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Authors:

Gülümser Aydın, MD
Serap Tomruk, MD Spasticity
Işık Keleş, MD
Sibel Özbudak Demir, MD
Sevim Orkun, MD

Affiliations: RESEARCH ARTICLE


From the Department of Physical
Medicine and Rehabilitation,
Kırıkkale University, Faculty of
Medicine, Kırıkkale, Turkey (GA, IK,
SO); and the Physical Medicine and Transcutaneous Electrical Nerve
Rehabilitation Center, Ankara, Turkey
(ST, SÖD). Stimulation Versus Baclofen in
Correspondence: Spasticity:
All correspondence and requests for Clinical and Electrophysiologic Comparison
reprints should be addressed to
Gülümser Aydın, Turan Güneş
Bulvarı 68. sokak No:8/20, 06450 OR-
AN, Ankara, Turkey. ABSTRACT
Aydın G, Tomruk S, Keleş I, Özbudak Demir S, Orkun S: Transcutaneous
Disclosures:
electrical nerve stimulation versus baclofen in spasticity: Clinical and electro-
FIMTM is a trademark of the Uniform physiologic comparison. Am J Phys Med Rehabil 2005;84:584 –592.
Data System for Medical
Rehabilitation, a division of UB Objectives: Clinical and electrophysiologic comparison of the efficacy of
Foundation Activities, Inc.
transcutaneous electrical nerve stimulation (TENS) and oral baclofen in the
0894-9115/05/8408-0584/0 treatment of spasticity.
American Journal of Physical Design: Patients with spinal cord injury and spasticity were included in the study. Ten
Medicine & Rehabilitation
patients were assigned to oral baclofen and 11 to TENS groups. For the comparison of
Copyright © 2005 by Lippincott
Williams & Wilkins
H-reflex variables, 20 healthy individuals were allocated to a control group. TENS was
applied to the tibial nerve for 15 days at a frequency of 100 Hz. Clinical (spasm
DOI: 10.1097/01.phm.0000171173.86312.69 frequency scale, painful spasm scale, lower limb Ashworth score, clonus score, deep
tendon reflex score, plantar stimulation response score) and electrophysiologic evalua-
tions (H-reflex response at the highest amplitude, latency of maximum H-reflex, and ratio
of H-reflex response at the highest amplitude to M response at maximum amplitude) of
the lower limb and functional evaluations (functional disability score and FIMTM) were
carried out in baclofen and TENS groups before and after treatment. Posttreatment
evaluation was made 24 hrs after the 15th session in the TENS group. In addition, clinical
spasticity scores and electrophysiologic variables were measured 15 mins after the first
application and 15 mins after the 15th session.
Results: Significant improvement was detected in lower limb Ashworth score,
spasm frequency scale, deep tendon reflex score, functional disability score, and FIM
in the baclofen (P ⫽ 0.011, P ⫽ 0.014, P ⫽ 0.025, P ⫽ 0.004, and P ⫽ 0.005,
respectively) and TENS (P ⫽ 0.020, P ⫽ 0.014, P ⫽ 0.025, P ⫽ 0.003, and P
⫽ 0.003, respectively) group after treatment. Decrease in H-reflex maximum am-
plitude was significant in the TENS group (P ⫽ 0.026). Most marked improvement
was observed in the third evaluation, 15 mins after the 15th session, particularly in
lower limb Ashworth score (P ⫽ 0.006) and H-reflex maximum amplitude (P ⫽
0.006) in the TENS group. The percentage change in clinical, electrophysiologic,
and functional variables caused by baclofen was not different from that caused by
repeated applications of TENS in the short- and long-term evaluations (P ⬎ 0.05).
Conclusion: TENS may be recommended as a supplement to medical
treatment in the management of spasticity.
Key Words: Spinal Cord Injury, Spasticity, Baclofen, Transcutaneous Electrical Nerve
Stimulation

