Chang et al.

BMC Musculoskeletal Disorders 2014, 15:399

http://www.biomedcentral.com/1471-2474/15/399

RESEARCH ARTICLE Open Access

Comparative effectiveness of ultrasound and

paraffin therapy in patients with carpal tunnel
syndrome: a randomized trial
Yi-Wei Chang1, Shih-Fu Hsieh3, Yu-Shiow Horng1, Hui-Ling Chen1, Kun-Chang Lee1 and Yi-Shiung Horng1,2*

Abstract
Background: Conclusive evidence indicating an effective treatment for carpal tunnel syndrome (CTS), a common
entrapment neuropathy, is lacking. Ultrasound therapy (US therapy) has long been used as one of the combination
treatments for CTS. In addition, paraffin bath therapy has been applied widely as a physical modality in treating
patients with hand conditions. The purpose of this randomized trial was to compare the efficacy of combining a wrist
orthosis with either US therapy or paraffin bath therapy in treating CTS patients.
Methods: Patients with CTS were randomized into two groups. All patients received a wrist orthosis. Twice per week,
one group underwent paraffin therapy, and the other group underwent ultrasound therapy. Each patient received a
questionnaire, physical examination and nerve conduction study of the upper extremities before and after treatment
for eight weeks.
Results: Sixty patients were recruited, and 47 completed the study. Statistical analysis revealed significant improvements
in symptom severity scores in both groups. After adjusting for age, gender and baseline data, the analysis of covariance
revealed a significant difference in the functional status score between two groups.
Conclusions: The combination of ultrasound therapy with a wrist orthosis may be more effective than paraffin therapy
with a wrist orthosis.
Trial registration: Clinicaltrial.gov: NCT02278289 Oct 28, 2014
Keywords: Carpal tunnel syndrome, Paraffin therapy, Ultrasound therapy

Background For years, US therapy has been used as one of the com-
Carpal tunnel syndrome (CTS) is a common entrapment bination treatments for CTS [1-3,5]. The mechanism of
neuropathy that causes symptoms of pain, numbness and US therapy includes thermal and nonthermal effects. The
paresthesia in the distribution of the median nerve and thermal effect occurs when acoustic waves penetrate the
may even cause atrophy of the thenar muscle [1,2]. For tissue and produce molecular vibration, which results in
patients with mild to moderate symptoms, nonsurgical heat production and facilitates pain relief. [6] The non-
treatments, such as local steroid injection, oral medica- thermal effect of US therapy includes cavitation, media
tion, wrist orthoses, therapeutic exercise, ultrasound ther- motion and standing waves, which might elicit anti-
apy (US therapy), low-level laser and paraffin bath have inflammatory and tissue-stimulating effects [7,8]. Several
been implemented clinically [1,3,4]. However, conclusive clinical trials have revealed US therapy has a positive effect
evidence on the best treatment for patients with CTS is on patients with CTS [5,9]. However, Cochrane’s 2013 re-
lacking. view concluded that there is still insufficient evidence to
support that US therapy is more effective than placebo or
other nonsurgical interventions for CTS [10]. Additional
* Correspondence: d97841001@gmail.com
1
Department of Physical Medicine and Rehabilitation, Taipei Tzuchi Hospital, research is still needed to compare the effectiveness of US
Buddhist Tzuchi Medical Foundation, New Taipei City, Taiwan therapy with other modalities for patients with CTS, par-
2
Department of Medicine, Tzu Chi University, Hualien, Taiwan ticularly in the long term.
Full list of author information is available at the end of the article

© 2014 Chang et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain
Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article,
unless otherwise stated.
