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Reduction in Spasticity in Stroke Patient With Paraffin Therapy

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Neurological Research

A Journal of Progress in Neurosurgery, Neurology and Neurosciences

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

Reduction in spasticity in stroke patient with


paraffin therapy

Jing Wang, Peng Yu, Ming Zeng, Xudong Gu, Yan Liu & Mingyue Xiao

To cite this article: Jing Wang, Peng Yu, Ming Zeng, Xudong Gu, Yan Liu & Mingyue Xiao (2016):
Reduction in spasticity in stroke patient with paraffin therapy, Neurological Research

To link to this article: http://dx.doi.org/10.1080/01616412.2016.1248169

Published online: 23 Nov 2016.

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Download by: [University of Regina] Date: 24 November 2016, At: 04:41


Neurological Research, 2016
http://dx.doi.org/10.1080/01616412.2016.1248169

Reduction in spasticity in stroke patient with paraffin therapy


Jing Wanga,b†, Peng Yuc,d†, Ming Zenge, Xudong Gue, Yan Liua and Mingyue Xiaoa
a
Department of Rehabilitation Medicine, Beijing United Family Rehabilitation Hospital, Beijing, China; bDepartment of Rehabilitation
Medicine, Taikang Yanyuan Rehabilitation Hospital, Beijing, China; cDepartment of Anethesiology, Beijing Puhua international hospital,
Beijing, China; dDepartment of Pain Medicine, Kunming LiH Skycity Rehabilitation Hospital, Kunming, China; eDepartment of Rehabilitation
Medicine, The Second Affiliated Hospital of Jiaxing University, Jiaxing, China

ABSTRACT ARTICLE HISTORY


Purpose: The aim of the study was to confirm whether paraffin therapy offer clinical value in the Received 25 May 2016
treatment of spasticity due to stroke. Accepted 9 October 2016
Methods: Fifty-two patients with spasticity in the upper limb were included. The patients KEYWORDS
were randomized into the experimental group with paraffin therapy (n = 27) and the control Stroke; spasticity; paraffin
group with placebo therapy (n = 25). The outcome measures besides temperature examination therapy; modified ashworth
were undertaken at time points of 0 (T0), 2 (T1) and 4 weeks (T2) following therapy treatment. score; visual analogue scale
The extent of spasticity was measured using Modified Ashworth Score (MAS) during passive
movement at the shoulder, elbow, wrist and finger joints. Visual analogue scale (VAS) was used
to evaluate the hemiplegic upper limb pain and functional activity of the upper limb motor
function was evaluated by Brunnstrom recovery stage. All adverse events were recorded.
Results: MAS decreased significantly in Exp group compared with Con group, at the time points
of T1 and T2, both before and immediately after paraffin therapy. Paraffin treatment failed to
show remarkable improvement in pain compared with placebo-treated patient at movement
at any time point. But VAS in Exp exhibited a tendency to decrease over time in shoulder,
elbow, wrist and hand. With regard to the Brunnstrom score, patients in Exp showed significant
improvement at the end of trial compared to the beginning. The values of temperature showed
significant increment immediately after paraffin therapy at each time point in Exp group.
Conclusion: Paraffin therapy may be a kind of noninvasive, promising method to reduce
spasticity of stroke patients.

Introduction surgical therapy.[5] There are many oral medications


Stroke is the third leading cause of death in most that could reduce stretch reflexes (diazepam, baclofen,
developed countries.[1] Stroke may raise lesions of the tizanidine, dantrolene, etc.).[6] Mechanisms of anti-spasm
pyramidal tract and its accompanying parapyramidal drugs are different. Some drugs affect the peripheral
fibres which give rise to the upper motor neuron neuromuscular sites (Phenol, Botulinum toxin, etc.),
(UMN) syndrome.[2] Spasticity, which is characterized other drugs act on neurotransmitters or neuromodulators
by velocity-dependent increase in stretch reflexes within the central nervous system (CNS).[7] The effects
with exaggerated tendon jerks, is a common positive of oral antispastic medications often were short duration
phenomenon with a rate of 20% or higher.[3] It is well and most of them lead to side effects such as weakness,
recognized that spasticity after stroke may lead to many drowsiness, confusion, dizziness, sedation and dry mouth.
negative consequences, for example, hypertonia in the [8,9] Oral drugs may produce the effect on anti-spasm,
antigravity muscles.[4] Abnormal postures may be but the side effect of them may limit their tolerance
formed in the limb by hypertonia consequently, such as and efficacy.[9] Some drugs have been proposed (such
an adducted posture at the shoulder and a flexed posture as baclofen, benzodiazepines, tricyclic antidepressants,
at the elbow and wrist, and the fingers flexed into the dantrolene and tizanidine) to have a concomitant
palm.[5] Abnormal posture of the lower limb may cause depressing effect on the CNS.[9] However, none has been
difficulty in seating and transferring,[5] which could proved to be useful in reducing disability due to stroke.
result in decline in the quality of a patient’s life. Local infiltrations of alcohol and phenol have shown
Various techniques for the management of spasticity effect (2–36 months) on spasticity in stroke patients, but
have been proposed, including oral drugs, local they are painful and have low selectivity.[10] Botulinum
infiltrations, physical therapy, occupational therapy and toxin type A (BTA) has proven effective in the treatment

