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Effects of Transcutaneous Electrical Acupoint Stimulation On Upper-Limb Impairment After Stroke: A Randomized, Controlled, Single-Blind Trial
Effects of Transcutaneous Electrical Acupoint Stimulation On Upper-Limb Impairment After Stroke: A Randomized, Controlled, Single-Blind Trial
Clinical Rehabilitation
1–12
Effects of transcutaneous electrical © The Author(s) 2022
Abstract
Objective: To evaluate the effects of transcutaneous electrical acupoint stimulation (TEAS) on upper limb
motor recovery during post-stroke rehabilitation.
Design: Single-blind, randomized controlled trial.
Setting: Four inpatient rehabilitation facilities.
Subjects: A total of 204 stroke patients with unilateral upper limb motor impairment were randomly 1:1
allocated to TEAS or sham TEAS group. Baseline demographic and clinical characteristics were comparable
between the two groups.
Interventions: Both groups received conventional physical and occupational therapies. TEAS and sham
TEAS therapy were administered to two acupoints (LI10 and TE5) with a pulse duration of 300 µs at 2
Hz on the affected forearm for 30 times over 6 weeks.
Outcome measures: The upper-extremity Fugl-Meyer score (primary outcome), manual muscle testing,
modified Ashworth scale, Lindmark hand function score, and Barthel index were evaluated by blinded
assessors at baseline, 2, 4, 6, 10, and 18 weeks.
Results: The number of patients who completed the treatment was 99 and 97 in the TEAS and the sham
group. No significant between-group difference was found in the Upper-Extremity Fugl-Meyer score,
1
Department of Rehabilitation, Huashan Hospital, Fudan Corresponding authors:
University, Shanghai, China Yao Chen, Department of Rehabilitation, Shanghai Third
2
Department of Rehabilitation, Shanghai Third Rehabilitation rehabilitation hospital, No. 100 Jiaocheng Road, Jing’an District,
Hospital, Shanghai, China Shanghai 200436, China.
3
Department of Rehabilitation Medicine, South China Hospital, Email: 1995jiangpyn@163.com
Health Science Center, Shenzhen University, Shenzhen, China
4
Department of Epidemiology, School of Public Health, Fudan Jie Jia, Department of Rehabilitation Medicine, Huashan
University, Shanghai, China Hospital, Fudan University, No. 12 Middle Wulumuqi Road,
5
Department of Epidemiology, Key Laboratory of Public Health Shanghai 200040, China.
Safety of Ministry of Education, Shanghai, China Email: shannonjj@126.com
2 Clinical Rehabilitation 0(0)
Modified Ashworth Scale, Lindmark hand function score, and Barthel Index after intervention and during
follow-up. However, the TEAS group exhibited 0.29 (95% CI 0.02 to 0.55) greater improvements in Manual
Muscle Testing of wrist extension than the sham group (p = 0.037) at 18 weeks.
Conclusions: Administration of TEAS therapy to hemiplegic forearm could not improve the upper
extremity motor recovery. However, TEAS on the forearm might provide potential benefits for strength
improvement of the wrist
Keywords
stroke, upper limb, electrical stimulation, acupuncture points, randomized controlled trial
a combination of TEAS therapy and conventional stages I–V in the affected hand; (7) Intact skin on the
rehabilitation methods could produce additional hemiparetic forearm.
benefits to stroke patients with arm and hand The exclusion criteria were: (1) Patients with
motor impairments. We hypothesized that TEAS significant cognitive impairment (MoCA ≤ 24);
might be effective in improving motor function, (2) Severe shoulder or hand pain; (3) Excessive
spasticity, muscle strength, or activities of daily sensory disturbance, aphasia, unilateral neglect, or
living during stroke recovery. apraxia; (4) A history of serious neurological or
psychiatric diseases; (5) A history of alcohol or
drug dependence; (6) Implanted stimulators (such
as cardiac pacemaker); (7) Pregnancy.
