Acupuncture For Upper-Extremity Rehabilitation in Chronic Stroke: A Randomized Sham-Controlled Study
Acupuncture For Upper-Extremity Rehabilitation in Chronic Stroke: A Randomized Sham-Controlled Study
Acupuncture For Upper-Extremity Rehabilitation in Chronic Stroke: A Randomized Sham-Controlled Study
ORIGINAL ARTICLE
intensity, transcutaneous electronic nerve stimulation,17 or needles inserted shallowly at traditional acupoints19 as controls.
Because the mechanisms underlying acupuncture are still
poorly understood, particularly how acupuncture might benefit
recovery from hemiparesis, it is unclear whether these sham
treatments are truly inert.20-22
A second limiting aspect of studies of acupuncture in stroke
patients is that many have used standardized acupuncture
points in all subjects.17,19,23 The use of fixed, standardized
prescriptions for acupuncture points deviates from traditional
Chinese medicine (TCM) theory, which postulates that stroke
survivors comprised a diversity of TCM diagnostic classes,
each with different stroke etiologies and symptoms.24-26 Accordingly, TCM proposes that optimal treatment should use a
unique acupuncture protocol for each diagnostic class. Therefore, studies that have used standardized treatments may not
have effectively tested the benefits of acupuncture as it is
clinically practiced.27,28 To evaluate the benefits of acupuncture for chronic stroke symptoms, and to address important
methodologic issues, we compared the efficacy of an active,
individualized, TCM-based protocol with a sham protocol in
which a validated sham acupuncture needle device was
used.29-31 Our study was designed to collect data with which to
assess whether active acupuncture improves upper-extremity
(UE) range of motion (ROM), spasticity, and motor function;
and to assess whether active acupuncture improves ADLs,
quality of life (QOL), and mood.
METHODS
Study Design
This study was a 2-arm RCT with blinding of patients and
assessors, but not acupuncturists. Patient recruitment was coordinated through Spaulding Rehabilitation Hospitals Stroke
Service and targeted people in the greater Boston area. Recruitment included use of hospital databases; letters to local hospital
neurologists, nursing homes, and stroke support group leaders;
and newspaper advertising.
To be eligible, patients were required to have moderate UE
dysfunction from a first stroke incurred at least 6 months
earlier. Moderate UE dysfunction was defined as at least some
weakness or functional limitation, but not so severe as to
prevent a patient from being able to raise the impaired arm
from a hanging position to a tabletop while seated (knees 15.2
cm [6in] under table). Other inclusion criteria were the ability
to arise independently from a chair and the ability to walk
independently with or without a cane or walker. Exclusion
criteria were: (1) previous experience with acupuncture; (2)
contraindications to electroacupuncture, including wearing of
pacemakers or embedded neural stimulators, cardiac arrhythmia, epilepsy, or women who were pregnant or trying to
conceive32,33; (3) comorbidities that would prohibit participation in study procedures, including active renal dialysis, metastatic cancer, or extremity fracture within the past 6 months;
(4) simultaneous participation in other forms of physical or
occupational therapy; (5) enrollment in other studies that involved active interventions; or (6) cognitive impairment that
would interfere with ones ability to give informed consent.
Two independent institutional review boards approved the
study.
Study Procedures
Patients deemed eligible from an initial phone screening
were scheduled for an enrollment interview at the New England School of Acupuncture, during which the studys objec-
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and 64% in the sham group indicated they were not certain
whether they were receiving active or sham therapy. Only 28%
correctly guessed their assignment. Responses to the masking
questionnaire did not differ by actual treatment assignment
(Fisher exact test, P.71). After completing all treatments,
only 35% of subjects who completed the instrument correctly
guessed their true assignment, and again, responses did not
differ by treatment assignment (Fisher exact test, P.32).
Efficacy of Acupuncture on UE Motor Function,
Spasticity, and ROM
In the ITT analyses, no UE function measure differed significantly between 2 treatment groups after controlling for
baseline values of each measure, baseline FMA, dexterity, and
log-transformed time since stroke (table 3). In the per-protocol
analyses, however, several 12-week change measures favored
the active treatment group, including Ashworth wrist scores
(P.01); shoulder ROM through the frontal plane (P.01);
and wrist ROM in the sagittal and frontal planes (P.01) (see
table 3, fig 2). FMA (P.09) and digit ROM (P.06) showed
trends toward improvements in the per-protocol active group
relative to the sham group.
Fig 1. Flow diagram of subject progress through the trial.