584 Am. J. Phys. Med. Rehabil. ● Vol. 84, No. 8


T he definition of spasticity according to the lit-
erature is as follows: (1) increased muscle tone, (2)
it may be used, per se, as an alternative to medical
treatment or as an adjunct to it.
This study had two aims, namely, (1) deter-
increased tendon reflexes, (3) increased exterocep- mining the short- and long-term efficacy of TENS
tive reflexes, and (4) pathologic radiation of re- after repeated applications in patients with SCI on
flexes. Its prevalence has been reported to be 12– spasticity by means of clinical, electrophysiologic,
37% in patients with spinal cord injury (SCI).1 and functional variables, and (2) comparing the
When spasticity exceeds a certain degree, it be- short- and long-term efficacy of TENS with ba-
comes a difficult problem that should be dealt with clofen treatment.
by a neurological rehabilitation team. In spasticity
treatment, the factors increasing spasticity should METHODS
be eliminated first. Physical methods and medical
Subjects
treatment are the second step. One of the basic
drugs used in the treatment of spasticity is ba- A total of 21 adult patients with traumatic SCI
clofen, which is bound to ␥-aminobutyric acid B and problematic spasticity, defined as being painful
receptors in the brain and neurons and acts on the or restricting activities of daily life, or both,1 who
terminals of primary efferents at the spinal level. In were admitted to the Ankara Physical Medicine and
the therapeutic range, the presynaptic effects of Rehabilitation Center for rehabilitation between
baclofen suppress release of excitatory transmitters January 2000 and February 2001 were included in
for both monosynaptic and polysynaptic pathways. the study. Those with complications that can cause
Therefore, baclofen is frequently preferred, espe- spasticity to increase (heterotopic ossification, uri-
cially in the medical treatment of spasticity of nary infection, pressure ulcer), those with systemic
spinal origin.2– 4 diseases that can cause peripheral neuropathy, or
Physical treatment modalities that have been those diagnosed with lumbosacral radiculopathy,
used in spastic hypertonia are, particularly, super- impairment in liver and kidney functions, and obe-
ficial heat and cold, diathermies, electrical stimu- sity were excluded from the study. Patients who
lation, implanted spinal stimulation, and massage. had undergone any treatment for spasticity previ-
The duration of the effects of most physical thera- ously were not included in the study. The informa-
pies is relatively short, which often may limit their tion about the patients and their clinical charac-
application to immediate prestretch or pre-exercise teristics according to American Spinal Injury
periods.5 In the literature, the investigations on the Association classification were recorded.19 Labora-
effect of electric stimulation on spasticity report tory investigations, including liver and kidney
variable results. Some authors have reported that functions tests, complete blood count, and creatine
electrical stimulation decreases spasticity.6 –16 clearance, were repeated every 2 wks throughout
However, stimulation patterns, application meth- baclofen administration. To interpret the effect of
ods, measurement techniques, and the timing of treatments on electrophysiologic variables better,
the evaluation are quite variable. Among these, in 20 volunteers matched for age were chosen as the
studies investigating the short-term effects (⬍1 hr) control group for electrophysiologic evaluations. A
after a single session in which high-frequency elec- control group comprised volunteering, healthy
trical stimulation is preferred, decrease in spastic- hospital staff and people accompanying patients.
ity has been reported in clinical measure- All procedures were approved by the Human Stud-
ments.7,10 –15 In some studies, it has been ies Research Committee of the Ankara Rehabilita-
established that the improvement in spasticity was tion Center, and written informed consent was
maintained through repeated applications of high- obtained from each subject before inclusion in the
frequency electrical stimulation.8,9,11,12 At present, study. The patients were randomized into treat-
transcutaneous electrical nerve stimulation ment groups considering the duration required for
(TENS) is not used commonly in the treatment of evaluation. Accordingly, the first ten patients were
spasticity. To our knowledge, there is no study included in the baclofen treatment group and the
comparing the efficacy of TENS in spasticity with second 11 patients in the TENS treatment group.
drug treatment. However, TENS is a noninvasive All patients were inpatients and concomitantly re-
and readily applicable method that has few side ceived exercise therapy, including range of motion,
effects and no drug interactions, no potential tox- every morning.
icity, can be applied by the patient, and is less
costly in the long term compared with drug treat- Interventions
ment.17 Baclofen and similar drugs have limited The major goals of the treatments were to
efficacy in muscle relaxation and have side effects improve the signs of problematic spasticity (i.e.,
such as muscle weakness.2,18 Thus, if adequate increased muscle tone, clonus, and the flexor
improvement in spasticity is obtained with TENS, spasm) in patients with SCI to a reasonable level.

August 2005 Baclofen and TENS in Spasticity 585


Baclofen Administration calculated as follows: the muscle tone of the exten-
In the baclofen treatment group, the dose was sor and flexor muscles at the hip, knee, and ankle
increased by 5 mg every 3 or 5 days, considering joints of the nondominant side were examined us-
the tolerance of the patient, until adequate clinical ing the Ashworth score (0, no increase in tone; 4,
response was obtained or a maximum 80 mg/day limb rigid), and a total Ashworth score of those six
was reached. The individual daily doses varied ac- muscle groups, described as the lower limb Ash-
cording to the patient’s tolerance and were divided worth score, with a maximum score of 24, was
into three oral doses. After 8 wks, posttreatment obtained.20,21 In the ankle, clonus score was eval-
evaluation was made. All the patients in the ba- uated between 0 and 3 (0, absent; 3, spontaneous/
clofen treatment group were asked for side effects, provoked by light touch); in the Achilles, deep
including sedation, drowsiness, dizziness, nausea, tendon reflex score was evaluated between 0 and 4
dry mouth, fatigue, and muscle weakness. Neuro- (0, no reflex; 4, very brisk, hyperactive, associated
logical examination was performed on all the pa- with clonus); and in the sole, plantar stimulation
tients weekly. response score was evaluated between 0 and 3 (0,
no visible activity/flexor response; 4, movement
TENS Application elicited by light touch).20 For the evaluation of
disability related to functional status of the pa-
In the TENS treatment group, the TENS Sys-
tients, the functional disability score, which eval-
tems 2000 TENS device was used. Stimulations
uates pain, spasms, sitting position, body transfer,
were provided with carbon electrodes and conduct-
washing, and putting on clothes, which had an
ing gel on bilateral tibial nerves in a manner that
overall score of 20 and was developed for lower
would involve the gastrocnemius muscle. Biphasic
limbs, was employed as a global functional evalu-
square waves at the intensity of 50 mA, which
ation score.22 In addition, mobility, self-care, com-
would not cause contractions, were used at a fre-
munication, and social and cognitive functions of
quency of 100 Hz and duration of 100 msecs. Treat-
patients were evaluated by FIMTM, the scores of
ment was organized as 15 sessions lasting for 15
which ranged from 18 to 126.23
mins and applied once a day.
Electrophysiologic Assessment of Spasticity
Outcome Assessments
Electrophysiologic investigations included H-
Clinical evaluations of spasticity were con- reflex variables of the nondominant lower limb,
ducted by a physiatrist, and the electrophysiologic and the Medelec-MS92 electromyographic device
investigations were carried out by another physia- (Medelec, London, UK) was used.
trist. They were not blinded to the interventions, Stimulation and recording was carried out
but they were blinded to the evaluation results of with surface electrodes, at the range of 20 Hz to 10
each others. Outcome assessments of all patients KHz. Silver electrodes, 1 cm in diameter, were used
were performed almost 8 hrs after the exercise for recording. Measurements were made at room
therapy. temperatures of 20 –22 degrees centigrade and with
skin temperature around 31 degrees centigrade,
Clinical Assessment of Spasticity with the patient in the prone position and with
Clinical evaluation of spasticity was carried out the feet suspended over the edge of the table. For
according by both self-reporting of the patient the evaluation of H reflex and M responses in the
(self-report scores) and the examination of physia- gastrocnemius muscle, the stimulating electrode
trist (clinical examination scores). In the evalua- was placed just medial to the midpoint of the knee
tion of self-report, the spasm frequency scale (SFS) crease in the popliteal fossa (the active stimulating
modified from Penn and painful spasm scale were electrode is proximally located), and the recording
used. With SFS, the emergence pattern of spasm in electrode was placed halfway between the popliteal
the day and its frequency were inquired and eval- crease and the proximal medial malleolus over the
uated on a scale ranging from 0 to 4 (0, no spasms; medial gastrocnemius. The ground electrode was
4, spontaneous spasms occurring more than ten connected between the active and passive elec-
times per hour). To what degree spasms cause pain trodes. For stimulation, rectangular flow at the
and disturbance was determined on a scale ranging frequency of 0.5 Hz and duration of 0.5–1.0 msecs
from 0 to 2 (0, causes no discomfort or pain; 2, was used. Sweep speed of 10 msecs and sensitivity
causes severe discomfort or severe pain) by painful of 500 ␮V was chosen. First, M response at maxi-
spasm scale.20 mum amplitude (Mmax) and then H-reflex response
Clinical assessments of spasticity included ex- at the highest amplitude (Hmax) was recorded by
amination of lower limb muscle tone, deep tendon changing the intensity of stimulation without mov-
reflex of Achilles, ankle clonus, and plantar stimu- ing the stimulator.24 The latencies were measured
lation. The lower limb overall muscle tone was from the stimulus onset to the beginning of the

