Prospective,Randomized Controlled Trial of Physiotherapy and Acupuncture on Motor Function and Daily Activities in Patients with Ischemic Stroke

Abstract

Objective:

To assess the value of acupuncture for promoting the recovery of patients with ischemic stroke and to determine whether the outcomes of combined physiotherapy and acupuncture are superior to those with physiotherapy alone.

Design:

Prospective randomized controlled trial.

Setting:

Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, P. R. China.

Participants:

120 inpatients and outpatients (84 men and 36 women).

Interventions:

Acupuncture, physiotherapy, and physiotherapy combined with acupuncture.

Main outcome measures:

Motor function in the limbs was measured with the Fugl–Meyer assessment (FMA). The modified Barthel index (MBI) was used to rate activities of daily living. All evaluations were performed by assessors blinded to treatment group.

Results:

On the first day of therapy (day 0, baseline), FMA and MBI scores did not significantly differ among the treatment groups. Compared with baseline, on the 28th day of therapy the mean FMA scores of the physiotherapy, acupuncture, and combined treatment groups had increased by 65.6%, 57.7%, and 67.2%, respectively; on the 56th day, FMA scores had increased by 88.1%, 64.5%, and 88.6%, respectively (p<0.05). The respective MBI scores in the three groups increased by 85.2%, 60.4%, and 63.4% at day 28 and by 108.0%, 71.2%, and 86.2% at day 56, respectively (p<0.05). However, FMA scores did not significantly differ among the three treatment groups on the 28th day. By the 56th day, the FMA and MBI scores of the physiotherapy group were 46.1% and 33.2% greater, respectively, than those in the acupuncture group p<0.05). No significant differences were seen between the combined treatment group and the other groups. In addition, the FMA subscores for the upper extremities did not reflect any significant improvement in any group on the 56th day. Although the FMA subscores for the upper and lower extremities and the MBI score in the combined treatment group were higher than those in the acupuncture group, the differences were not statistically significant.

Conclusions:

Acupuncture is less effective for the outcome measures studied than is physiotherapy. Moreover, the therapeutic effect of combining acupuncture with physiotherapy was not superior to that of physiotherapy alone. A larger-scale clinical trial is necessary to confirm these findings.

Introduction

S troke is a main cause of adult disabilities.¹ Poststroke hemiplegia, especially motor dysfunction, severely affects patients' daily activities, causing a heavy burden on family and society.² In China, both physiotherapy and acupuncture are used widely in stroke rehabilitation, and physiotherapy is recognized worldwide as an effective treatment.³ A previous study has also demonstrated that community-based rehabilitation is effective for stroke patients in China.⁴

Acupuncture is an essential part of Traditional Chinese Medicine, and it is proven to exert an analgesic effect^5,6 and promote stroke recovery.⁷ Studies have demonstrated the enhancement of motor function and limb balance resulting from acupuncture therapy.^8,9 Moreover, acupuncture helps protect against brain damage in monkeys and rats^10,11 through the activation of cannabinoid receptor type 1 and adenosine A1 receptor.^12,13

However, whether acupuncture promotes recovery from ischemic stroke remains controversial; a systematic review of five trials showed that methodologic quality of the included trials was inadequate and the results may not be reliable because of substantial heterogeneity.¹⁴ In addition, it is unknown whether the outcomes of combined physiotherapy and acupuncture are superior to those of physiotherapy alone; very few studies have compared the two therapies. Therefore, the present prospective, randomized controlled clinical trial compared combined physiotherapy and acupuncture with physiotherapy alone and acupuncture alone in the recovery of ischemic stroke to establish the optimal treatment for stroke rehabilitation.

Material and Methods

Patients

One hundred and twenty inpatients and outpatients (84 men and 36 women; mean age±standard deviation, 61.54±9.47 years; mean time poststroke, 39.93±20.94 days; 56 patients presenting with stroke on the right hemisphere and 64 on the left) were recruited from the Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, P.R. China, from May 26, 2008, to November 30, 2009. Inclusion criteria were (1) Chinese patients with first-time ischemic stroke confirmed by computed tomography or magnetic resonance imaging, (2) consciousness after stroke, (3) stable vital signs, (4) admission 15–90 days after stroke onset, (5) a neurologic deficiency score ≥10 points for limb impairment, and (6) age 40–75 years. Exclusion criteria were (1) unstable vital signs or decompensation of function of important organs, (2) patients with quadriplegia, (3) patients with preexisting cerebrovascular disease and left-limb motor dysfunctions, and (4) patients who could not be followed up.