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Paraffin therapy has been widely used as a physical were administered by physical therapists who did not par-
modality in treating patients with hand conditions, such ticipate in evaluating the study outcome.
as rheumatoid arthritis, osteoarthritis and CTS [4,11,12]. The participants were randomly allocated into two
Paraffin therapy provides superficial heat to the hands, groups. One group received paraffin therapy and a wrist
which can both relieve pain and improve local circula- orthosis, and the other group received US therapy and a
tion [6,13]. Previous studies have revealed that paraffin wrist orthosis. Custom-made neutral wrist orthoses were
therapy could improve pain and finger joint range of given to all the patients, who were instructed to wear
motion in patients with hand arthritis [11,12]. Symptom the wrist orthoses while sleeping for at least eight weeks.
improvements were also observed in patients with CTS A CONSORT flowchart describing the process of par-
after receiving combination treatments with paraffin ticipant randomization and intervention is depicted in
therapy and a wrist orthosis [4]. However, to the best of Figure 1.
our knowledge, no previous clinical trial has compared A series of physical examinations and nerve conduc-
the effectiveness of paraffin bath with US therapy for tion studies (NCSs) were performed on each patient.
CTS patients. Physical examination included the palmar pinch power
test, the Semmes-Weinstein Monofilament sensory test,
Tinel’s test and Phalen’s test. Participants completed a
Purpose
set of questionnaires, including the Boston CTS ques-
The purpose of this exploratory study is to compare the
tionnaire and several questions involving basic demo-
combination of a wrist orthosis with either US therapy
graphic information. Numbness and pain were assessed
or paraffin bath therapy in the treatment of CTS pa-
using a 10-cm visual analog scale (VAS).
tients. We hypothesized that US therapy might be more
After receiving the designated 8-week therapy, all pa-
effective than paraffin therapy because it provides both
tients were re-evaluated using the same clinical examina-
thermal and nonthermal effects.
tions, questionnaires and NCSs. The outcomes of the
physical examination and the NCSs were assessed by
Methods physiatrists who were not aware of the group assignments.
Patients and controls
The Institutional Review Board of our hospital (Taipei
Paraffin therapy
Tzuchi Hospital Institutional Review Board Committee)
Patients in the paraffin therapy group were treated with
approved this study, and patients provided informed
the dip-and-wrap method of paraffin bath therapy in the
consent prior to the study. Sixty individuals diagnosed
hospital twice per week for 8 weeks. The temperature of
with CTS were recruited from the Department of Phys-
the paraffin bath was maintained at approximately 55°C
ical Medicine and Rehabilitation in one community hos-
(Parabath, Hygenic Corporation, Akron, OH, USA). The
pital during 2010 and 2011. Study inclusion criteria
whole procedure is described as follows. Patients dipped
required patients to have subjective symptoms (such as
their affected hands into the paraffin wax. Next, they
pain and/or numbness in the median nerve distribution
waited for the paraffin wax to harden and then dipped
of the digits or nocturnal pain). Furthermore, patients
their hands again into the paraffin wax. This step was re-
were required to have either a positive Phalen’s sign or a
peated 5 times. When the last paraffin layer hardened, it
positive Tinel’s sign along with electrophysiological evi-
was covered with plastic wrap and a towel. After 20 mi-
dence of CTS. We excluded patients with (1) age younger
nutes of heating, the paraffin was removed [12].
than 18 years old; (2) underlying medical disorders, such
as diabetes mellitus, renal failure, autoimmune disease or
hypothyroidism; and (3) pregnancy, previous wrist trauma Ultrasound therapy
or surgery. Patients in the ultrasound group were treated with US
All eligible patients were invited, and the participants therapy for 5 minutes each session, twice per week for
were randomly assigned to two groups. A total of 60 lots 8 weeks. The US machine was set at a frequency of
were prepared with 30 lots for each group, and each lot 1 MHz, an intensity of 1.0 W/cm2, in pulsed mode (1:4)
was sealed in a non-transparent envelope with the same with a transducer 5 cm2 in size (Therasound 3.5, Rich-
appearance. All envelopes were randomly mixed together Mar Corporation, Inola, OK, USA), and with aquasonic
numerous times. Finally, the envelopes were marked from gel as couplant [3]. The transducer was placed over the
1 to 60 by an assistant who was not involved in the mixing wrist carpal tunnel area, ranging from wrist crease to
process, and the study nurse simply picked up the lot se- palmar region. A stroking method was used with a
quentially. The allocations were concealed with the use of sonation area of approximately 5 × 5 cm2. The machine
packages of prescription orders, which were given by the was calibrated, and the output was adjusted regularly
nurse to the physical therapists, and the therapy programs with a simple underwater balance.