Methods All eligible participants who signed written
This study was a randomized, single-blind, con- informed consent were randomized 1:1 to receive
trolled trial conducted in four inpatient rehabilitation TEAS or sham TEAS therapy, using a center-
facilities (two rehabilitation hospitals and two com- stratified randomization procedure by computer-
munity hospitals) in Shanghai, China, from January generated random numbers with SPSS software
1st, 2016 to December 31st, 2018. This study was a (version 25.0, Chicago, IL, USA). Randomization
subproject belonging to a large project named was performed by a physician (YC) who was not
‘Effects of traditional rehabilitation medicine on involved in the recruitment, data collection, and
stroke survivors with hand dysfunction’ funded by treatment of the study. Randomization codes were
the National Science & Technology Pillar Program concealed in sequentially numbered opaque envel-
during the Twelfth Five-year Plan Period. The opes to ensure allocation concealment. The thera-
ethical approval was obtained from the Review pists who delivered the conventional rehabilitation
Board of Ethics Committee of Huashan Hospital therapy and the included patients were masked to
and registered at the Chinese Clinical Trial Registry allocation.
(ChiCTR-IOR-15006102). This study fulfilled the Patients in both groups were subjected to con-
principles of the Declaration of Helsinki, and it was ventional rehabilitation which lasted for 60 min
conducted and reported according to the recommen- per day, 5 days a week for 6 weeks. The conven-
dations of CONSORT guidelines. tional rehabilitation included daily physical and
At each research center, potential participants occupational therapies that were widely accepted,
with unilateral upper limb impairment after stroke individual-specific, and routinely practiced by
were consecutively screened by the physicians experienced therapists in each center. The interven-
(XW, KZ) for eligibility. Study participants were tion, directed at both upper and lower extremities,
all required to sign a written informed consent was aimed at improving skills in basic daily activ-
before enrolment. ities. It combined the techniques of muscle stretch-
Due to recruitment challenges, the original inclu- ing, active/passive mobilization, neuromuscular
sion criteria were modified to include participants facilitation, and task-specific training. All therapists
with a wider age range (increased from 40–80 to received standardized training for consistency
18–85) and onset range (increased from 14 days– before intervention and were not involved in the
12 months to 10 days–2 months). The recruitment group assignment and outcome measurements.
did not begin until the revised inclusion criteria TEAS therapy was administered to two acupoints
were approved by the Review Board of Ethics (LI10 and TE5) on the affected forearm through a
Committee of Shanghai Third Rehabilitation pair of surface electrodes (40 × 26 mm) connected
Hospital. The final inclusion criteria were: (1) to the electrical stimulator (MyoNet-COW, NCC
Medically stable; (2) First-ever cerebrovascular acci- Medical Co Ltd., Shanghai, China) (Figure 1). The
dent; (3) MRI or CT confirmed ischemic or hemor- acupoints selected in this study originated from pre-
rhagic stroke; (4) Stroke onset between 10 days and vious reports on TEAS treatment for motor function
12 months; (5) 18 to 85 years of age; (6) Brunnstrom recovery in individuals with central nervous system
4 Clinical Rehabilitation 0(0)
injuries.11,20 TEAS treatment had a pulse width of use of TEAS equipment before the study
300 µs and a frequency of 2 Hz in the constant intervention.
mode at the maximum tolerable intensity.21 The 2 The study participants were evaluated by two
Hz modality was used because evidence indicated experienced assessors (HW, YX) that were
that low-frequency TEAS could highly activate the blinded to the treatment assignment at baseline,
motor cortex when compared to high frequencies, after every 2 weeks during the treatment period,
such as 100 or 120 Hz, in ischemic stroke patients.22 and at 4 and 12 weeks after completion of treat-
The sham group was administered with an identical ment. Before the assessment, a standardized assess-
treatment, except that the electrical circuit of the ment protocol that included the patient’s position,
stimulator had been internally disconnected. That verbal instruction, and demonstration to the
is, the lights and screen of the stimulator were on, patient was developed. Assessors were obliged to
but there was no real electrical stimulation. follow this standardized protocol and they were
Patients in the sham group were informed that they trained by a senior therapist to ensure that they
might or might not feel mild tingling sensations could perform the assessment in a proper way.