Design and setting

This study was carried out in the Department of Rehabilitation Medicine, Huashan Hospital, Fudan University. The Ethics Committee of Huashan Hospital, Fudan University, approved the study, and the trial was performed in accordance with the Declaration of Helsinki. Each patient signed an informed consent form before enrollment.

Intervention

Each patient was allocated by random number to the physiotherapy, acupuncture, or combined treatment group. In the randomization process, a research assistant opened envelopes containing random numbers and informed an acupuncturist or therapist if the patient was in the respective intervention group. The research assistant also informed physicians of the recruitment but not the group assignment. Additionally, she reminded the patients not to tell the physicians or the therapists whether they were treated with acupuncture. All patients received standard routine internal medicine care during the trial. All of the acupuncturists, physicians, and therapists were well qualified and experienced, and they had received specific training before the beginning of this trial.

Acupuncture therapy

The main acupoints were as follows: Baihui (GV20), Jianyu (LI15), Jianzhen (SI9), Quchi (LI11), Waiguan (TE5), Hegu (LI4), Yanglingquan (GB34), Kunlun (BL60), Juegu (GB39), Huantiao (GB30), Fengshi (GB31), Neiguan (PC6), Shangqiu (SP5), Taichong (LR3), Yinlingquan (SP9), Sanyinjiao (SP6), Yingu (KI10), Daling (PC7), Hegu (LI4), Houxi (SI3), Jiquan (HT1), Chize (LU5), and Quze (PC3). Selection of the acupoints was based on Traditional Chinese Medicine theory. The depth of acupuncture depended on the somatotype of the patient. After a needle sensation was obtained, the needle was kept in situ for 30 minutes. Each patient in this group received acupuncture 30 minutes per day, 6 consecutive days per week, for 4 weeks. Hwato sterile acupuncture needles (Acupuncture Suzhou, Suzhou, P.R. China) for single use were used.

Physiotherapy

According to the phase of hemiplegia, we adopted specific physiotherapies to improve patients' activities of daily living (ADLs).

Program for atonic stage (Brunnstrom stages 1–2)

The goals of this stage are to prevent contracture of joints and secondary damages, promote normal sensorimotor sensation, and encourage optional independent movement. Patients were required to complete the following exercises: (1) correct limb placement; (2) passive joint movement; (3) turning the body over, following a correct method; (4) transferring from a decubitus to a sitting position; (5) bend-the-crab; and (6) neuromuscular facilitation. Each patient in this group underwent the preceding exercises 45 minutes per day, 6 consecutive days per week, for 4 weeks.

Program for spasm stage (Brunnstrom stages 3–5)

The goals of this stage were to decrease muscle tension, prevent spasms in the limbs, and promote separate movement. Patients were required to complete the following exercises: (1) antispasm limb placement, (2) trunk muscle distraction, (3) sitting balance, (4) transferring from a sitting to a standing position, (5) standing balance, (6) walking, and (7) upper-limb control. Each patient in this group underwent the preceding exercises 45 minutes per day, 6 consecutive days per week, for 4 weeks.

Physiotherapy plus acupuncture therapy group

For the combined acupuncture and physiotherapy group, the acupoints were the same as for the group receiving acupuncture alone, and the physiotherapy was identical to that in the physiotherapy alone group. Each patient received 30 minutes of acupuncture and 45 minutes of physiotherapy per day. Treatments were performed 6 consecutive days per week and lasted for 4 weeks.

Evaluations and measurements

The simplified Fugl–Meyer assessment (FMA) and modified Barthel index (MBI) were used to evaluate limb motor function and ADLs at days 0 (M₀), 28 (M₁), and 56 (M₂).

Simplified FMA

The FMA scale is a 226-point multi-item scale containing five domains.^15,16 This stroke-specific, performance-based impairment index is designed to assess motor function, balance, sensation, and joint functions in patients who have had a hemiplegic stroke. This study used only the motor domain of the FMA scale to evaluate the motor function of patients' limbs. This scale included measurements for movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, hand, hip, knee, and ankle. All these measurements were scored on a three-point ordinal scale (0=cannot perform, 1=performs partially, 2=performs fully). The score ranged from 0 (hemiplegia) to 100 (normal) points and was divided into 66 points for the upper extremity and 34 points for the lower. A score of ≤50 points indicated severe movement disorder, 50–84 indicated significant movement disorder; 85–95 indicated moderate movement disorder, and 96–99 indicated mild movement disorder.