All (N33)
Active (n16)
Sham (n17)
Age (y)
Sex (% male)
Race (% white)
Time since stroke (mo)
Dexterity (% high)
Barthel Index
NHP
CES-D
FMA
Three jaw chuck
Ashworth: elbow
Ashworth: wrist
ROM shoulder
Sagittal plane
Frontal plane
Transverse plane
ROM elbow: sagittal plane
ROM forearm: transverse plane
ROM wrist
Sagittal plane
Frontal plane
ROM thumb
ROM digits
59 (2889)
73
78
53 (10292)
52
63 (2889)
75
75
66 (12292)
44
95
86
5.8
31
6.1
1.7
1.6
54 (4269)
71
76
41 (10123)
59
97
87
5.1
36
7.7
2.3
1.8
0.09
1.00
1.00
0.18
0.49
0.62
0.54
0.48
0.76
0.31
0.18
0.54
123
143
85
119
140
131
149
95
105
138
0.74
0.64
0.67
0.17
0.48
91
40
48
58
83
37
52
63
0.54
0.82
0.99
0.97
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Group Assigned
Active
Sham
Not Sure
2-wk
Active
Sham
Active
Sham
15
14
13
10
47 (7)
29 (4)
46 (6)
30 (3)
7 (1)
7 (1)
38 (5)
20 (2)
47 (7)
64 (9)
15 (2)
50 (5)
.71
3-mo
.32
Table 3: Efficacy of Acupuncture on UE Motor Function, Spasticity, and ROM After 12 Weeks
ITT
2
Per-Protocol
Adj R (%)
Effect*
95% CI
.98
.74
.22
.25
49.5
29.1
62.3
6.2
3.12
1.05
1.27
0.5
0.6 to 6.9
2.6 to 0.5
2.2 to 0.3
7.3 to 6.3
.09
.16
.01*
.87
26.9 to 30.3
12.0 to 53.5
4.3 to 43.6
17.0 to 14.1
45.0 to 57.5
.90
.20
.10
.85
.80
47.2
57.7
6.9
80.9
24.3
22.59
49.40
24.79
9.10
45.66
12.6 to 57.8
13.5 to 85.3
16.0 to 65.6
12.5 to 30.7
39.3 to 131.0
.18
.01*
.20
.36
.25
17.1 to 53.5
2.6 to 23.5
8.1 to 10.4
3.2 to 17.0
.29
.11
.79
.17
60.8
71.7
62.6
41.7
42.68
18.46
5.34
10.84
13.2 to 72.2
5.0 to 31.9
3.9 to 14.5
0.5 to 22.2
.01*
.01*
.21
.06
Measure
Adj R (%)
Effect*
95% CI
FMA
Ashworth: elbow
Ashworth: wrist
Three jaw chuck
ROM
ROM shoulder
Sagittal plane
Frontal plane
Transverse plane
ROM elbow: sagittal plane
ROM forearm: transverse plane
ROM wrist
Sagittal plane
Frontal plane
ROM thumb
ROM digits
13.3
5.7
33.9
5.7
0.05
0.20
0.57
2.22
4.2 to 4.1
1.4 to 1.0
1.5 to 0.4
6.2 to 1.7
43.5
28.0
19.6
71.1
13.1
1.70
20.71
19.65
1.46
6.25
18.1
54.9
9.6
2.6
18.20
10.47
1.15
6.91
The stated P values are not corrected for the number of outcome measures analyzed.
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Fig 2. Least-square means estimates and 95% confidence intervals of change from baseline for per-protocol subjects. (A) ADL, mood
function, strength, and UE spasticity. (B) ROM. Abbreviation: A, active treatment; NS, not significant; S, sham treatment. Note that the scales
for CES-D and Ashworth scores have been inverted so that all measures show improvements to the right and declines to the left. Significant
differences between active and sham acupuncture groups are indicated by *(P<.05), (P<.01), and (P<0.1).
Per-Protocol
Adj R2 (%)
Treatment Effect*
95% CI
Adj R2 (%)
Treatment Effect*
95% CI
36.9
33.7
49.5
0.11
1.27
0.27
3.4 to 3.6
7.5 to 4.9
3.5 to 3.0
.95
.68
.87
43.2
26.0
77.3
0.72
7.36
1.53
3.2 to 4.6
13.2 to 1.6
1.4 to 4.5
.70
.02
.28
*The stated treatment effect is the least-squares mean of the active treatment group minus the least-squares mean of the sham treatment
group.
The stated P values are not corrected for the number of outcome measures analyzed.
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48.
49.
50.
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