586 Aydın et al. Am. J. Phys. Med. Rehabil. ● Vol. 84, No. 8
initial deflection of compound motor action poten- sidered significant. In investigation of clinical ex-
tial, and amplitude was measured from peak to amination scores and of H-reflex variables repeated
peak. Afterward, Hmax/Mmax (H/M) amplitude ratios multiple measurements in the TENS group, Fried-
were calculated. man’s test and, afterward, Wilcoxon’s signed-ranks
Clinical, electrophysiologic, and functional test were used. Because three pairs of comparisons
evaluations were made before and after treatment were studied, with Bonferroni adjustment, the er-
in the baclofen group. In the TENS group, four ror rate allowed in each significance testing was
evaluations were made, namely: a first evaluation 0.016 (i.e., 0.05 divided by 3).
before treatment (IE), a second evaluation 15 mins
after the first session to determine the short-term RESULTS
effect after a single session (IIE), a third evaluation Descriptive Data
15 mins after the 15th session to determine the The descriptive characteristics of patients in
short-term effect after repeated application (IIIE), treatment groups are shown in Table 1. The ba-
and a fourth evaluation 24 hrs after the 15th ses- clofen group consisted of ten female patients with
sion to determine the long-term effect after re- traumatic SCI. Of those, three had tetraplegia with
peated application (IVE). IVE was defined as the cervical injury and seven had paraplegia with tho-
posttreatment evaluation in the TENS group. Eval- racic injury. The mean age of the baclofen group
uations of functional status and evaluations of self- was 32.70 ⫾ 16.30 yrs, and the time postinjury was
report were made only in IE and IVE. 11.47 ⫾ 11.70 mos, with a range of 4 – 44 mos. The
TENS group consisted of 11 patients (five women,
Statistical Analysis six men) with traumatic SCI. Of those, two had
In the statistical analysis of the data, the SPSS tetraplegia with the cervical injury and nine had
for Windows 10.0 package program was used paraplegia with thoracic injury. The mean age of
(SPSS, Chicago, IL). Descriptive statistical vari- the TENS group was 29.27 ⫾ 7.33 yrs, and the time
ables were calculated to document the character- postinjury was 11.48 ⫾ 13.92 mos, with a range of
istics of patients and controls. Comparison of age 2– 49 mos. There was no statistically significant
and time after injury between treatment groups difference between the two treatment groups in
was performed by using the Mann-Whitney U test. terms of mean age and time postinjury (P ⬎ 0.05).
Comparison of age between treatment and control In the baclofen group, it was required to increase
groups was performed by using the Kruskal-Wallis the dosage to maximum in all of the patients. Side
test. Wilcoxon’s signed-ranks test was used in the effects due to baclofen included dryness of mouth
comparison of before- and after-treatment values in three patients and fatigue in two patients. In
in the baclofen and TENS groups; in the compari- weekly routine neurological examination, weak-
son between both treatment groups and the con- ness of muscles was not seen.
trol group and in the comparison of percentage The control group consisted of 20 subjects (8
change caused by both treatments, the Mann-Whit- women, 12 men), with a mean age of 33.90 ⫾ 11.44
ney U test was used. A P value of ⬍0.05 was con- yrs. There was no statistically significant difference

TABLE 1 Characteristics of patients with spinal cord injury


Baclofen Group TENS Group

n ⴝ 10 % n ⴝ 11 %

Sex Female 10 100 5 45.5


Male ⫺ ⫺ 6 54.5
Cause of injury Traffic Accident 4 40 6 54.5
Gunshot 1 10 1 9.1
Fall 1 10 2 18.2
Acts of violence 2 20 1 9.1
Sports 2 20 1 9.1
Level of injury Cervical 3 30 2 18.2
Thoracic 7 70 9 81.8
ASIA score A 5 50 5 45.4
B 1 10 2 18.2
C 3 30 4 36.3
D 1 10 –- –-
TENS, transcutaneous electrical nerve stimulation; ASIA, American Spinal Injury Association.

