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Department of Anaesthesiology, Pain Clinic, Medical School of Hannover, Hannover, GermanyLudwig-Boltzmann-Institute for Acupuncture, Vienna, AustriaKaiserin-Elisabeth-Spital, Outpatient Clinic for Acupuncture, Vienna, Austria
Neurologic outpatient department of a medical school in Germany.
Twenty-five patients (14 women) suffering from chronic poststroke leg spasticity with pes equinovarus deformity (Modified Ashworth Scale [MAS] score, ≥1), aged 38 to 77 years (mean ± standard deviation, 58.5±10.4y), were enrolled in the study. The mean time from stroke to inclusion in the study was approximately 5 years (mean, 65.4±48.3mo; range, 7–180mo).
Participants were randomly assigned to placebo treatment (n=12) by using a specially designed placebo needling procedure, or verum treatment (n=13).
Main outcome measures
MAS score of the affected ankle, pain (visual analog scale), and walking speed.
There was no demonstrated beneficial clinical effects from verum acupuncture. After 4 weeks of treatment, mean MAS score was 3.3±0.9 in the placebo group versus 3.3±1.1 in the verum group. The neurophysiologic measure of H-reflex indicated a significant increase of spinal motoneuron excitability after verum acupuncture (H-response/M-response ratio: placebo, .39±.19; verum, .68±.41; P<.05).
This effect might be explained by afferent input of A delta and C fibers to the spinal motoneuron. The results from our study indicate that needle acupuncture may not be helpful to patients with chronic poststroke spasticity. However, there was neurophysiologic evidence for specific acupuncture effects on a spinal (segmental) level involving nociceptive reflex mechanisms.
ALTHOUGH ACUPUNCTURE HAS been used for more than 2000 years in China and Japan, traditional Chinese medicine (TCM) has just begun to gain influence in Western civilizations in the last decades. In Europe, 12% to 19% of the population report using acupuncture,
Although acupuncture has captured the public interest and has come to be widely practiced, there is an obvious lack of rigorous research in this field: acupuncture literature is dominated by articles from China that are positive but often of poor scientific quality.
performed a randomized study on 78 patients with severe hemiparesis within 10 days of stroke onset. Forty patients in the control group received daily physiotherapy, and 38 received acupuncture, in addition, twice weekly for 10 weeks. Patients given acupuncture recovered both faster and to a greater extent than did the control group and had significant differences in improvement of balance, mobility, activities of daily living (ADLs), quality of life (QOL), and lengths of stay in hospital.
That study has been substantially criticized because the control group did not receive any placebo treatment. Another randomized controlled study, involving 45 patients, was performed in the subacute stage of stroke.
examined hemiparetic patients 40 days (median) after stroke. All participants had individually adapted rehabilitation therapy, and the 24 who were randomized to acupuncture received 20 to 30 minutes of classical acupuncture treatments 3 to 4 times a week for 6 weeks. Although both groups improved significantly in motor function and ADLs, the improvement was significantly greater among the acupuncture group.
acupuncture and transcutaneous nerve stimulation were applied in stroke rehabilitation, starting 5 to 10 days after stroke, totalling 20 treatments during a 10-week period. Johannsson could not find any beneficial effects on functional outcome or life satisfaction.
So far, no controlled randomized studies are available that concentrate on the effects of acupuncture in the chronic stage of poststroke spasticity; in particular, there are no studies including neurophysiologic techniques. Our study was devoted to examining the efficacy and safety of needle acupuncture in chronic poststroke leg spasticity.
Twenty-five patients (14 women), aged 38 to 77 years (mean ± standard deviation [SD], 58.5±10.4y), were enrolled in a single-blind study and randomly assigned to placebo (n=12) or verum treatment (n=13). The mean time from ischemic stroke to inclusion in the study was approximately 5 years (mean, 65.4±48.3mo). Time from stroke onset was at least 7 months (range, 7–180mo). All patients had hemiparesis and spastic equinovarus deformity of the affected leg. Causes for the recent stroke were identified as (1) cerebral thrombosis, mostly of the middle cerebral artery (14 cases); (2) brain hemorrhage (8 cases); and (3) other causes (3 cases). Both groups did not differ with respect to age, sex, severity of spasticity, and time from stroke at baseline (table 1). Patients were informed about the purpose of the research study and gave written informed consent to the experimental procedure. The study was approved by a local ethics committee. Main exclusion criteria were anticoagulation, pregnancy, history of epileptic seizures, acute or chronic infectious diseases, and autoimmune diseases (eg, multiple sclerosis, collagenosis). Concomitant medication (eg, baclofen) was allowed during the study and was documented carefully, but patients were required to keep the dose stable throughout the whole study. Threshold Modified Ashworth Scale (MAS) score required for admittance to this study was 1 or more.