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Figure 1 Flowchart of patients’ recruitment.

Outcome measurements power and the distal sensory and motor latencies of the
The patients were evaluated with the Boston CTS ques- median nerve.
tionnaire, a pain scale, physical examinations and NCSs
before and after treatment for eight weeks. Physical examinations
Phalen’s test was performed by asking the patients to
Primary outcome fully flex their wrist for 60 seconds. A positive test oc-
The primary outcome was the functional status scale of curred when patients experienced symptoms of numb-
the Boston CTS questionnaire. The Boston CTS question- ness and tingling in the median nerve distribution [15].
naire is a self-administered outcome measurement for Tinel’s sign was elicited by gently tapping the median
CTS patients, consisting of two parts: a symptom severity nerve at wrist level. This test was considered positive
scale (11 questions) and a functional status scale (8 ques- when patients reported signs of a tingling sensation or
tions). All of the answers were scored from 1 to 5 accord- shooting pain along the median nerve distribution of the
ing to the patient’s clinical condition, such that 1 indicated hand [16]. Palmar pinch strength was measured by
no symptoms, and 5 indicated the most severe symptoms. pressing the thumb and the index finger tip against a
The questionnaire’s reproducibility, internal consistency standard dynamometer. This procedure was repeated 3
and responsiveness were validated in the previous paper times, and a mean score was obtained [17].
[14]. The functional status scale of the Boston CTS ques- The Semmes-Weinstein monofilament sensory test
tionnaire was chosen as the primary outcome because it is was measured by applying force-calibrated nylon fila-
closely correlated with the patient’s ability to perform daily ment to the fingertips with the wrist in a neutral supine
activities. The goal of rehabilitation is to improve the func- position. Each type of filament was pressed perpendicu-
tional status of patients, rather than only symptom relief. larly against the fingertips until the filament bent into a
C shape. This examination was considered positive if the
Secondary outcomes patient was able to correctly identify which digit the
The secondary outcomes were the symptom severity monofilament was touching with his/her eyes closed. A
scale of the Boston CTS questionnaire, the pain scale, weighted score from 1 to 5 was acquired according to
changes in the monofilament sensory test, palmar pinch each filament’s calculated force [14]. We recorded the
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scores from seven sample areas in each hand and summed distribution of responses in each cluster, while considering
the scores to analyze as a continuous variable. that these examinations were performed on both hands
for those patients who had bilateral CTS; this GEE
Nerve conduction study method was applied with the subjects as clusters, and in
Median and ulnar nerve sensorimotor NCSs were con- this model, the two hands of each individual were treated
ducted on all patients utilizing Neuropack M1 MEB- as correlated [23]; and (5) the differences in changes in
9200 J/K electrodiagnostic equipment (Nihon Kohden the physical examination and NCS data between the two
Corporation, Tokyo, Japan) in a quiet, air-conditioned studied groups using the GEE model, with age, sex and
room (26°C). The patients were prepared in the supine baseline values as covariates. In addition, we calculated
position with their skin temperature measured on the the effect size (ES; mean changes in scores divided by
palms and maintained above 32°C. Standard techniques baseline standard deviation) for PROs. All of the statistical
of supramaximal percutaneous stimulation with a con- analyses were performed using the SAS statistical software
stant current stimulator and surface recording were used package, version 9.2. (SAS Institute Inc., Cary, NC, USA).
for the NCS. Median motor nerve conduction and distal
motor latency were measured by placing a stimulating
electrode at the wrist and a recording electrode on the Results
abductor pollicis brevis muscle 8 cm from the stimulus Patient characteristics and patient-reported outcomes
electrode. A standard distance (14 cm) was maintained Seventy-eight patients were enrolled in this study, and 18
between the stimulator and recording electrodes for the patients were excluded after being assessed for eligibility.
sensory nerve conduction studies [18]. The ring finger Among the excluded patients, nine did not meet the in-
difference was calculated as the median nerve peak latency clusion criteria and nine declined to participate. A total of
minus the ulnar nerve peak latency [19]. The diagnosis 60 patients with CTS were recruited and randomized into
of CTS was established if at least one of three criteria the two study groups. Forty-seven patients completed the
was achieved: (1) distal motor latency >4.4 millisec- study. Seven and six patients were unable to complete the
onds, (2) distal sensory latency >3.4 milliseconds [20] study in the paraffin and US therapy groups, respect-
or (3) median-ulnar distal sensory latency difference ively (Figure 1). Table 1 summarizes the demographic
(ring difference) >0.4 milliseconds [19].
