Authors’ contributions
Janghorbani M. contributed to interpret the results,
and drafted the manuscript. Shaygannejad V. conceived
the study aims and design, contributed to interpret the
results. Vaezi A. and Haghighi S. contributed to data
collection and revised the manuscript. Golabchi K. and
Heshmatipour recruited samples, and contributed to
the discussion and revision of the manuscript. All
authors discussed the results and reviewed and edited
the manuscript.
Conflict of Interest
The authors declare that there is no conflict of
Downloaded by [Tulane University] at 11:41 18 April 2016
interest associated with this manuscript.
Acknowledgements
All authors vouch for the veracity and completeness
of the reported data, and all authors contributed to
various aspects of the trial design, data gathering and
analysis, and preparation of the manuscript. This
work was partially supported by funds from Isfahan
University of Medical Sciences, Iran. This research
was performed as a part of the academic activity of
the university.
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