August 2005 Baclofen and TENS in Spasticity 587


between the mean age of the control group and change was observed in IIIE, especially in Hmax
those of the treatment groups (P ⬎ 0.05). amplitude (P ⬍ 0.01), and the least change was
observed in IIE. In repeated measurements of the
Clinical Indicators of Spasticity TENS treatment group, comparison of the electro-
Values of clinical findings of spasticity and physiologic variables are shown in Table 6.
functional status scales in both treatment groups The percentage change in clinical, electro-
before and after treatment are illustrated in Table physiologic, and functional variables caused by ba-
2. In both treatment groups, improvement was clofen was not found to be different from that
observed in SFS, lower limb Ashworth score, deep caused by repeated applications of TENS in short-
tendon reflex score, and functional status scales and long-term evaluations (P ⬎ 0.05) (Table 7).
after treatment (P ⬍ 0.05). In repeated measure-
ments of the TENS treatment group, comparison DISCUSSION
of the clinical examination scores of spasticity are There are many studies in the literature on
shown in Table 3. When the short-term effect of baclofen treatment employed commonly in the
TENS after a single session (IIE), short-term effect treatment of spasticity. Duncan et al.18 established
after 15 sessions (IIIE), and long-term effect (IVE) that in patients with chronic SCI, baclofen treat-
on clinical examination scores of spasticity were ment decreased the frequency of involuntary flexor
compared, the most pronounced change was ob- or extensor spasms and improved the increased
served in IIIE, especially in lower limb Ashworth resistance of leg to passive movements, but it did
score, and the least change was observed in IIE. not influence gait, stretch reflex, or clonus. Mi-
lanov4 reported that in poststroke hemiplegic pa-
Electrophysiologic Indicators of tients, baclofen treatment reduced increased mus-
Spasticity cle tonus, depressed Babinski sign, and had no
Baclofen treatment achieved a decrease in effect on muscle strength, ankle clonus, and deep
Hmax amplitude and H/M amplitude ratios that was tendon hyperreflexes. Nielsen and Sinkjaer21 re-
not statistically significant. The comparison of the ported that in multiple sclerosis patients with spas-
electrophysiologic values obtained before and after ticity, oral baclofen administration decreased ankle
baclofen treatment with each other and with the tension by 20%. In the present study, in the group
control group is given in Table 4. TENS reduced administered baclofen, when spasticity was evalu-
Hmax amplitude significantly. The comparison of ated clinically, significant improvements in SFS,
the electrophysiologic values obtained before and lower limb Ashworth score, and deep tendon reflex
after TENS treatment with each other and with the score were observed. In addition, there were sig-
control group is given in Table 5. nificant improvements in FIM and functional dis-
When the effect of TENS on electrophysiologic ability scores, which evaluated functional status.
variables in the IIE, IIIE, and IVE evaluations were Our findings have demonstrated that baclofen de-
compared with each other, the most prominent creased spasticity in patients with SCI and were

TABLE 2 Comparison of self-report scores, clinical examination scores, and functional status scales
of spasticity pretreatment and posttreatment in baclofen and transcutaneous electrical
nerve stimulation (TENS) groups
Baclofen Treatment TENS Treatment

Pre Post Pre Post


(n ⴝ 10) (n ⴝ 10) P Value (n ⴝ 11) (n ⴝ 11) P Value

SRS SFS 3.3 ⫾ 0.9 2.3 ⫾ 0.3 0.014 3.1 ⫾ 0.7 2.6 ⫾ 0.6 0.014
PSS 1.2 ⫾ 0.9 1.1 ⫾ 0.9 0.317 1 ⫾ 0.6 0.7 ⫾ 0.6 0.180
CES LLAS 19.2 ⫾ 3.7 14.4 ⫾ 6.4 0.011 20.1 ⫾ 4 16.3 ⫾ 2.8 0.020
CS 2.3 ⫾ 1 1.9 ⫾ 0.9 0.102 2.6 ⫾ 1 2.1 ⫾ 0.8 0.059
DTRS 3.8 ⫾ 0.4 3.3 ⫾ 0.6 0.025 3.6 ⫾ 0.5 3.1 ⫾ 0.4 0.025
PSRS 2.2 ⫾ 0.9 1.9 ⫾ 0.7 0.083 2.6 ⫾ 0.8 2.2 ⫾ 0.4 0.102
FSS FDS 11.4 ⫾ 2.2 8.5 ⫾ 2.4 0.004 12 ⫾ 2.6 8.6 ⫾ 1.6 0.003
FIMTM 67 ⫾ 11.6 75.7 ⫾ 12.6 0.005 68.5 ⫾ 7.6 76.2 ⫾ 9.7 0.003
SRS, self-report scores; SFS, spasm frequency scale; PSS, painful spasm scale; CES, clinical examination scores; LLAS, lower
limb Asworth score; CS, clonus score; DTRS, deep tendon reflex score; PSRS, plantar stimulation response score; FSS, functional
status scores; FDS, functional disability score.
Data are expressed as mean ⫾ SD; level of significance set at P ⬍ 0.05, Wilcoxon’s signed-ranks test, with bold type
indicating significance.