during treatment. TEAS or sham TEAS therapy The primary outcome measure was the
lasted for 30 min per session, 5 days a week for 6 Upper-Extremity Fugl-Meyer score. Secondary
weeks. The stimulation lasted for 30 min per outcome measurements included muscle strength
session because a previous study found that 30 or assessment, muscle spasticity, hand function, and
60 min of neuromuscular electrical stimulation led activities of daily living. The following variables
to similar upper limb motor function improvements were evaluated:
in stroke patients.23 TEAS and sham TEAS therapy
were performed by two experienced physical thera- • The primary outcome measure was the
pists who had received standardized training on the change in the Upper-Extremity Fugl-Meyer
Wang et al. 5
score from baseline to 6 and 18 weeks. It is a appropriate outcome measure for stroke
valid and reliable assessment of upper limb trials and practice.29
impairment both within and between raters
in stroke survivors,24 which consists of 33 The sample size was calculated prior to the start of
items scored on a 3-point (0–2 points) the study using a previously reported method,30
ordinal scale for a maximum possible score based on the assumption that the mean difference
of 66.25 Post hoc outcome measurements between the two groups would be 5 points in the
of the proximal (0–42 points) and distal Upper-Extremity Fugl-Meyer score with a
(0–24 points) subscales were also performed common standard deviation of 12 points in both
to examine the adjacent and remote effects of groups. Furthermore, we assumed that the study
TEAS. would have a dropout of 10%, and the final target
• Muscle strength of wrist flexion and exten- sample size was 204 participants with 102 assigned
sion was measured by Manual Muscle to each group when setting a power of 80% and a
Testing on a scale from 0 (no muscle activ- significance level of 0.05.
ity) to 5 (normal muscle power). Although Data was input by the EpiData software (version
few studies have directly investigated the 3.1, the EpiData Association, JM Lauritsen) after
rater reliability of Manual Muscle Testing double-checking by trained researchers (SC, LD).
in stroke survivors, it has shown excellent All analyses were performed by an independent stat-
inter-rater reliability in trained examiners to istician (YW) using the SPSS software. A modified
assess the grade of muscle weakness in a intention-to-treat analysis was adopted: we analyzed
wide range of pathologies.26 all assigned subjects for whom outcome data at 6
• Wrist flexors spasticity was assessed by weeks were available.30 For missing data, we
measuring resistance to passive wrist exten- moved the last data forward or, if no former value
sion with the Modified Ashworth Scale was available, the next recorded value was used.
scored using a 6-point (0, 1, 1 + , 2, 3, 4) The student’s t-test and chi-square test were per-
scale. This scale has very good intra-rater formed to ensure homogeneity at baseline. The nor-
reliability in the assessment of upper limb mality of data distribution was evaluated using the
spasticity in patients with hemiparesis.27 Kolmogorov–Smirnov statistic. Generalized esti-
• The grasp function of the hand was assessed mating equations (GEEs) were used to estimate the
by a subscale selected from a reliable and effects of treatment between the TEAS group and
valid tool named the Lindmark Motor the sham group on all outcomes. Results are pre-
Score.28 Patients were required to hold a sented as mean and 95% confidence intervals (CIs)
tennis ball with their fingers abducted and and the level of statistical significance was defined
flexed around the ball. It reported using a as α = 0.05 of two-sided probability.
4-point scale: 0 = cannot grasp; 1 = can
grasp but unable to hold against slight resist-
Results
ance; 2 = can hold the ball for 5 s but release
it upon moderate resistance or the grasp Details of participant recruitment, allocation, and
becomes uncoordinated or changed; 3 = follow-up are displayed in the flow diagram
can hold the ball against strong resistance (Figure 2). Out of the 980 stroke survivors who
for 5 s and release it in a normal way. were screened for eligibility, a total of 217 met
• Barthel Index was used to assess the our study criteria, with 204 of them agreeing to
patient’s independence in basic activities of participate in this study. There were no differences
daily living. The original 10-item scale was in baseline demographic, stroke-related, and upper
used for a maximum possible score of 100. limb motor characteristics between the two
Evidence indicates that the Barthel Index groups. The average time from stroke onset at
has excellent inter-rater reliability to be an enrollment was 95.7 days (range, 11 to 349),
6 Clinical Rehabilitation 0(0)
with 72, 92, and 40 patients at acute (35.3%), sub- the TEAS group, however, the between-group
acute (45.1%), and chronic (19.6%) stages. The differences were not significant (difference:
baseline means upper-extremity Fugl-Meyer 1.62 points, 95% CI: −1.16 to 4.40, p =
score was 15.2 (range, 0 to 62), with 154 0.254). Post hoc analysis also did not reveal
(75.5%) patients being severely impaired (0 to any significance in the distal and proximal sub-
22 points)31 (Table 1). scales. At 18 weeks, the between-group differ-
Primary outcome: At the end of treatment, ences in the Upper-Extremity Fugl-Meyer
the mean change in the upper-extremity score and its subscales were still not significant
Fugl-Meyer score from baseline was higher in (Table 2).