CONTACT  Jing Wang  [email protected]



These author contributed equally to this work.
© 2016 Informa UK Limited, trading as Taylor & Francis Group
2   J. WANG ET AL.

of focal spasticity after stroke, with the disadvantages Table 1. Subject characteristics of each group.
including short duration of action, and risk of weakness Variables Total Exp Con P value
in distant non-targeted muscle because of diffusion of Age, years
toxin through fascial boundaries and systemic spread. Mean(SD) 68.65 (8.34) 70.04 (8.08) 67.16 (8.51) 0.217
Range 54–82 57–81 54–82
[11] Some studies usually combine pharmacological Gender(M/F) 34/18 16/11 18/7 0.392
and physical interventions to treat stroke patients with Type of 41/11 20/7 21/4 0.503
stroke(I/H)
spasticity.[12] Evidence for direct effective anti-spasticity Paretic 30/22 14/13 16/9 0.413
effects of each therapy method is limited. side(L/R)
There are few studies evaluating the effect of thermal Time since
stroke, days
therapy on patients with spasticity. Matsumoto et al. Mean(SD) 108.31 113.78 102.40 0.212
demonstrated that spasticity decreased after the use of (32.61) (34.27) (30.28)
Range 62–179 62–179 65–176
thermal therapy (footbath) which indicated decreased
F-wave parameters and decreases in the Modified Note: SD, standard deviation; M, male; F, female; I, infarction; H, haemor-
rage; R, right; L, left.
Ashworth Score (MAS).[13] Chen et al. discovered
that thermal intervention significantly increased the
outcomes of Brunnstrom stage, wrist extension and Table 2. MAS scores of two groups at follow-up (n = 52).
sensation.[14] Paraffin wax therapy, one kind of heat T0 T1 T2
therapy, has been in general use in hospital.[15] The local Exp(n = 27,Mean(SD))
paraffin wax bath has been used for the treatment of Before 2.28(0.54) 1.67(0.55) 1.35(0.57)
After 2.17(0.73) 0.98(0.61) 0.74(0.61)
osteoarthritis patients.[16,17] A preliminary study was in Con (n = 25,Mean(SD))
favour of using paraffin and hand exercises as a treatment Before 2.08(0.57) 2.20(0.54) 2.58(0.53)
After 2.08(0.57) 2.24(0.50) 2.50(0.54)
to improve hand function related to participation in Between subjects
daily activities in persons with scleroderma.[18] As (P Value)
Before 0.21 <0.01 <0.01
far as we know, no study has investigated the effects of After 0.64 <0.01 <0.01
paraffin therapy on spasticity due to stroke. In order to
Note: MAS, Modified Ashworth Scale; SD, standard deviation; T0, the first
confirm whether paraffin therapy offer clinical value in treatment; T1, 2  weeks after treatment; T2, 4  weeks after treatment;
the treatment of spasticity, a comprehensive assessment Before, before paraffin therapy in Exp and placebo therapy in Con;
of the anti-spastic effects of paraffin is required. After, after paraffin therapy in Exp and placebo therapy in Con. Between
subjects, the analysis of values over time between Exp and Con group.