588 Aydın et al. Am. J. Phys. Med. Rehabil. ● Vol. 84, No. 8
TABLE 3 Comparison of the clinical examination scores of spasticity in repeated measurements of
the transcutaneous electrical nerve stimulation treatment group
IE IIE IIIE IVE P Value P Value P Value
(n ⴝ 11) (n ⴝ 11) (n ⴝ 11) (n ⴝ 11) I–II I–III I–IV

CES LLAS 20.1 ⫾ 4 17.4 ⫾ 1.8 13.6 ⫾ 3.8 16.3 ⫾ 2.8 0.059 0.006 0.020
CS 2.6 ⫾ 1 2.2 ⫾ 0.9 2.3 ⫾ 0.6 2.1 ⫾ 0.8 0.046 0.257 0.059
DTRS 3.6 ⫾ 0.5 3.3 ⫾ 0.5 3 ⫾ 0.7 3.1 ⫾ 0.4 0.083 0.020 0.025
PSRS 2.6 ⫾ 0.8 2.5 ⫾ 0.5 2 ⫾ 0.8 2.2 ⫾ 0.4 0.564 0.034 0.102
IE, evaluation before treatment; IIE, evaluation 15 mins after first application; IIIE, evaluation 15 mins after 15th session;
IVE, evaluation 24 hrs after 15th session; CES, clinical examination scores; LLAS, lower limb Asworth score; CS, clonus score;
DTRS, deep tendon reflex score; PSRS, plantar stimulation response score.
Data are expressed as mean ⫾ SD; bold type indicates statistical significance.
Level of significance set at P ⬍ 0.01, Wilcoxon signed-ranks test with Bonferroni adjustment.

TABLE 4 Comparison of the electrophysiologic values obtained before and after baclofen treatment
with each other and with the control group
Before After
Control Baclofen Baclofen P Valuea P Valuea P Valueb
(n ⴝ 20) (n ⴝ 10) (n ⴝ 10) C-Pre C-Post Pre-Post

Hmaxamp, mV 3.7 ⫾ 2.7 5.5 ⫾ 3.6 4.3 ⫾ 2.9 0.048 0.322 0.139
Hmaxlat, msecs 29.6 ⫾ 1.9 30.7 ⫾ 2.4 31.1 ⫾ 2.6 0.217 0.117 0.590
H/M 0.1 ⫾ 0.2 0.5 ⫾ 0.2 0.4 ⫾ 0.3 0.001 0.009 0.241
C-Pre, control–before treatment; C-Post, control–after treatment; Pre-Post, before treatment–after treatment; Hmaxamp,
H-reflex response at the highest amplitude; Hmaxlat, latency of maximum H-reflex; H/M, ratio of H-reflex response at the highest
amplitude to M response at maximum amplitude.
Data are expressed as mean ⫾ SD; level of significance set at P ⬍ 0.05, with bold type indicating statistical significance.
a
Mann-Whitney U test.
b
Wilcoxon’s signed-ranks test.

TABLE 5 Comparison of the electrophysiologic values obtained before and after transcutaneous
electrical nerve stimulation (TENS) treatment with each other and with the control group
Before
Control TENS After TENS P Valuea P Valuea P Valueb
(n ⴝ 20) (n ⴝ 11) (n ⴝ 11) C-Pre C-Post Pre-Post

Hmaxamp, mV 3.7 ⫾ 2.7 3.1 ⫾ 2.7 2.3 ⫾ 2.3 0.322 0.032 0.026
Hmaxlat, msecs 29.6 ⫾ 1.9 30.4 ⫾ 2.5 30.2 ⫾ 3.2 0.331 0.142 0.878
H/M 0.1 ⫾ 0.2 0.4 ⫾ 0.7 0.4 ⫾ 1 0.186 0.773 0.328
C-Pre, control–before treatment; C-Post, control–after treatment; Pre-Post, before treatment–after treatment; Hmaxamp,
H-reflex response at the highest amplitude; Hmaxlat, latency of maximum H-reflex; H/M, ratio of H-reflex response at the highest
amplitude to M response at maximum amplitude.
Data are expressed as mean ⫾ SD; level of significance set at P ⬍ 0.05, with bold type indicating statistical significance.
a
Mann-Whitney U test.
b
Wilcoxon’s signed-ranks test.

found to be congruent with other studies4,18,21 TENS should be known. Studies in the literature
reporting that baclofen reduced clinical spasticity, on application of TENS mostly evaluate the short-
particularly flexor spasms. Although baclofen has a term activity after a single session. Bajd et al.7
favorable effect on spasticity, it has some side ef- established that there was a decrease in spasticity
fects.3,18 In the present study, no major side effect after a 20-min, single session of TENS (100 Hz,
requiring the study to be discontinued was ob- 0.3-msec pulse duration, 50 mA) administered on
served. L3-L4 dermatomes. Hui-Chan et al.10 determined a
To determine the role of TENS in the treat- reduction in clinical spasticity score in the der-
ment of spasticity, short- and long-term effects of matome measurements they made at 20, 40, and 60

August 2005 Baclofen and TENS in Spasticity 589


TABLE 6 Comparison of electrophysiologic variables in repeated measurements of the
transcutaneous electrical nerve stimulation treatment group
IE IIE IIIE IVE P Value P Value P Value
(n ⴝ 11) (n ⴝ 11) (n ⴝ 11) (n ⴝ 11) I–II I–III I–IV

Hmaxamp, mV 3.1 ⫾ 2.7 2.4 ⫾ 2.1 2.1 ⫾ 2.5 2.3 ⫾ 2.3 0.021 0.006 0.026
Hmaxlat, msecs 30.4 ⫾ 2.5 31.2 ⫾ 2.8 30.5 ⫾ 3.4 30.2 ⫾ 3.2 0.086 0.878 0.876
H/M 0.4 ⫾ 0.7 0.3 ⫾ 0.5 0.3 ⫾ 0.8 0.4 ⫾ 1 0.021 0.155 0.328
IE, evaluation before treatment; IIE, evaluation 15 mins after first application; IIIE, evaluation 15 mins after 15th session;
IVE, evaluation 24 hrs after 15th session; Hmaxamp, H-reflex response at the highest amplitude; Hmaxlat, latency of maximum
H-reflex; H/M, ratio of H-reflex response at the highest amplitude to M response at maximum amplitude.
Data are expressed as mean ⫾ SD; level of significance set at P ⬍ 0.01 (with bold type indicating statistical significance),
Wilcoxon’s signed-ranks test with Bonferroni adjustment.