Wang et al. 7
Sex
Male 77 (75.5%) 72 (70.6%) 0.430
Female 25 (24.5%) 30 (29.4%)
Age (years) 60.6 ± 12.5 61.9 ± 10.5 0.439
Stroke type
Infarction 68 (66.7%) 71 (69.6%) 0.652
Hemorrhage 34 (33.3%) 31 (30.4%)
Stroke side
Right 60 (58.8%) 56 (54.9%) 0.572
Left 42 (41.2%) 46 (45.1%)
Stroke location
Cortical 13 (12.7%) 13 (12.7%) 0.919
Subcortical 55 (53.9%) 52 (51.0%)
Cerebellar 0 (0.0%) 1 (1.0%)
Brainstem 3 (2.9%) 5 (4.9%)
Multiple 31 (30.4%) 31 (30.4%)
Time since stroke (days) 95.6 ± 97.6 95.7 ± 90.8 0.995
Stage at inclusion
Acute (0–30d) 35 (34.3%) 37 (36.3%) 0.925
Subacute (31–180d) 46 (45.1%) 46 (45.1%)
Chronic (>180d) 21 (20.6%) 19 (18.6%)
Severity at inclusion (FMA-UE)
Mild (48–66) 3 (2.9%) 9 (8.8%) 0.178
Moderate (23–47) 21 (20.6%) 17 (16.7%)
Severe (0–22) 78 (76.5%) 76 (74.5%)
FMA-UE (total) 14.8 ± 12.4 15.6 ± 16.2 0.701
FMA-UE (proximal) 11.5 ± 9.2 11.8 ± 10.8 0.850
FMA-UE (distal) 3.3 ± 5.3 3.8 ± 6.1 0.525
Brunnstrom stage
Arm 2.0 ± 1.1 2.0 ± 1.1 0.950
Hand 1.8 ± 1.1 1.8 ± 1.1 0.854
NIHSS 8.4 ± 4.7 8.6 ± 5.0 0.762
MMT (wrist flexion) 1.0 ± 1.2 1.1 ± 1.4 0.786
MMT (wrist extension) 0.9 ± 1.1 1.0 ± 1.4 0.738
MAS (wrist flexion) 0.8 ± 0.9 0.7 ± 0.8 0.097
Hand function (Lindmark) 0.5 ± 0.8 0.4 ± 0.8 0.486
BI 42.3 ± 17.0 41.3 ± 21.1 0.726
Values are numbers or mean ± standard deviation.
FMA-UE: upper-extremity Fugl-Meyer assessment; NIHSS: National Institute of Health stroke scale; MMT: manual muscle testing; MAS:
modified Ashworth scale; BI: Barthel index.