Materials and methods patients were diagnosed with cerebral infarction and 11
Study population with cerebral haemorrhage. Left hemiplegia occurred in
30 patients, and 22 patients had right hemiplegia. The
Fifty-five patients with spasticity in the upper limb were mean time since stroke onset was 108.31 ± 32.61 days
recruited from Rehabilitation Medicine Center, Jiaxing (range, 62–179 days) (Table 1), and the mean MAS score
Second Hospital, Jiaxing, Zhejiang. Two patients didn’t for spasm was 2.18 ± .56 in two cases (Table 2).
meet the inclusion criteria. One patient withdrew Stroke diagnosis was based on computed tomography
during the study. Thus, 52 patients with a mean age of (CT) or magnetic resonance imaging (MRI), as well as
68.65 ± 8.34 years (range 54–82 years) completed the neurological function tests. Patients met the following
study. Each patient had first stroke. The sample size was inclusion criteria: (1) defined a first-ever stroke (cerebral
calculated that a minimum of 24 patients were required haemorrhage or infarction) according to the World
in each study group, to have an alpha risk of 0.05 and Health Organization (WHO) criteria;[19] (2) spasticity of
a beta risk of 20% on a bilateral contrast, based on a the upper limb; (3) no cognition problem and able to give
mean difference in change score of >0.15 (standard informed consent; (4) stable medical condition. Exclusion
deviation (SD) of 0.23) in Modified Ashworth Score criteria were as follows: (1) any other neurological
(MAS) between the two groups, and the sample size disorders that might affect muscle tone, (2) transient
was overestimated in order to allow for up to 10% of ischaemic attack and (3) subarachnoid haemorrhage. All
potential drop-outs. Randomization allocation numbers patients were informed about the experimental procedures
generated by a computer were put in sealed envelopes, and its risks and signed their consent. The protocol was
which were held by an individual not involved with reviewed and approved by the ethics committee of the
the study. After giving informed consent, patients were Jiaxing University and Medical Centre.
assigned by a random number to two groups with a
1:1 proportion. The patients were blinded to group
Preparation of paraffin pieces
assignment. The patients were randomized into the
experimental group with paraffin therapy (n = 27) and The method of making paraffin pieces were as follows:
the control group with placebo therapy (n  =  25). Of firstly, paraffin wax was prepared and the selected
the 52 patients (including 34 males and 18 females), 41 melting point of 52–54 °C of refined paraffin wax was
NEUROLOGICAL RESEARCH   3

put into computer thermostat paraffin wax treatment and any changes in medication and all adverse events
device (BA2008-HWL, Fujian, China). Secondly, ladle were recorded.
molten paraffin wax was put into the special enamel
• MAS for spasticity: the extent of spasticity was
tray , the thickness of liquid wax about 2 cm, leaving
measured using MAS during passive movement at the
the liquid wax to be naturally cooled till the surface
shoulder, elbow, wrist and finger joints.[20] The MAS
temperature of 45–50 °C. The inside of paraffin pieces
uses a five-point scale to score the average resistance
was still half-liquid even though solidification was
to passive movement for each joint. The MAS of 0
found in the outer layer of paraffin pieces. Then the
indicates no increase in muscle tone, while the MAS
paraffin pieces were separated from the edge of the
of 4 indicate that the affected part(s) is rigid in flexion
enamel tray with a small thin shovel, and then the tray
or extension. To facilitate data analysis, MAS scores
was buckled onto a large plastic sheet. A light knock
(0, 1, 1+, 2, 3 and 4) were assigned numerical values,
at the bottom of the tray could make the wax cake
respectively. A score of 1 + was assigned the value of
prolapse. The placebo paraffin pieces as control were
1.5. The scores for spasticity at the shoulder, elbow,
made of sand pack with comparable weight of the par-
wrist and fingers were summed to produce a composite
affin wax.
spasticity score.[21] MAS was measured before and
after paraffin therapy/false paraffin therapy at the
Paraffin therapy procedure time points of T0, T1 and T2. To increase reliability,
The detailed method of applying the paraffin therapy only one experienced physical therapist performed a
was described below. Firstly, patients were informed to blinded MAS measurement during all test trials.
remove all jewellery prior to treatment, wash and dry •Visual analogue scale (VAS) for pain: A 100 mm-VAS
the paretic upper limbs. Secondly, the subject was kept was used to evaluate the hemiplegic upper limb pain
in a supine position, and made sure that clothing was associated with spasticity in the shoulder, elbow,
well out of the way of treatment area and the body part wrist and hand, performing passive range-of-motion
to be treated was relaxed. Thirdly, the prepared paraffin (ROM) exercises at the time points of T0, T1 and T2.
pieces were picked up to cover the hemiplegic upper The VAS score 0 was defined as no pain and a score
limb (from shoulder to hand), and the paraffin pieces of 100 as severe pain.[22]
were covered with plastic wrap first and then lightweight •Functional activity of the upper limb motor
towels to retain heat longer. Lastly, the paraffin pieces function was evaluated by Brunnstrom recovery
were removed after 30  min, meanwhile a soft towel stage according to the original descriptions.[23] The
was used to wipe to ensure that all the paraffin is com- lowest stage, no voluntary movements in the affected
pletely removed. The thickness of paraffin pieces was limb, was stage 1, and the highest stage, control and
2–3 cm, and the surface temperature of paraffin pieces coordination near normal, was stage 6. Brunnstrom
was 40–42 °C which was safe and medically accepted. was videotaped by one of the investigators and
Patients in experiment group (Exp) received paraffin assessed at the end of the study by two independent
therapy firstly everyday (30 min a day, 5 days a week). raters who were not involved in the study. All raters
Other general treatments were performed after applying got same training of Brunnstrom.
paraffin therapy. •Temperature examination: body temperature was
The treatment notes were as follows: (1) Explain to monitored before and after paraffin therapy. A body
patients that the body may rise response, and inform thermometer, 124 × 18 × 11 mm in shape (medical
patients not to squeeze the wax cake during the wax electronic thermometer, YT303, Yu Yue, Jiangsu,
treatment; (2) Check whether there are sensory distur- China), was placed under the tongue, and the patient
bances in patient’s skin, paraffin temperature should be was asked to close the mouth, breathe through the
appropriately reduced if the patient has sensory dys- nose and use the lips to hold the thermometer tightly
function, the temperature of paraffin usually was 45 °C; in place. The thermometer remained in the mouth for
(3) Carefully measure the temperature of paraffin wax 2 min or until the device beeped.
before treatment; (4) Layer of 1 to 2 sterile gauze can
be on broken skin, and then for treatment and (5) If Statistical analysis
treatment of adverse reactions or skin allergy occurs,
treatment should be stopped. Quantitative variables are given as the mean ± SD, and
categorical variables are given in absolute values. In
the case of quantitative variables, the assumption of
Outcome measurement
normality was analysed by the normal probability graphs,
The outcome measures besides temperature examination and all variables were in normal distribution. One-way
were undertaken at time points of 0 (T0), 2 (T1) and analysis of variance (ANOVA) was applied to compare
4 weeks (T2) following therapy treatment. The number differences in quantitative variables (age, time since
of physical therapy and/or occupational therapy sessions stroke), and χ2 test was used for categorical variables
4   J. WANG ET AL.