TABLE 7 Comparison of percentage changes in outcome measurements of spasticity obtained by


baclofen and transcutaneous electrical nerve stimulation (TENS) treatments
Baclofen TENS
(n ⴝ 10) (n ⴝ 11)

Pre-Post IE–IIIE IE–IVE P Valuea P Valueb

SFS ⫺28 ⫾ 30 NE ⫺16 ⫾ 16 –- 0.459


PSS ⫺10 ⫾ 32 NE ⫺18 ⫾ 40 –- 0.602
FDS ⫺26 ⫾ 12 NE ⫺26 ⫾ 13 –- 0.915
FIMTM 13 ⫾ 6 NE 11 ⫾ 7 –- 0.460
LLAS ⫺28 ⫾ 22 ⫺32 ⫾ 19 ⫺17 ⫾ 17 0.610 0.163
CS ⫺14 ⫾ 50 0 ⫾ 38 ⫺14 ⫾ 21 0.340 0.731
DTRS ⫺13 ⫾ 14 ⫺17 ⫾ 18 ⫺11 ⫾ 13 0.568 0.690
PSRS ⫺10 ⫾ 16 ⫺19 ⫾ 24 ⫺5 ⫾ 38 0.416 0.780
Hmaxamp, mV ⫺15 ⫾ 46 ⫺30 ⫾ 33 26 ⫾ 180 0.384 0.888
Hmaxlat, msecs 2⫾6 0⫾9 0⫾8 0.713 0.464
H/M ⫺11 ⫾ 48 ⫺29 ⫾ 40 16 ⫾ 136 0.481 0.944
IE, evaluation before treatment; IIIE, evaluation 15 mins after 15th session; IVE, evaluation 24 hrs after 15th session; ,
percentage change; SFS, spasm frequency scale; NE, not evaluated; PSS, painful spasm scale; FDS, functional disability score;
LLAS, lower limb Ashworth score; CS, clonus score; DTRS, deep tendon reflex score; PSRS, plantar stimulation response score;
Hmaxamp, H-reflex response at the highest amplitude; Hmaxlat, latency of maximum H-reflex; H/M, ratio of H-reflex response at
the highest amplitude to M response at maximum amplitude.
Data are expressed as mean ⫾ SD; level of significance set at P ⬍ 0.05, Mann-Whitney U test.
a
Comparison of percentage change in clinical examination and electrophysiologic outcome measurements of baclofen
before and after treatment and TENS IE–IIIE.
b
Comparison of percentage change in all outcome measurements of baclofen before and after treatment and TENS
IE–IVE.

mins after a single session of TENS (99 Hz, 0.125- cation of TENS at 100 Hz for 20 mins on the sural
msec pulse duration; 2⫻ sensory threshold) lasting nerve in hemiplegic individuals reduced clinical
for 45 mins and administered on the median and spasticity in the short term and inhibited stretch-
common peroneal nerves in patients with spastic reflex excitability. Goulet et al.14 reported that
hemiparesis. Han et al.12 administered low- and when TENS (99 Hz, 250-msec pulse duration, 15
high-frequency TENS for 30 mins once a day to the mA) was applied to the common peroneal nerve in
acupuncture points on the feet and hands of pa- patients with SCI for 30 mins, the evaluations at 10
tients with muscle spasticity of spinal origin and and 30 mins later demonstrated reduction in Achil-
reported a reduction in spasticity in ⬍30 mins in les tendon reflex and modified Ashworth scores.
the group administered high-frequency (100 Hz, Wang et al.15 established that sensory stimulation
0.3-msec pulse duration, 0 –50 mA). Yu11 has pro- to T12-L1 spinal muscles for 45 mins at 250 Hz
posed that high-frequency electrical stimulation to lowered spasticity in hemiplegic patients. In the
the acupuncture points in the treatment of spinal present study, at IIE, which evaluated short-term
spasticity immediately exerted an antispastic effect, effect 15 mins after a single session, a decrease was
which could be maintained for 3 mos with daily observed in all measurements in clinical examina-
administration. Potisk et al.13 reported that appli- tion scores compared with pretreatment values.