Table 1 Frequency distributions (percentages) of
Sample size demographic characteristics in patients with CTS who
For sample size estimation, previous randomized, con- completed the study
trolled trial studies, conducted in CTS patients receiving Treatment group
carpal tunnel injection, suggested that 26 subjects per Characteristics Paraffin therapy US therapy
group would provide 90% statistical power and a 5% sig- n = 23, n (%) n = 24, n (%)
nificance level by two-sided tests to detect a significant Personal characteristics
decrease in the Boston CTS questionnaire score from
Age, mean±SD, yrs 51.9±8.8 48.8±11.2
1.6 to 2.0 [21,22]. To compensate for a 15 to 20% drop-
Body mass index, mean±SD 25.7±4.5 25.0±3.7
out rates, we recruited 30 subjects per group.
Male 3 (13.0) 2 (8.3)
Married 17 (77.3) 17 (70.8)
Statistical analysis
The following data were analyzed: (1) descriptive statis- Employed 10 (40.5) 14 (58.3)
tics to summarize the participants' basic demographics; Smoking habit 0 (0.0) 1 (4.2)
(2) the baseline and follow-up scores for patient- Right-hand dominant 21 (95.5) 23 (100.0)
reported outcomes (PROs; including the symptom severity Bilateral hands involved 20 (87.0) 17 (70.8)
scale, the functional status scale and pain intensity), using Educational level
paired t-tests for each patient; (3) the differences in
College/University 7 (30.4) 9 (37.5)
changes in the PROs after treatment between the groups
by analysis of covariance (ANCOVA), with adjustments Senior High 8 (34.8) 11 (45.8)
for age, sex and the baseline data for each item before Junior High or below 8 (34.8) 4 (16.7)
treatment to accommodate individual differences; (4) the Household monthly income (US$)
baseline and follow-up physical examinations and NCS <1200 8 (34.8) 3 (12.5)
data for each affected hand, using the generalized estimate 1200-3500 10 (43.5) 16 (66.7)
equation (GEE) method, which is a quasi-likelihood ap-
>3500 5 (21.7) 5 (20.8)
proach for correlated data that does not fully specify the
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characteristics and basic participant information. As Table 3 Comparison of the results of physical examinations
shown in Table 1, the mean ages of the patients in the and NCSs in CTS patients
paraffin and US therapy groups were 51.9 ± 8.8 and Treatment group P valueb
48.8 ± 11.2 years, respectively. More than half of the pa- Paraffin therapy US therapy
tients were female and had bilateral CTS. (n = 43) (n = 37)
After treatment, significant improvements in symptom Monofilament test 0.95
severity scores were seen in both groups (Table 2). The
BT 29.5±3.7 30.1±4.1
effect size (ES) of the symptom severity scores was 0.63
AT 30.7±3.0 30.9±2.7
for both groups. However, significant improvements in
functional status scores (ES 0.38) and pain scales (ES Difference (AT-BT) 1.2±3.5 1.2±3.3
a
0.74) were only seen in the US therapy group. An effect P value 0.03 0.05
size of 0.3 to 0.8 is considered a "moderate" effect [24]. Palmar pinch power (kg) 0.34
After adjusting for age, gender and baseline data, the BT 3.2±1.8 3.2±1.2
ANCOVA analysis revealed significant differences in the
AT 3.6±1.5 3.6±1.1
functional status scores between the two study groups.