(gender, type of stroke, paretic side). Analysis of variance 78.8% patients who presented ischaemic strokes with a
was performed using a repeated-measures mixed design slight predominance of left hemiparesis (30 vs. 22). The
(intra-group) and multivariate test (inter-groups) for mean time since stroke were 113.78 (SD, 34.27) days in
the analysis of values over time. When the sphericity Exp group and 102.40 (SD, 30.28) days in Con group.
criteria were not complied with, the degrees of freedom
were corrected using Mauchly’s test. P value below 0.05 The result of MAS
was considered statistically significant. Analyses were
performed using the Scientific Package for the Social MAS decreased significantly in Exp group compared with
Sciences (SPSS), version 18.0 (SPSS, Charite, Germany). Con group, at the time points of T1 and T2, both before
and immediately after paraffin therapy (Table 2 and
Figure 2(A)). There was no significant difference about
Results
MAS before and immediately after paraffin/ placebo
Subject characteristics of each group therapy at the time point of T0 in both groups (p > 0.05),
then MAS in Exp decreased significantly after paraffin
The experimental procedure is described in Figure 1.
therapy compared with before paraffin therapy at the
There were 55 eligible patients in the trial, of them 2
time point of T1 and T2 (p < 0.05). MAS values in Exp
patients didn’t meet the inclusion criteria. Therefore,
decreased below baseline values after paraffin treatment
53 patients were randomized to trial (27 in Exp, 26 in
at the time points of T1 and T2 (p < 0.05). There were no
Con), and 1 patient in Con was excluded during the
significant differences about MAS before and immediately
study, because the patient claimed to be treated by
after placebo therapy at any time points in Con (p > 0.05),
traditional medicine and declined to participate further
but the values showed a tendency to increase over time in
in the study. The final sample was 52 patients (27 in Exp
Con. MAS at T2 increased significantly compared with
and 25 in Con). The demographic data of two groups
any other time points (p < 0.05, Table 2).
were summarized in Table 1. There were no statistically
significant differences between the groups regarding
demographic characteristics which included age, gender, The result of VAS
type of stroke, side of hemiplegia and time since stroke. The scores of VAS are shown in Table 3 and Figure
The mean age was 70.04 (SD, 8.08) years in Exp group 2(B). Mean VAS on shoulder, elbow, wrist and hand of
and 67.16 (SD, 8.51) years in Con group; male was more passive mobilization were 38.85 (SD, 10.41), 35.38(SD,
common than female in the gender distribution (65.4% 9.99), 30.00(SD, 13.14), 30.19 (SD, 13.36) mm separately
vs. 34.6%, respectively) of these 52 patients, but similar at the time point of T0, with no significant difference
proportion of gender was in two groups. There were in VAS between the groups at each time point (T0, T1
and T2). Each patient with spasticity in the trial endured
different extent of pain during passive mobilization.
Table 3 provides data of pain for all patients with the
movement of shoulder, elbow, wrist and hand. Paraffin
treatment failed to show remarkable improvement in
pain compared with placebo-treated patient at movement
at any time point. But VAS in Exp exhibited a tendency to
decrease over time on shoulder, elbow, wrist and hand,
with mean shoulder VAS of 39.63 (2.03) at T0, 38.15
(1.85) at T1, and 37.41 (1.89) at T2 (Table 3). Values of
shoulder, wrist and hand in Exp group showed significant
reduction in pain levels at both T1 and T2 compared to
T0 (p < 0.05), and there was marked difference in VAS on
elbow at the time point of T1 compared with T2. VAS in
Con showed a slight tendency to increase over time on
each part, Values of elbow, wrist and hand in Con group
showed significant increase in pain levels at both T1 and
T2 compared to T0 (p < 0.05), and with no difference in
the shoulder among time points T0 (p > 0.05).