MBI

The MBI is widely used to measure performance in ADLs.^17,18 It contains 10 items describing ADLs and mobility. Each item is scored as 0, 5, or 10 points for cannot perform, performs partially, or performs fully, respectively. Possible scores range from 0 to 100 points. Patients with ≥61 points are considered independent, a score of 41–60 means that the patient requires some help, 21–40 indicates that the patient requires a moderate amount of help in daily living, and ≤20 indicates that the patient requires labor service. The 10 items addressed in the MBI are (1) fecal incontinence, (2) urinary incontinence, (3) grooming ability, (4) toilet use, (5) feeding, (6) transfers (e.g., from chair to bed), (7) walking, (8) dressing, (9) climbing stairs, and (10) bathing. Therapists who performed outcome assessments did not provide daily care to any particular patient and were blinded to the group division.

Statistical analysis

The t-test, analysis of variance, and χ² test were used to evaluate demographic characteristics and other variables for the three groups. Measurement data were analyzed with the t-test, and the numeration data were analyzed with a χ² test. The variance among the three groups was evaluated using analysis of variance. Analyses were performed with SPSS software for Windows, version 16.0 (SPSS Inc., Chicago, Illinois). Data are expressed as mean±standard deviation. The level of significance was set at 5% for all comparisons.

Results

General information

A total of 120 Chinese patients were enrolled in this trial; 41 patients were randomly assigned to the physiotherapy group, 39 to the acupuncture group, and 40 to the combined therapy group. Demographic characteristics (Table 1) were similar among the three groups, and gender, age, injured area, affected side, time from stroke onset, and comorbid conditions did not significantly differ among groups.

Table 1.

Characteristics of Study Patients

Characteristic	Physiotherapy group (n=41)	Acupuncture group (n=39)	Combined group (n=40)
Gender (n)
Male	30	29	25
Female	11	10	15
Mean age±SD (y)	59.30±9.66	63.69±8.70	61.65±11.05
Injured area (n)
Basal ganglia	16	12	18
Other	25	27	22
Side affected (n)
Left	23	18	19
Right	18	21	21
Time from stroke onset (d)	40.54±21.44	37.13±21.34	42.12±20.06
Comorbidity (n)
Hypertension	22	23	24
Diabetes mellitus	8	5	5
Hyperlipemia	6	2	4
Myocardial infarction	6	7	8

Increase in FMA and MBI scores in all treatment groups

To examine whether acupuncture alone or combined with physiotherapy improved limb motor function and ADLs in patients with ischemic stroke, the FMA and MBI scores of each group were evaluated (Table 2). FMA and MBI scores did not significantly differ among the three groups on day 0 (M₀) (p=0.435 and p=0.523, respectively). However, on day 28 (M₁), the FMA scores for the physiotherapy, acupuncture, and combined therapy groups had significantly increased by 65.6%, 57.7%, and 67.2%, respectively, when compared with the FMA values at M₀. At day 56 (M₂), the respective FMA scores had increased by 88.1%, 64.5%, and 88.6% (p=0.009 for FMA_M1 and p=0.017 for FMA_M2), respectively.

Table 2.

Fugl–Meyer Assessment and Modified Barthel Index Scores in Study Patients

	FMA score			MBI score
Group	M₀	M₁	M₂	M₀	M₁	M₂
Physiotherapy	22.11±13.70	36.61±15.80^*	41.58±18.04^*	32.39±15.05	60.00±20.09^*	67.36±20.28^*
Acupuncture	21.68±13.20	34.19±18.10^**	35.67±19.14^**	36.13±17.26	57.96±22.67^**	61.85±22.16^**
Combined	18.65±11.97	31.18±17.38^***	35.18±18.12^***	35.15±13.68	57.42±21.66^***	65.45±21.01^***

Values are expressed as the mean±standard deviation.

p<0.05 compared with M₀ in physiotherapy group (t-test).

p<0.05 compared with M₀ in acupuncture group (t-test).

***

p<0.05 compared with M₀ in combined group (t-test).

FMA, Fugl–Meyer assessment; M₀, day 0; M₁, day 28; M₂, day 56; MBI, modified Barthel index.