Difference (AT-BT) 0.4±1.8 0.5±1.4
P valuea 0.44 0.01
Physical findings and NCSs Distal motor latency of 0.06
A significant improvement in the monofilament sensory the median nerve (ms)
test was observed in the paraffin group, and a significant BT 5.10±1.27 5.11±1.34
improvement in the palmar pinch power test was ob- AT 4.98±1.51 5.08±1.30
served in the US therapy group as well (Table 3). How- Difference (AT-BT) -0.3±0.6 -0.03±0.6
ever, NCSs did not detect significant changes in the P value a
0.77 0.91
Distal sensory latency of
Table 2 Comparison of the CTS Questionnaire and the the median nerve (ms)
pain scale in CTS patients
BT 3.7±0.9 3.6±0.8 0.83
Treatment group P valueb
AT 3.4±0.8 3.6±1.4
Paraffin therapy US therapy
Difference (AT-BT) -0.2±0.9 0.03±1.1
(n = 23) (n = 24)
Functional status score 0.04 P valuea 0.11 0.91
Abbreviations: CTS carpal tunnel syndrome; NCS nerve conduction study; US
BT 1.7±0.6 1.8±0.8
ultrasound; BT before treatment; AT after treatment.
a
AT 1.8±0.9 1.6±0.7 Paired t test (generalized estimating equation).
b
Comparison of differences in changes after treatment between groups after
Difference (AT-BT) 0.1±0.9 -0.3±0.4 adjusting for age, gender and baseline values (generalized estimating equation).
Effect size 0.17 0.38
P value a
0.88 0.0017 distal motor or sensory latencies of the median nerve in
Symptom severity score 0.51 either group. Despite adjusting for baseline data, age and
BT 2.5±0.8 2.6±0.8
sex, there were no significant differences between the
two study groups in any of the outcomes of the physical
AT 1.9±0.7 2.1±0.8
examinations or NCSs (Table 3).
Difference (AT-BT) -0.5±0.7 -0.5±0.7
Effect size 0.63 0.63
P value a
<0.0001 0.0046 Discussion
Pain scale 0.81 In this study, we found that US therapy tends to be
BT 56.3±20.9 68.3±19.3
more effective than paraffin therapy in treating CTS pa-
tients. Patients who underwent US therapy and a wrist
AT 50.7±22.7 54.2±22.6
orthosis not only experienced improvements in their
Difference (AT-BT) -5.7±24.1 -14.2±27.3 functional status scores compared to those receiving
Effect size 0.27 0.74 paraffin therapy and a wrist orthosis but also showed
P value a
0.29 0.01 statistically significant improvements in their symptom
Abbreviations: CTS carpal tunnel syndrome; US ultrasound; BT before treatment; severity scores and palmar pinch power. In contrast, pa-
AT after treatment.
a
tients who underwent paraffin therapy and a wrist orth-
Paired t test.
b
ANCOVA comparison of differences in changes after treatment between groups
osis only experienced significant improvements in their
after adjusting for age, gender and baseline values. symptom severity scores.
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Different modes, frequencies and intensities have been and in the monofilament sensory test, consistent with a
used in US therapy for CTS patients [1,3,5,9,25,26]. Gen- previous study [4]. These findings could be regarded as a
erally, in US therapy, continuous mode is chosen when validation of the baseline measurements of this trial. In
the thermal effect is desired, while pulsed mode is ap- the US therapy group, a significant improvement in
plied when the nonthermal effect is preferred [13]. Al- pinch power was noted, in addition to symptom im-
though the study conducted by Dincer et al. revealed provements, which further improved patients' functional
symptom improvements after continuous mode US ther- status. This result might be partially contributed by the
apy in CTS patients [9], Oztas et al. reported a pro- nonthermal effect of pulsed US therapy.
longed distal motor latency and a decrease in motor Though it requires more manpower to implement US
nerve conduction velocity after treatment with continu- therapy than paraffin therapy, combination treatment
ous mode US therapy [26]. These findings implied that with US therapy and a wrist orthosis is recommended
though continuous mode US therapy was able to im- because of its superior effect on functional status and
prove the symptoms in CTS patients, selective heating possibly on nerve regeneration. Further study to com-
of the median nerve might lead to temporal conduction pare the effectiveness of pulsed vs. continuous US ther-
block [26]. On the contrary, pulsed mode US therapy ef- apy in CTS patients is suggested.