The result of Brunnstrom


As shown in Figure 2(C), there was no difference between
two groups at baseline (T0), with mean Brunnstrom
Figure 1. Diagram showing participant flow and retention. score 3.15 (SD, 0.09) in Exp and 3.20 (SD, 0.10). All
NEUROLOGICAL RESEARCH   5

Figure 2. The tendency of MAS, VAS, Brunnstrom scores, and temperature (°C) of two groups at follow-up (n = 52). (A), tendency
of MAS. (B), tendency of VAS. (C), tendency of Brunnstrom scores. (D), temperature (°C). MAS, Modified Ashworth Scale; VAS: visual
analogue scale; Brunnstrom: Brunnstrom recovery stage used to evaluate upper limb motor function; SE, standard error; the scores
are shown as mean (SE); T0B, before the first treatment; T0A, after the first treatment; T1B, before paraffin therapy at the time point of
2 weeks; T1A, after paraffin therapy at the time point of 2 weeks; T2B, before paraffin therapy at the time point of 4 week; T2A, after
paraffin therapy at the time point of 4 weeks.

measures displayed no significant differences between 36.76 (SD, 0.17) at T0, 36.47 (SD, 0.13) vs. 36.75 (SD,
two groups at each time point (p  >  0.05). Moreover, 0.12) at T1 and 36.49 (SD, 0.17) vs. 36.77 (SD, 0.16) at
patients in Exp showed significant improvement at T2 (p < 0.05). There were no differences between before
the end of trial compared to the beginning (from 3.15 therapy and after therapy at any time points in Con
(SD, 0.09) to 3.30 (SD, 0.10), p < 0.05). We didn’t find group. No obvious differences were observed between
significant difference in intra-subject of Con. two groups before paraffin therapy at each time point,
but after paraffin therapy, temperature in Exp increased
The change in temperature significantly compared with Con group (p < 0.05).

As shown in Figure 2(D), there was no difference between


Therapy sessions and concomitant treatment
two groups at the beginning of study. The values of tem-
perature showed significant increment immediately after In the Exp, there was 1 patient who missed therapy
paraffin therapy compared to before paraffin therapy at sessions (physical, occupational therapy and paraffin
each time point in Exp group with 36.48 (SD, 0.17) vs. therapy) for one time because of fever. Two patients in
6   J. WANG ET AL.

Table 3. VAS scores of two groups at follow-up (n = 52).


T0 T1 T2
Exp (n = 27,Mean(SD))
Shoulder 39.63 (10.55) 38.15 (9.62) 37.41 (9.84)
Elbow 35.93 (9.31) 34.81 (9.76) 34.44 (10.13)
Wrist 31.11(12.81) 29.26 (12.99) 29.26(12.99)
Hand 30.74(14.39) 29.26(14.12) 28.89(14.50)
Con (n = 27,Mean(SD))
Shoulder 38.00 (10.41) 38.40 (10.28) 39.60 (10.20)
Elbow 34.80 (10.847) 36.80 (9.883) 38.00 (9.57)
Wrist 28.80(13.64) 30.40 (12.41) 32.00(11.55)
Hand 29.60(12.41) 31.20(12.36) 32.00(12.91)
Between subjects (P value)
Shoulder 0.58 0.93 0.43
Elbow 0.69 0.47 0.20
Wrist 0.53 0.75 0.43
Hand 0.76 0.60 0.42

Note: VAS: visual analogue scale; SD, standard deviation; T0, the first treatment; T1, 2 weeks after treatment; T2, 4 weeks after treatment; Between subjects,
the analysis of values over time between Exp and Con group.