Table 1Demographic Data of Placebo and Verum Group (at study entry)
After randomization, the patients underwent 2 treatments a week for a total of 8 treatments. The initial treatment was performed by a well-experienced acupuncture teacher (MB) from the Ludwig-Boltzmann-Institute for Acupuncture, Vienna, Austria. Further treatments were performed by well-trained acupuncturists (MF, MK) from the Medical School of Hannover, Germany. The acupuncture points used at study entry did not vary throughout the study (table 2). Most frequently, verum needles (Seirin B-type needle no. 8 [0.3×0.3mm] and no. 3 [0.2×0.15mm]) were inserted at acupoints GB34 (in the depression anterior and inferior to the head of the fibula), GB39 (3 cun above the tip of the external malleolus, in the depression between the posterior border of the fibula and the tendons of the peroneus longus and brevis muscles), LR3 (first interosseus muscle of the lower limb), and LI4 (first dorsal interosseus muscle of the upper limb) of the affected limbs, and, depending on additional symptoms, according to TCM criteria, at ST36 (lateral to the tibia at the level of the tuberositas tibiae) and LI10 (2 cun below the lateral end of the elbow fold) of the affected limbs, and at SP6 (3 cun directly above the tip of the medial malleolus, on the posterior border of the medial aspect of the tibia) and LU9 (at the radial end of the transverse crease of the wrist, in the depression on the lateral side of the radial artery), bilaterally. In addition, GV20 was needled in 10 of 13 patients. The needles (maximum of 15 needles per patient and treatment) were left in place for 30 minutes after insertion without further manipulation. The exact localization of the acupoints used in our study is described in table 3.
To avoid transdermal stimulation, placebo needles were inserted at defined nonacupoints (middle of the ventral surface of the affected thigh, middle of the medial side of the affected lower leg, middle of the affected foot, and middle of the back of both hands). The tip of the needle is blunt, and when it touches the skin patients feel a pricking sensation, simulating puncturing of the skin.
To place the needle, we used a cube-shaped elastic foam fixed on the skin. Therefore, it is not visible that the blunt placebo needle is not inserted into deeper tissue layers, but the blunt tip on the skin may be felt by the volunteers. Further, the needle appears to be shortened because of the elasticity of the foam. The investigator (who performed outcome measures), as well as the patients, was blind to treatment condition (placebo vs verum). Blinding the acupuncture practitioner was impossible, for methodologic reasons. None of the patients was able to distinguish between verum and placebo acupuncture. This was controlled by a questionnaire (credibility of treatment), used in earlier studies by our group.
The patients were carefully examined at baseline (assessment 0); reexamined immediately after the first acupuncture treatment (assessment 1); again immediately after the last treatment (4wk after first acupuncture; assessment 2); and finally, some of the efficacy variables were recorded about 3 months after completion of the study (assessment 3). Patients were examined neurologically (cranial nerves, motor and sensory system). The date of the current stroke, stroke etiology, leg affected, and number of falls the patient had experienced during the previous 4 weeks were recorded.
In addition, a 2-minute walk test (2MWT) was performed.
Patients were asked to walk continuously for 2 minutes, using their regular aids or orthoses, but with no support from the investigator. The walk took place over a distance of 10m, and patients were required to change direction of their own accord. The distance walked in a 2-minute interval was recorded. If the patient was not able to walk for 2 minutes, the distance and time walked was recorded.
A Rivermead Motor Assessment (RMA) test (leg and trunk section) was performed to evaluate motor function.
Step length was defined as the distance between initial foot strike of 1 lower limb and the initial foot strike of the opposite limb. Cadence was defined as the number of steps per minute. The mode of initial foot contact of the affected side was classified as follows: fore-foot versus sole versus heel.
A goniometry for the affected ankle was performed (based on the neutral-0 method), with the knee flexed and straight, and angles of active and passive movement were recorded.
Spasticity present at the ankle (spastic pes equinovarus) was rated clinically using the MAS. This scale allows a rating from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension).
A 2MWT, step length, and cadence was measured to obtain gait measures. Pain intensity (visual analog scale [VAS]: range, 0– 10cm; 0, no pain; 10, strongest pain) and pain localization (pain due to spasticity) were documented. Furthermore, patients and investigator were required to give a rating of their impression of improvement on a Clinical Global Impressions (CGI) scale
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The Hoffmann reflex, or H-reflex, is the neurophysiologic correlate of the Achilles’ tendon reflex. Electric stimuli of increasing intensities are applied to the tibial nerve in the hollow of the knee with conventional surface electrodes (starting with 10mA stimulus intensity, increasing in steps of 1–2mA until the H response disappears; duration of the electric stimulus, 0.3ms). Compound muscle action potentials (CMAPs) were recorded from the ipsilateral soleus muscle by using conventional surface electromyographic electrodes (different electrode in between the lateral and medial head of the gastrocnemius muscle, indifferent electrode on the Achilles’ tendon). The H response appeared approximately 30ms after submaximal stimulation. With increasing intensities, the M response was evoked (CMAP evoked by orthograde nerve stimulation) and the H response decreased (fig 1). The relation between maximal H response and M response is called Hmax/Mmax ratio and reflects the excitability of the spinal alpha motoneuron. The higher the state of excitability (and the more severe the leg spasticity), the higher the Hmax/Mmax ratio.