fectively enhanced peripheral nerve regeneration in an This study has several limitations. First, because this
animal study, possibly through the mechanisms of local study was performed in the Department of Physical
blood vessel dilatation, nerve sprouting stimulation, Medicine and Rehabilitation, the patients usually suf-
Schwann cell activation and chemotactic stimulator re- fered from mild to moderate symptoms. Therefore, we
lease [27]. should remain cautious in our attempts to generalize
This study utilized pulsed mode US therapy on CTS pa- our findings to patients with more severe symptoms.
tients and observed improvements in subjective symptoms Second, this study used a combination treatment of a
and palmar pinch power, similar to previous studies [1,3]. wrist orthosis with either US or paraffin therapy because
However, we did not note significant improvements in dis- it would have been unethical to withhold wrist orthoses
tal motor and sensory latencies of the median nerve after when they have been reported to be effective [9]. There-
eight weeks of treatment. These findings corroborate stud- fore, the treatment effects might partially originate from
ies conducted by Yildiz et al. and Baysal et al., who were the wrist orthoses. Third, because approximately 20% of
also unable to find significant improvement in distal laten- the participants did not complete this study, we could
cies of the median nerve in CTS patients after applying not perform the intention-to-treat analyses. To examine
pulsed mode US therapy and followed up for eight weeks the potential bias caused by loss of follow-up, we com-
[3,25]. This negative result might be because A fibers in pared the demographic and baseline symptoms severity
the peripheral nerve system are measured mostly in clin- scales, functional status scores and pain scales between
ical NCSs, but C fibers, which transmit somatic pain sig- the patients who completed the study and those who did
nals, are more sensitive to US effects than A fibers not. The results revealed no significant differences be-
[6,28,29]. This difference might explain the fact that, des- tween the follow-up and non-follow-up groups. Thus,
pite significant symptom improvements in our study, we believe the potential bias may be minimal because all
NCSs did not detect significant improvements in distal patients were instructed in the same manner and were
motor and sensory latencies of the median nerve. More- randomized into two different groups. Fourth, because
over, delayed recovery of nervous tissue could contribute this study compared the two studied groups regarding
to the lack of improvement seen in NCSs. As shown in their functions, symptoms, pain and results on four clin-
Harris et al.’s study, CTS patients who underwent surgical ical tests, we were concerned about multiplicity issues.
decompression experienced delayed electrophysiological Of the 7 outcomes evaluated, only the primary outcome
recovery of up to six months [30]. Inadequate follow-up (functional status score) exhibited a significant difference
time may underestimate the electrophysiological improve- between the two studied groups. Thus, further random-
ment; thus, further study with a longer follow-up time is ized, controlled trials with long-term follow-ups could
recommended. be needed to validate these results.
Paraffin therapy is a superficial heat physical agent that
uses conduction to transfer heat. Its therapeutic effects Conclusions
include increasing blood flow, producing analgesic ef- To improve the functional status of CTS patients, a
fects, decreasing chronic inflammation, improving con- combination of ultrasound therapy and a wrist orthosis
nective tissue elasticity and stimulating general muscle may be more effective than a combination of paraffin
relaxation [6,31]. In this study, patients receiving a com- therapy and a wrist orthosis. Since this is an exploratory
bination treatment of paraffin therapy and a wrist orth- trial, further confirmatory testing is suggested to justify
osis exhibited improvements in symptom severity scores the efficacy of these two treatments.
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Abbreviations 12. Dilek B, Gozum M, Sahin E, Baydar M, Ergor G, El O, Bircan C, Gulbahar S:

CTS: Carpal tunnel syndrome; US therapy: Ultrasound therapy; NCSs: Nerve Efficacy of paraffin bath therapy in hand osteoarthritis: a single-blinded
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and data analysis, revised the manuscript and acted as the corresponding 17. Brininger TL, Rogers JC, Holm MB, Baker NA, Li Z-M, Goitz RJ: Efficacy of a
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