Table 4. Therapy sessions of two groups during the study. Table 5. Summary of treatment-related adverse events during
Therapy sessions
the trial.
(times) Exp (times = 540) Con (times = 500) Adverse events
PT 539 498 n (%) Exp (n = 27) Con (n = 25) Total (n = 52)
OT 539 498 Increased blood 2 (7.4) 5 (20) 7 (13)
Paraffin 539 0 pressurea
Placebo paraffin 0 498 Vomiting 0 (0) 0 (0) 0 (0)
Increased painb 0 (0) 15 (60)* 15 (29)
Note: PT, physical therapy; OT, occupational therapy; paraffin, paraffin ther-
Scaldc 0 (0) 0 (0) 0 (0)
apy; Placebo paraffin, placebo paraffin therapy.
Skin diseased 1 (3.7) 0 (0) 1 (2)
Deaths 0 (0) 0 (0) 0 (0)

the Con didn’t receive physical therapy and occupational


a
Increased blood pressure, the blood pressure increased compared before
paraffin therapy. bIncreased pain occurred on affected upper limb. cScald,
therapy sessions separately for one time, one for increased observation of the scald during and after paraffin therapy. dSkin disease,
pain in the shoulders, and the other for increased blood skin allergies. *P < 0.05.
pressure. There were no obvious patterns in concomitant
medications which were stopped or started during the
trial (Table 4). analysis was performed. VAS in Exp showed a tendency
to decrease gradually over time on shoulder, elbow, wrist
and hand, moreover, there was significant reduction in
Adverse events pain levels of shoulder, wrist and hand in Exp group,
In the study, increased blood pressure occurred 7.4% at 2 and 4  weeks after paraffin therapy compared to
in Exp, and 20% in Con, with 60% increased pain in baseline (p < 0.05), and VAS on elbow presented marked
Con, which is higher in levels compared to pain than reduction at 4  weeks after treatment compared with
Exp (0%). Totally 3.7% Skin disease (skin allergies) was the baseline (p < 0.05). However, VAS in Con showed
present in Exp, no in Con. There were no instances of a slight tendency to increase over time on each part.
vomiting, scald, respiratory failure, heart failure or no Accordingly, paraffin therapy played an important role
deaths (Table 5). in alleviating the pain of upper limb in Exp group. But
we still need to extend the study to evaluate the impact
of paraffin therapy on pain, and pain was not prominent
Discussion
among the study population and the groups were not
In this study, paraffin therapy presented effective in terms well matched with respect to pain at baseline.
of reducing spasticity of upper limb in stroke patients, This study was a well-randomized double-blind
which is the primary purpose of this study. Moreover, clinical trial, but it is difficult to design the appropriate
pain and upper limb motor function were observed after control group in studying paraffin therapy effect on
paraffin therapy by VAS and Brunnstrom, respectively. patients. When paraffin therapy is being administrated,
However, paraffin therapy failed to demonstrate the it is a problem to blind the patients to their group
significant benefit in improving functional activity of allocation. In this study, a room-temperature sand pack
the upper limb motor function using the Brunnstrom. of comparable weight was placed on the spasticity upper
Besides, there was no consistent difference in reduction limb in Con group, covered with towels. In a pragmatic
in pain. study, it is appropriate to establish the effects of adding
However, in order to study the tendency of pain and paraffin therapy to standard treatment. This will give
upper limb motor function within the group, intra-group valuable information about the likely clinical impact of
NEUROLOGICAL RESEARCH   7