Similarly, on day 28 the MBI scores of the physiotherapy, acupuncture, and combined therapy groups were increased by 85.2%, 60.4%, and 63.4%, respectively, compared with those on day 0. On day 56, MBI values were increased by 108.0%, 71.2%, and 86.2%, respectively (p=0.023 for MBI_M1 and p=0.014 for MBI_M2). However, FMA and MBI did not significantly differ among the three treatment groups at day 28 or day 56 (p=0.089 for FMA_M1, p=0.114 for FMA_M2, p=0.223 for MBI_M1, p=0.147 for MBI_M2).

Significant improvement of FMA and MBI scores at day 56

The purpose of this study was to determine whether physiotherapy plus acupuncture was superior to physiotherapy alone or acupuncture alone. The improvement in FMA and MBI scores for the three groups at day 28 compared with day 0 (M_1–0) and day 56 compared with day 0 (M_2–0) is shown in Table 3. The differences in FMA and MBI scores were not statistically significant between days 0 and 28 among the groups (p=0.398 for FMA_M1–0, p=0.157 for MBI_M1–0). FMA scores in the physiotherapy group were increased by 14.06±9.93; however, differences were not statistically significant.

Table 3.

Fugl–Meyer Assessment and Modified Barthel Index Promotion Scores in Study Patients

	FMA score		MBI score
Group	M_1–0	M_2–0	M_1–0	M_2–0
Physiotherapy	14.06±9.93	19.03±1.36^*	27.19±15.12	34.56±16.76^*
Acupuncture	11.52±9.75	13.00±1.17	22.04±11.60	25.93±15.30
Combined	12.21±1.02	16.21±1.10	22.12±14.79	30.15±14.33

Values are expressed as the mean±standard deviation.

p<0.05 compared with acupuncture group (analysis of variance).

FMA, Fugl–Meyer assessment; M_1–0, day 28 versus day 0; M_2–0, day 56 versus day 0; MBI, modified Barthel index.

On the 56th day of therapy, the FMA and MBI scores in the physiotherapy group were greater by 46.1% and 33.2%, respectively, than those in the acupuncture group (p=0.018 for FMA_M2–0, p=0.005 for MBI_M2–0). The FMA and MBI scores in the combined therapy group were higher than those in the acupuncture group on days 28 and 56; however, the differences were not statistically significant for this comparison or between the combined therapy and physiotherapy groups.

Significant improvement in lower-extremity FMA on day 56 of physiotherapy

To assess possible differences in the upper- or lower-extremity response to the three treatments, and to determine which method was better at improving motor functions in these areas, FMA subscores on days 28 (M_1–0) and 56 (M_2–0) were evaluated. The results are summarized in Table 4. Although the improvements in FMA subscores for the upper and lower extremities were not statistically significant 28 days after treatment (p=0.483 for FMA_UP1–0, p=0.100 for FMA_LO1–0), improvements in the lower extremities were greatest in the physiotherapy group and the score in the combined group was higher than that in the acupuncture group. FMA scores for the upper extremities did not significantly differ among the three groups compared with the baseline FMA on day 0.

Table 4.

Differences in Upper- and Lower-Limb Fugl–Meyer Scores in Study Patients

	Upper-limb FMA		Lower-limb FMA
Group	M_1–0	M_2–0	M_1–0	M_2–0
Physiotherapy	8.32±8.10	11.06±9.27	7.16±4.78	8.61±5.14^*
Acupuncture	6.04±6.55	6.89±8.39	5.11±3.86	6.00±3.98
Combined	6.64±6.80	8.88±7.72	5.73±4.50	7.48±4.21

Values are expressed as the mean±standard deviation.

p<0.05 compared with acupuncture group (analysis of variance).

FMA, Fugl–Meyer assessment; M_1–0, day 28 versus day 0; M_2–0, day 56 versus day 0.

On the 56th day (M_2–0), the FMA subscore in the lower extremities was significantly greater in the physiotherapy group than in the acupuncture group (p=0.01 for FMA_LO2—0).

However, FMA scores did not significantly differ between the combined therapy and physiotherapy groups, either in the upper or the lower extremities (p=0.084 for FMA_LO2–0, p=0.078 for FMA_UP2–0).