590 Aydın et al. Am. J. Phys. Med. Rehabil. ● Vol. 84, No. 8
However, the difference was not statistically signif- In a study evaluating the efficacy of baclofen
icant. Our findings were not consistent with those electrophysiologically, it has been reported that ba-
of studies7,10,12–15 reporting that high-frequency, clofen reduced the H/M ratio.27 In the present study
single-session TENS improves clinical variables in as well, in the baclofen treatment group, Hmax am-
the short term. It is reported that the longer the plitude values and H/M ratio was significantly higher
duration of TENS, the longer its effects lasts.10 The compared with the control group; after treatment, no
fact that the difference obtained in our study was difference was observed with the control group in
not significant, unlike other studies, may be attrib- terms of Hmax amplitude values. Although there was
uted to the short duration of TENS in our study (15 a decrease in H/M amplitude ratios compared with
mins vs. 30 – 45 mins). In addition, a low number of pretreatment values, it was not significant.
cases, differences of stimulation variables, and eval- The results obtained in studies investigating
uation methods may be other factors influencing the efficacy of TENS electrophysiology are contro-
treatment outcome. versial. In patient groups with spasticity, after a
In the literature, there are studies reporting single-session, high-frequency TENS application,
that the decrease brought about by electric stimu- in the short term, Goulet et al.14 reported that
lation is not maintained in the long term (up to 24 Hmax amplitude and H/M amplitude ratios re-
hrs).6,7 However, Han et al.,12 in their study inves- mained unchanged, Hui-Chan et al.10 reported that
tigating long-term effect after repeated application, Hmax latency was sustained and H/M amplitude
reported that the decrease in spasticity they ob- ratios remained the same, and Joodaki et al.28 re-
tained in the short term continued for 18 hrs after ported that Hmax amplitude, H/M amplitude ratio,
the last session–-they applied TENS for 30 mins, and F-wave/M-response amplitude ratio decreased.
twice a day, for 3 mos. In the present study, no Levin and Hui-Chan9 reported that they did not
significant change was observed in any clinical find any change in H/M amplitude ratios after re-
examination score after a single-session TENS ap- peated TENS application. In the present study,
plication. However, after repeated applications of there was significant reduction in Hmax amplitude
TENS, significant decrease was observed in lower in measurements after treatment compared with
limb Ashworth and deep tendon reflex scores in pretreatment values. When repeated measurements
short-term measurements. These results suggest were compared with each other, the most significant
that repeated applications in TENS treatment in- decrease was in the short-term evaluation (IIIE) after
crease short-term efficacy. There were significant repeated measurements. H/M ratio decreased in all
improvements in SFS, functional disability score, measurements, even if not significantly.
and FIM at IVE; these variables were evaluated only In both treatment methods, the improvement
in IE and IVE. Although improvement in all clinical in electrophysiologic measurements was less
examination scores was observed in repeated mea- marked than that obtained clinically. Although it is
sures in IVE when compared with IIE, there was no thought that a single mechanism may be adequate
significant difference in any score after Bonferroni for the development of spasticity, it is also regarded
adjustment (P ⬎ 0.016). Increasing the duration and that two or more of these mechanisms are observed
frequency of daily sessions may cause a significant in spasticity.25,26 H-reflex variables represent lim-
increase in long-term efficacy, which is a postulate ited neural physiologic mechanisms of spasticity.
that should be investigated in another study. Clinical scales may be considered a general reflec-
In both treatment groups, the improvement in tion of these mechanisms. Hence, a complete cor-
FIM and functional disability scores may be con- respondence between clinical expression of spastic-
sidered as a sign of the favorable developments in ity and individual electrophysiologic variables
the clinical symptoms of spasticity. However, the cannot be expected. Actually, most of the studies
improvements observed in both treatment groups evaluating clinical expression of spasticity could
could not be attributed to only the particular effect not find a correlation between clinical expression
of those treatments because all patients also re- and electrophysiologic variables.9,14,26,29 So, it
ceived exercise therapy concomitantly. This condi- should not be considered surprising that alter-
tion may be considered as a limitation of this study. ations in electrophysiologic variables that evaluate
The influence of treatment method on spinal only alpha motor neurone activity were not as
neurone and segmental reflexes is mostly evaluated substantial as those in clinical variables.
by electrophysiologic methods.3,25 It is known that The effect of TENS was observed most mark-
many mechanisms play a role in the development edly in the short-term evaluation after repeated
of spasticity. Among these, primary and secondary applications. Although this effect lessened 24 hrs
increases in alpha motor neurone activity are the after the last application, it was still maintained.
most implicated, and it is considered that H-reflex The effect obtained in the short and long term after
and F-wave variables represent these mechanisms repeated applications was not different from that
in electrophysiology.25,26 obtained with baclofen.