Secondary outcomes: At 6 weeks, both groups for all these outcomes. At 18 weeks, patients in the
exhibited significant improvements in Manual TEAS group exhibited higher MMT scores in wrist
Muscle Testing scores (wrist flexion/extension), extension when compared to the sham group (dif-
Lindmark hand function scores, and Barthel Index ference: 0.29 points, 95% CI: 0.02 to 0.55, p =
scores when compared to the baseline. However, 0.037). There were no significant between-group
there were no significant between-group differences differences in other outcomes. Regarding wrist
8 Clinical Rehabilitation 0(0)
P value
0.295
0.324
0.349
0.104
0.037
0.205
0.557
0.680
line were found in both groups at 6 and 18 weeks
Mean difference
of the primary outcome within each group
Values are mean (95% CI). FMA-UE: upper-extremity Fugl-Meyer assessment; MMT: manual muscle testing; MAS: modified Ashworth scale; BI: Barthel index.
showed that both groups demonstrated significant
(95% CI)
improvements along the 18 weeks in total (both p
< 0.001), proximal (both p < 0.001), and distal
(both p < 0.001) score of the upper-extremity
(n = 97)
improve the upper limb motor function in stroke
patients. The changes in primary and secondary
outcomes during the 18-week study period com-
TEAS therapy
GEEs analyses did not show any significant
P value (n = 99)
between-group difference.
The TEAS interventions in this study were not
associated with any serious adverse events or side
0.254
0.535
0.131
0.198
0.317
0.363
0.836
0.327
effects. The treatment compliance was excellent,
with a total of 196 (96.1%) participants completing
electrical nerve stimulation has been proved to rehabilitation may not bring additional improve-
improve hand-related function in patients with ments to the upper extremity and hand function.
spinal cord injury33 and stroke.34,35 Prolonged It is also possible that the functional enhancements
periods of peripheral sensory stimulation contri- derived from the TEAS treatment protocol were too
butes to increasing the excitability of the cortico- small to show any significant effect. However, our
motor excitability.36 As a combination of transcuta- result should not be generalized to all stroke popu-
neous electrical nerve stimulation and acupuncture, lations since most participants (75%) had severe
the TEAS is non-invasive and safe,9,20 and it is dysfunction. In future studies, stroke patients with
equipped with built-in therapeutic parameters that mild and moderate upper limb motor impairments
make it standardized in clinical practice.37 To the should be recruited and studied respectively.
best of our knowledge, our study represents the In this study, the only significant between-group
largest clinical trial of TEAS on upper limb recov- difference was noted in Manual Muscle Testing of
ery in stroke patients. wrist extension at 18 weeks. This result suggested
Primary outcome measurements revealed that 6 that TEAS might be beneficial to muscle weakness,
weeks of TEAS intervention brought a mean with the effects being confined to muscles adjacent
improvement of more than 10 points in the upper- to the acupoints that are stimulated. This finding is
extremity Fugl-Meyer scores in both groups. consistent with the results reported by other TEAS
However, the longitudinal analyses showed that studies.9–11 Yan et al.9 found that 3 weeks of daily
the between-group differences were not statistically TEAS treatment at the acute phase to 4 acupoints
significant. Subgroup analysis of proximal and (St36, Lv3, GB34, and Bl60) of the hemiplegic
distal scores of the upper-extremity Fugl-Meyer lower leg significantly increased dorsiflexor
assessment also did not reveal any significant strength. A case study of a chronic stroke patient
between-group difference. This negative finding also showed that a 4-week home program consist-
was consistent with two previous TEAS studies ing of TEAS therapy and task-related training
with similar design.12 Alwhaibi et al.12 compared could effectively improve dorsiflexor strength,
the therapeutic effects of TEAS (applied to LI11 gait velocity, and walking edurance.10 There are
and LI4) and sham TEAS on upper limb motor several possible mechanisms. First, the LI10 and
recovery in chronic stroke patients. The results TE5 acupoints are adjacent to extensor carpi radia-
indicated that adding TEAS to task-specific training lis and finger extensors, respectively. Six weeks of
did not further improve the upper-extremity low-frequency electrical stimulation might partially
Fugl-Meyer score and Box and Block Test reverse or slow down the atrophy process of these
Interestingly, the activity of the motor area (C3) two muscles.38–40 Second, previous studies
in the TEAS group increased significantly com- reported that prolonged peripheral electrical stimu-
pared with the sham group, suggesting that the lation leads to reinforced sensory inputs to the
degree of cortical remodeling was not enough to sensory cortical representation, which may facili-
cause significant changes in motor recovery. In tate motor outputs of the muscles innervated by
another study conducted by Christina et al., 73 these sensory-motor areas.22,41 However, whether
stroke patients were randomized to TEAS acupoint stimulation of the LI10 and TE5 during
(applied to LI4, LI10, LI11, and LI15), TEAS therapy can improve muscle strength in
placebo-TEAS, and control group.11 The results stroke survivors through a mechanism different
showed that all between-group differences in from transcutaneous electrical nerve stimulation
Action Research Arm Test and hand strength remains to be further studied.