Discussion

Acupuncture is popularly considered a viable alternative treatment for poststroke rehabilitation. According to a recent study in Canada, 87% of stroke patients were willing to receive acupuncture treatment and 98% were willing to learn more about acupuncture for stroke rehabilitation.¹⁹ However, the value of acupuncture for this purpose is still controversial.^20,21 Therefore, the current study was conducted to evaluate the therapeutic effects of acupuncture in poststroke rehabilitation.

In this study, the points were chosen according to Traditional Chinese Medicine syndrome differentiation of six channels: Tai Yang, Yang Ming, Shao Yang, Tai Yin, Shao Yin, and Jue Yin. The six-channel method was developed in the Eastern Han Dynasty by Zhong-Jing Zhang, a famous doctor. The three yin channels are located in the interior parts of the body, and the three yang channels are located in the exterior part of the body. Therefore, a Traditional Chinese Medicine practitioner could identify what phase of stroke a patient was in by the signs and symptoms displayed on one of the six meridians and thereby select the appropriate points. The more interior the stroke, the more severe the illness and damage to the organs. Furthermore, although syndromes of the six channels differed, they were interrelated through a continued changing process.

In the current study, FMA and MBI scores assessed at day 0 did not significantly differ between the physiotherapy and acupuncture groups. This finding demonstrates that the baseline levels were similar between the two groups. Both scores significantly increased in each group from day 0 to day 28, as well as from day 0 to day 56. However, the scores did not significantly differ between the physiotherapy and acupuncture groups on day 28 or 56. These results show that improvements in motor function and ADLs in the acupuncture group were similar to those in the physiotherapy group over time and therefore that acupuncture therapy was as effective as physiotherapy. Furthermore, although no significant differences in FMA and MBI scores were seen between the two groups after 28 days of treatment, at 56 days these scores were significantly greater for patients in the physiotherapy group. This finding suggests that the therapeutic effect of physiotherapy was better than that of acupuncture in the long term.

In this study, physiotherapy and acupuncture had a similar influence on motor functions of the upper limbs at days 28 and 56. However, the FMA and MBI scores for the lower limbs were higher in the physiotherapy group than the acupuncture group. This result demonstrates that the lower limbs responded better to physiotherapy than did the upper limbs. This result is consistent with those of a previous study showing that recovery of upper-limb function is one of the most difficult problems for stroke patients.²² Neither physiotherapy nor acupuncture elicited a satisfactory functional recovery of the upper limbs. Therefore, new therapeutic strategies to solve this problem should be investigated.

FMA and MBI scores did not significantly differ between the physiotherapy and the combined therapy groups at days 28 and 56. This finding suggests that acupuncture provides no additional value to physiotherapy in terms of poststroke motor function. This may be because acupuncture actually has no additional value for stroke patients who receive physiotherapy or because the sample size of this study was not large enough to show a difference between the groups.

Although these results indicate that both physiotherapy and acupuncture can be beneficial for patients with ischemic stroke, the study still has some limitations. First, the study included no blank therapy group because it would be unethical to withhold rehabilitation measures from enrolled patients. Second, some confounding factors might have compromised the results of the trial because sites of brain injury and motor dysfunctions could not be identical in each patient. Third, treatment time and follow-up time, as well as the number of patients enrolled, were relatively limited because of insufficient funding. The surprising results of this study indicate the need for further investigations with more patients and longer treatment and follow-up times.

This study confirms the therapeutic effect of physiotherapy in poststroke rehabilitation, a finding inconsistent with those of a previous study.⁴ The trial also showed the beneficial effect of acupuncture therapy, especially on lower-limb function; this result is the same as that reported by Liu et al.⁸ Very few studies have assessed physiotherapy plus acupuncture therapy; nevertheless, in the present trial acupuncture added no extra value to physiotherapy. Further investigation is necessary to confirm these results.

In conclusion, although acupuncture is less effective than physiotherapy in terms of outcome measures, it can promote the recovery of ischemic stroke by improving motor function and the ability to perform ADLs. However, the treatment effect of physiotherapy plus acupuncture was not superior to that of physiotherapy alone, and a larger-scale clinical trial is required to confirm this.

Footnotes

Acknowledgment

We sincerely appreciate the participation of the patients and their caregivers in this study. We gratefully acknowledge the support of Zhang Feng, Zhang Bei, Cui Xiao, Yu Xianmin, and He Qiang. The study was supported by the major research project of Zhabei District Health Bureau (no. 2008-05) and the scientific research project of Shanghai Municipal Health Bureau (no. 2009-250).

Disclosure Statement

No competing financial interests exist.

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