August 2005 Baclofen and TENS in Spasticity 591


There were some other limitations in this nerve stimulation for treatment of spinal spasticity. Chin
study such that only electrophysiologic evaluation Med J 1994;107:6–11
was used as the objective outcome assessment 13. Potisk KP, Gregoric M, Vodovnik L: Effects of transcutaneous
electrical nerve stimulation (TENS) on spasticity in patients
method. In addition, the validity of clinical tests with hemiplegia. Scand J Rehabil Med 1995;27:169–74
used in this study may be a concern of limitation. 14. Goulet C, Arsenault AB, Bourbonnais D, et al: Effects of
Although the Ashworth scale is used widely and is transcutaneous electrical nerve stimulation on H-reflex and
validated, other clinical tests may be poor for va- spinal spasticity. Scand J Rehabil Med 1996;28:169–76
lidity, except for SFS.20 Another limitation was the 15. Wang RY, Chan RC, Tsai MW: Effects of thoraco-lumbar
electric sensory stimulation on knee extensor spasticity of
lack of blinding of physiatrists to the interventions persons who survived cerebrovascular accident (CVA).
due to the frequent repeated measurements in the J Rehabil Res Dev 2000;37:73–9
TENS treatment group. 16. Hardy SG, Spalding TB, Liu H, et al: The effect of transcu-
In conclusion, TENS may be recommended as taneous electrical stimulation on spinal motor neuron ex-
citability in people without known neuromuscular diseases:
adjuvant treatment before stretch and range of The roles of stimulus intensity and location. Phys Ther
motion exercises and in periods before sleep when 2002;82:354–63
an increase in hyper reflex activity is observed. In 17. Johnson M: Transcutaneous electrical nerve stimulation
addition, due to its effect in the long term after (TENS), in Kitchen S (ed): Electrotherapy: Evidence-Based
Practice. Edinburgh, Churchill Livingstone, 2002, pp 259–86
repeated applications, it may be used as a supple-
18. Duncan GW, Shahani BT, Young RR: An evaluation of
ment to medical treatment in spasticity. baclofen treatment for certain symptoms in patients with
In current literature, it is reported that the cho- spinal cord lesions: A double-blind, cross-over study. Neu-
sen frequency and intensity in electrical stimulation rology 1976;26:441–6
exerts different effects in different regions of the ner- 19. Maynard FM, Bracken MB, Creasey G, et al: International
standards for neurological and functional classification of
vous system through different receptors.16,30,31 spinal cord injury. Spinal Cord 1997;35:266–74
Therefore , it is our proposition that further studies 20. Priebe MM, Sherwood AM, Thornby JI, et al: Clinical assess-
using different stimulation variables or daily stimu- ment of spasticity in spinal cord injury: A multidimensional
lation periods, or both, are warranted to determine if problem. Arch Phys Med Rehabil 1996;77:713–6
the short-term effect of repeated TENS application 21. Nielsen JF, Sinkjaer T: Peripheral and central effect of
baclofen on ankle joint stiffness in multiple sclerosis. Mus-
can be maintained in the long term. cle Nerve 2000;23:98–105
REFERENCES 22. Sindou M, Millet MF: Quantification of spasticity and limb
function (based on clinical examination, and directed to
1. Sköld C, Levi R, Seiger A: Spasticity after traumatic spinal adult patients), in Sindou M, Abbott R, Keravel Y (eds):
cord injury: Nature, severity, and location. Arch Phys Med Neurosurgery for Spasticity. New York, Springer-Verlag-
Rehabil 1999;80:1548–57 Wien, 1991, pp 47–50
2. Gracies JM, Nance P, Elovic E, et al: Traditional pharma- 23. Granger CV, Kelly-Hayes M, Johnston M, et al: Quality and
cological treatments for spasticity: Part II. General and outcome measures for medical rehabilitation, in Braddom
regional treatments. Muscle Nerve 1997;6:92–120 RL (ed): Physical Medicine and Rehabilitation. Philadel-
3. Boisson D, Eyssette M: Medical treatment of spasticity, in phia, WB Saunders, 2000, pp 151–64
Sindou M, Abbott R, Keravel Y (eds): Neurosurgery for 24. Oh JS: Nerve conduction techniques, in Retford DC (ed):
Spasticity. New York, Springer-Verlag-Wien, 1991, pp Clinical Electromyography: Nerve Conduction Studies.
59–62 Baltimore, Williams and Wilkins, 1993, pp 39–55
4. Milanov IG: Mechanisms of baclofen action on spasticity.
25. Delwaide PJ, Pennisi G: Tizanidine and electrophysiologic
Acta Neurol Scand 1992;85:305–10
analysis of spinal control mechanisms in humans with
5. Gracies JM: Physical modalities other than stretch in spastic spasticity. Neurology 1994;44:21–8
hypertonia. Phys Med Rehabil Clin N Am 2001;12:769–92
26. Milanov I: Examination of segmental pathophysiological
6. Alfieri V: Electrical treatment of spasticity: Reflex tonic mechanisms of spasticity. Electromyogr Clin Neurophysiol
activity in hemiplegic patients and selected specific electro 1994;34:73–9
stimulation. Scand J Rehabil Med 1982;14:177–82
27. Macdonell RA, Talalla A, Swash M, et al: Intrathecal ba-
7. Bajd T, Gregoric M, Vodovnik L, et al: Electrical stimulation clofen and the H-reflex. J Neurol Neurosurg Psychiatry
in treating spasticity resulting from spinal cord injury. Arch 1989;52:1110–2
Phys Med Rehabil 1985;66:515–7
28. Joodaki MR, Olyaei GR, Bagheri H: The effects of electrical
8. Hale JL, Chan CWY: Possible enhancement of presynaptic nerve stimulation of the lower extremity on H-reflex and
inhibitory mechanisms following nine days of TENS in hemi- F-wave parameters. Electromyogr Clin Neurophysiol 2001;
plegic patients. Proc Int Union Physiol Sci 1986;16:256–61 4:23–8
9. Levin MF, Hui-Chan CW: Relief of hemiparetic spasticity by 29. Pisano F, Miscio G, Del Conte, C, et al: Quantitative mea-
TENS is associated with improvement in reflex and volun- sures of spasticity in post-stroke patients. Clin Neuro-
tary motor functions. Electroencephalogr Clin Neuro- physiol 2000;111:1015–22
physiol 1992;85:131–42
30. Jin Z, Zhang WT, Luo F, et al: Frequency-specific responses
10. Hui-Chan CW, Levin MF: Stretch reflex latencies in spastic of human brain to peripheral transcutaneous electric nerve
hemiparetic subjects are prolonged after transcutaneous elec- stimulation: A functional magnetic resonance imaging
trical nerve stimulation. Can J Neurol Sci 1993;20:97–106 study. Sheng Li Xue Bao 2001;53:275–80
11. Yu Y: Transcutaneous electric stimulation at acupoints in 31. Kalra A, Urban MO, Sluka KA: Blockade of opioid receptors
the treatment of spinal spasticity: Effects and mechanism. in rostral ventral medulla prevents antihyperalgesia pro-
Zhonghua Yi Xue Za Zhi 1993;73:593–5 duced by transcutaneous electrical nerve stimulation
12. Han JS, Chen XH, Yuan Y, et al: Transcutaneous electrical (TENS). J Pharmacol Exp Ther 2001;298:257–63

592 Aydın et al. Am. J. Phys. Med. Rehabil. ● Vol. 84, No. 8

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