the interventions, but it may be difficult to determine cortex and basal ganglia through functional magnetic
the mechanism of paraffin therapy. resonance imaging.[30] The study demonstrated that
Paraffin wax is white translucent, tasteless, odourless, thermal pain may uniquely activate brain areas which
chemically stable and extremely heavy in molecular were in the secondary somatosensory region, insula
structure, with melting point 50–60 °C. Melted paraffin and posterior cingulate cortex.[31] The simultaneous
wax absorbs a lot of heat, heat may be released slowly activation of many brain areas may be helpful for
during cooling, 1  kg of melting paraffin solidification facilitating the reduction in spasticity.
may release an average of 39 calories. Paraffin has been To our limited knowledge, it is the first study to
laboratory tested to be hygienically safe to use.[24] investigate the effects of paraffin therapy on spasticity
There are kinds of benefits of paraffin therapy. Because due to stroke. In the study, paraffin therapy presented
paraffin wax has large thermal capacity, thermal storage effective in terms of reducing spasticity of upper limb
and small thermal conductivity, and does not contain in stroke patients. Although there were no significant
water and other liquids, and there is no convection differences about MAS between two groups, patients
phenomenon. These characteristics make the wax in Exp showed significant improvement of MAS at
warm the body to produce a strong role through the the end of trial compared to the beginning, with no
warm effect in promoting blood circulation.[17] Since difference in intra-subject of Con. In the study, the
paraffin is heavy in molecular weight, it also increases VAS of shoulder were 39.63 (10.55) in Exp and 38.00
the blood supply to the area being treated. The plasticity (10.41) in Con, with higher score than other joints. The
and viscosity of paraffin brings it close in contact with VAS in each joint of upper limb observed in Exp group
the skin; and in the process of cooling and solidification, presented a tendency to decrease gradually over time.
shrinkage of paraffin in the volume may generate effect Moreover, compared with the beginning of study, there
of mechanical pressure, and accelerate the absorption was significant reduction in pain levels of shoulder, wrist
of oedema, also help transfer heat to the deep tissue. and hand in Exp group, at 2 and 4 weeks after paraffin
[25] In addition, mechanical pressure can also increase therapy (p < 0.05). However, the same tendency of VAS
the role of extensibility of collagen tissue, soften scars was not observed in Con, on the contrary, the VAS of
and adhesions of connective tissue, but also make the Con displayed the trend of slight raise. So we inferred
skin increase the elasticity and flexibility.[25] So paraffin that paraffin therapy may play an important role in
therapy may make contracture of joints to improve range alleviating the pain of upper limb in Exp group.
of motion. One of the benefits in using paraffin therapy Spasticity reflects a more severe motor disorder that
is easy to operate. Moreover, paraffin materials are very is clearly associated with disability.[32] The Brunnstrom
easy to buy. Thus, the modalities of paraffin therapy are staging system can reflect underlying motor control
not only increasingly being used in rehabilitation and based on clinical assessment of movement quality.[33]
therapy clinics, but also can be considered as a part of Evidence has shown that the Brunnstrom recovery
home therapy programme for stroke patients.[26] In stages are moderately correlated with neurophysiological
the study, we found that a short-term paraffin therapy measures and highly concerned with the Modified
(30  min daily) could reduce spasticity, which could Modified Ashworth Scale (MMAS) regarding the
maximize the effect of physical and/or occupational evaluation of motor recovery in stroke patients.[34]
therapy within the therapeutic period, then lower the Higher Brunnstrom scores indicate better motor
loading of the family and patients themselves. recovery.[33,35] In this study, the Brunnstrom motor
Although the primary lesion leading to spasticity lies evaluation scale was applied to assess the recovery in
within the central nervous system, the structure and motor functions. According to statistical results, the
function of skeletal muscle in patients with spasticity are difference in Brunnstrom between two groups was
also dramatically changed.[27] A study measured the not significant. Moreover, patients in Exp showed
stiffness of muscle fibres and sarcomere lengths significant improvement at the end of trial compared to
and found that the muscle fibres from patients with the beginning, but there was no significant difference
spasticity were over twice as stiff as the fibres from the in intra-subject of Con. The upper limb motor function
patients without spasticity.[28] In the study, reduction could be improved after the treatment of paraffin
of ­spasticity was presented after paraffin therapy which therapy in Exp group, suggesting that paraffin therapy
belonged to warm stimulus. However, the neuronal is helpful for recovery of motor function. However, the
processes underlying the improved outcome and change results should be verified using other measurement tool
in spastic muscle were not explored. A study discovered for motor function after stroke, such as Fugl-Meyer
that noxious hot (46°) stimulation can activate several Assessment (FMA),[36] and Action Research Arm test.
brain areas, which were cingulate, somatosensory, [37] On the other hand, in the study, paraffin pieces
premotor and motor cortices, as well as prefrontal and were applied to the affected limb, with the temperature
inferior parietal cortex.[29] Furthermore, warm related of 40–42 °C. The temperature can be controlled by the
activation areas were found in the thalamus, insular computer thermostat paraffin wax treatment device.
8   J. WANG ET AL.