were not significant except that the TEAS group In this study, there were no statistical
demonstrated greater improvements in hand grip between-group differences in other outcomes.
and pinch strength than the control group. In sum, Although previous TEAS studies reported some
based on our findings and previous evidence, we positive results in relieving spasticity in patients
suggest that adding TEAS to conventional with brain damage,9,10,18 they all applied 100 Hz
10 Clinical Rehabilitation 0(0)
rather than 2 Hz electrical stimulation. Direct evi- Research Arm Test should also be included in the
dence is from a randomized controlled trial in future.
brain injury patients which showed that 4 weeks
of TEAS at 100 Hz to four acupoints (L14,
LU10, ST36, and BL57) could significantly Clinical messages
relieve wrist spasticity while 2 Hz and sham
TEAS therapy did not.18 In addition, the TEAS • Adding 6 weeks of TEAS therapy to two
group did not show any superiority in the acupoints (LI10 and TE5) on the affected
Lindmark hand function test and Barthel Index. forearm did not bring additional benefits
It is probably attributed to the floor effects of to upper extremity motor recovery as mea-
these two scales since 75% of participants were sured by the upper-extremity Fugl-Meyer
with severe impairments. Moreover, the relatively score in stroke patients.
wide standard deviations might be another reason • TEAS therapy might contribute to the
for these negative results. improvement of arm muscle strength with
The strengths of this study included the high the effects being confined to muscles adja-
compliance rates, extended follow-up period, cent to the acupoints that are stimulated.
and the absence of adverse events. However, this • Future studies should investigate the influ-
study is also associated with several limitations. ence of the treatment dose and acupoints
Although the sample size was based on statistical compatibility on TEAS therapy in stroke
calculation, the relatively loose inclusion criteria patients with mild and moderate impair-
caused large standard deviations in all outcomes. ments, respectively.
In addition, this study demonstrated the ceiling
effect for some outcomes. Furthermore, the treat-
ment dose, defined as the combination of different Acknowledgments
parameters including treatment frequency, inten- The authors thank all patients and therapists who partici-
sity, and duration, should also be investigated.23 pated in the study.
Lastly, according to the theory of acupoint com-
patibility, when two or more acupoints are Declaration of Conflicting Interests
selected, the synergy between the acupoints is The author(s) declared no potential conflicts of interest
strengthened.42 After we compared all the posi- with respect to the research, authorship, and/or publica-
tive and negative studies of TEAS on stroke tion of this article.
rehabilitation, we found that the compatibility
of four acupoints demonstrated greater effects Funding
than two acupoints.8–12 Thus, future studies This trial was financially supported in part by the General
should evaluate the optimum compatibility of Research Project of Shanghai Municipal Health and
acupoints.32 Family Planning Commission (Grant Nos. 202040034
In conclusion, adding 6 weeks of TEAS therapy and 201540197); in part by the Medical research
(applied to LI10 and TE5) to conventional rehabili- project of Shanghai Jing’an District Health
tation could not improve the upper extremity motor Commission and District Science and Technology
recovery in stroke patients. However, our study Commission (Grant No. 2020MS17); in part by the
Key Subjects Construction Program of the Health
found positive effects of TEAS on the strength of
System in Jing’an District (No. 2021PY04); in part by
wrist extension at 12 weeks after treatment comple- the National Key R&D Program of China (Grant No.
tion. Future studies should investigate the effects of 2018YFC2002301); in part by the China National
different treatment doses and acupoints compatibil- Nature Science Young Foundation (Grant No.
ities in patients with mild and moderate impair- 82102665); and in part by Shanghai Sailing Program
ments, respectively. More sensitive assessments (No. 21YF1404600). The authors have no financial con-
such as Wolf Motor Function Test or Action flicts of interest.
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