Statistical analyses used Mann-Whitney U tests. Outcome parameters (MAS, VAS, CGI, 2MWT, RMA, RMI, step length, cadence, goniometry, QOL measures, depression scale) were used as dependent variables, and treatment condition (placebo vs verum) was used as independent variable. Differences were regarded as significant at P less than .05. Results are reported as means and SDs. Further, bivariate Pearson correlations were done to correlate neurophysiologic measures with MAS score.
MAS scores (as a clinical measure of spasticity) did not show significant differences between placebo and verum in any of the follow-up examinations. The MAS scores at baseline were 3.1±0.8 in the placebo group and 3.0±1.2 in the verum group. At the first follow-up (immediately after the first treatment), the MAS score remained unchanged (placebo: 3.3±0.8; verum: 2.9±1.3). After the last treatment (4-wk follow-up), there was no significant difference between placebo and verum groups, either (placebo: 3.3±0.9; verum: 3.3±1.1).
The CGI patient rating indicated significantly worse results at assessment 2: although placebo-treated patients gave a mean rating of 1.1±1.2 points (equal to a “slight improvement”), verum-treated subjects reported only a mean of 0.3±0.6 points (equal to “no change”; z=−1.98, P<.05; fig 2).
From analyzing the neurophysiologic data, we found that the Hmax/Mmax ratio of the spastic leg indicated significant differences between both groups in assessment 2 (fig 3), but no significant differences at baseline or assessment 1. Baseline assessment (assessment 0) was .59±.28 for placebo-treated patients versus .75±.52 for verum-treated patients. Assessment 1 was .68±.37 for placebo group versus .87±.61 for verum group. Assessment 2 was .39±.19 for placebo subjects versus .68±.41 for verum subjects (z=−2.11, P<.05). The Hmax/Mmax ratio of the unaffected leg did not show any significant differences between the 2 groups. Bivariate Pearson correlations did not reveal any significant correlation between Ashworth score and Hmax/Mmax ratio at baseline or at assessment 2.
None of the other efficacy variables indicated significant differences between placebo and verum conditions at any of the follow-ups.
Needle acupuncture may be beneficial in the rehabilitation of poststroke patients in an acute or subacute phase.
Although many patients and acupuncturists believe in the beneficial effects of needle acupuncture in chronic poststroke leg spasticity, there are no controlled trials. This lack of data inspired us to perform a study focusing on the effects of acupuncture in the chronic state after stroke. From a methodologic point of view, it was essential to use a placebo method of needling with the same psychologic impact as verum needling. Streitberger and Kleinhenz,
have developed and introduced a placebo needle in which a mounted blunt needle strikes the skin without penetrating it. This placebo needle permits a valid control of the placebo effect in acupuncture studies.
As a major result, we did not find any beneficial, spasticity-reducing effect from verum acupuncture. Indeed, verum-treated patients reported significantly worse CGI after the end of treatment (assessment 2).
An explanation for these poor clinical results may be derived from the neurophysiologic data. Hmax/Mmax ratio as an objective measure of the severity of spasticity
and indicates that verum acupuncture induced a facilitation of the lower motoneuron, probably on a spinal (segmental) level. How can this facilitation be explained? Among other mechanisms, segmental analgesic effects of needle acupuncture are based on a stimulation of A delta or group III small myelinated primary afferents and C fibers.
have examined synaptic actions of cutaneous A delta and C fibers of primate hindlimb alpha motoneurons (as a model of the so-called withdrawal or nociceptive reflex). They found that A delta volleys caused motoneurons to fire in several instances, and some motoneurons discharged repetitively during the depolarizations evoked by activities in C fibers.
studied the responses of these efferents to stimulation of A beta, A delta, and C fiber cutaneous afferents in the sural nerve. Short latency reflexes were elicited in all efferents by A beta inputs, longer latency reflexes were elicited in 64% by A delta inputs, and very-long latency responses with long afterdischarges were found in 73% of the units to C inputs.
Thus, a higher Hmax/Mmax ratio (indicating a higher excitability of spinal motoneurons) might be explained on a segmental level by nociceptive reflex mechanisms involving A delta and C fiber input. Because motoneuron excitability was elevated in verum- (vs placebo-) treated patients, one might conclude that this finding delivers evidence of a specific needle acupuncture effect (modulated by nociceptive reflex mechanisms). This neurophysiologic effect might also account for the worsening of clinical symptoms (CGI), which could be observed in the verum-treated group.
Another explanation for the negative results of our study could be the technique of needle acupuncture. It should be noted that acupuncture per se is not one entity and that there are several other acupuncture techniques—for example, electro-acupunture
However, the results from our study suggest that needle acupuncture in the chronic state after stroke may not reduce spasticity. Although clinical effects were rather discouraging, neurophysiologic examinations revealed specific segmental acupuncture effects mediated through nociceptive reflex mechanisms. Because we have very little scientific evidence for specific modes of action, further studies focusing on these neurophysiologic effects of needle acupuncture are strongly encouraged.