We found that the values of temperature increased   [2] Burne J, Carleton V, O’dwyer N. The spasticity paradox:
about 0.28 °C after paraffin therapy compared to before movement disorder or disorder of resting limbs?
paraffin therapy at each time point in Exp group. The J Neurol Neurosurg Psychiatry. 2005;76(1):47–54.
 [3]  Lundström E, Terer V, O’dwyer N. The spasticity
temperature range of 40–42 °C is safe for stroke patients. paradox: movement disorder or disorde-ever stroke.
This study had several limitations. Firstly, although an Eur J Neurol. 2008;15(6):533–9.
intention-to-treat analysis had been used to make sure the  [4]  Gracies J-M, Brashear A, Jech R, McAllister P,
minimal sample size of 24 patients in each group for MAS, Banach M, Valkovic P, et al. Safety and efficacy of
the small sample size placed the study at risk for a type II abobotulinumtoxinA for hemiparesis in adults with
upper limb spasticity after stroke or traumatic brain
error limited the generalization of the results to the broader
injury: a double-blind randomised controlled trial.
stroke population. More patients should be included in Lancet Neurol. 2015;14(10):992–1001.
the further study to avoid the fault. Secondly, although the  [5] Bethoux F. Spasticity management after stroke. Phys
baselines of VAS and Brunnstrom measurements in both Med Reh Clin N. 2015;26(4):625–39.
groups are not statistically significant, pain and upper   [6] Abbruzzese G. The medical management of spasticity.
limb motor function were not prominent measurements Eur J Neurol. 2002;9(s1):30–4.
  [7] Gracies JM, Nance P, Elovic E, McGuire J, Simpson DM.
among the study population and the groups were not well Traditional pharmacological treatments for spasticity
matched with respect to them at baseline. So well-matched part II: general and regional treatments. Muscle Nerve.
groups about these parameters should be taken to observe 1997;20(S6):92–120.
the effect of paraffin therapy on pain or motor function   [8] Gallichio JE. Pharmacologic management of spasticity
in the further study. Finally, there was no remarkable following stroke. Phys Ther. 2004;84(10):973–81.
  [9] Chou R, Peterson K, Helfand M. Comparative efficacy
reduction in pain using the VAS inter-subjects, but with
and safety of skeletal muscle relaxants for spasticity and
a tendency to decrease gradually in Exp group and to musculoskeletal conditions: a systematic review. J Pain
increase over time in Con separately. A similar conclusion Symptom Manage. 2004;28(2):140–75.
could be achieved by Brunnstrom. This suggests the time [10] Zafonte R, Munin M. Phenol and alcohol blocks for
of study should be extended to observe much longer effect the treatment of spasticity. Phys Med Reh Clin N.
of paraffin therapy on pain and motor function of upper 2001;12(4):817–32.
[11]  Bhakta BB, Cozens JA, Chamberlain MA, Bamford
limb in stroke patients. JM. Impact of botulinum toxin type a on disability
In summary, this study showed that paraffin therapy and carer burden due to arm spasticity after stroke:
is a kind of noninvasive, promising method to reduce a randomised double blind placebo controlled trial.
spasticity of stroke patients. Given the multifactorial J Neurol Neurosurg Psychiatry. 2000;69(2):217–21.
origin of spasticity, a successful strategy would most [12]  Turner-Stokes L, Ward A. Botulinum toxin in the
management of spasticity in adults. Clin Med (Lond).
likely require a combination of interventions to achieve
2002;2(2):128–30.
the best clinical outcome. Further investigations are [13] Matsumoto S, Shimodozono M, Etoh S, Shimozono Y,
warranted to confirm the results and to evaluate Tanaka N, Kawahira K. Beneficial effects of footbaths
the effects of paraffin therapy on spasticity of stroke in controlling spasticity after stroke. Int J Biometeorol.
patients. 2010;54(4):465–73.
[14] Chen JC, Liang CC, Shaw FZ. Facilitation of sensory
and motor recovery by thermal intervention for the
Conflict of interest hemiplegic upper limb in acute stroke patients. Stroke.
2006;36(12):2665–9.
All authors declare that they have no conflict of interest [15]  Dilek B, Gözüm M, Şahin E, Baydar M, Ergör G,
to state. El Ö, et al. Efficacy of paraffin bath therapy in hand
osteoarthritis: a single-blinded randomized controlled
trial. Arch Phys Med Rehabil. 2013;94(4):642–9.
Funding [16] Mai V, Birkenfeldt R, Übner M. An evaluation of the
effect of differing lengths of spa therapy upon patients
This work was financially supported by Special fund for
with osteoarthritis (OA). Complementary Ther Clin
medical service of Jilin finance department [grant num-
Pract. 2008;14(1):60–4.
ber SCZSY201507]; National Natural Science Foundation
[17] Myrer JW, Johnson AW, Mitchell UH, Measom GJ,
of China [grant number 81201504]; Zhejiang Provincial
Fellingham GW. Topical analgesic added to paraffin
National Science Foundation of China [grant number
enhances paraffin bath treatment of individuals with
LY12H17004].
hand osteoarthritis. Disabil Rehabil. 2011;33(6):
467–74.
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