A Clinical Study On Treating Post Stroke Upper Limb Spasticity With Tong’s Extra Points

BackgroundStroke, is a general term which includes all kinds of acute cerebrovascular diseases and is a serious threat to human health. With the change of human lifestyle and dietetic habits, stroke is gradually recognized as having characteristics of high morbidity, mortality, disability and recurrence, low cure rate, more complications, and causes great economic losses for individuals, their families and the society. Epidemiological studies showed that the death toll of stroke becomes the highest among those of other causes in China, there are 1.5～2 million new stroke cases every year. According to the epidemiological investigation, the age-adjusted annual morbidity was 116～219 per 10 million population and the age-adjusted annual mortality was 58-142 per 10 million population. Currently, there are more than 7 million stroke patients in our country, and about 70% of survivors remain varying degrees of disability-hemiplegia was highest in sequelae. About 90% of stroke hemiplegic patients have spasticity. Upper limb spasticity is common in sequelae, the functional disorder caused influences the quality of life, which has become an important health aspect that should be tackled urgently. Therefore, in addition to conventional treatments (i.e. western medicine and therapy) for post stroke upper limb spasticity, we should explore the possibility of using TCM treatments, to enhance the effectiveness of rehabilitation therapy and to reduce the level of disability of hemiplegic patients. With the development of medical science, the use of acupuncture in treating sequelae of stroke becomes popular and has been proven to be effective and safe. However, stroke patients are usually accompanied by hypertension, diabetes, hyperlipidemia and so on, making the health situation complicated. Hence, acupoint selections and manipulations in regard to the specific situation are an important scope for research. Research results have indicated that treating sequelae of stroke with Tong’s Extra Points (TEP) was significantly better than that with traditional acupuncture. However, there was no relevant study report on treating post stroke upper limb spasticity with TEP. Such treatment method was therefore worthy of study in this clinical oberservation.TEP, which is also called Tong’s acupuncture, originated from Master Tong Qichang’s family. In recent years, the use of TEP becomes popular in many countries, such as China, America, South Korea, etc. TEP has unique acupoint selections, manipulations, diagnosis and theory, and it has been widely used in internal medicine, surgery, gynecology, pediatrics and ENT, and its effectiveness is obvious in clinical cases. Most stroke patients have clinic symptoms of deficiency-excess mixing, i.e. deficiency in the origin but with excess in symptom, including deficiency in liver and kidney, lack of Qi and blood, dystrophy in brain, stagnation of phlegm and blood, chaos of Qi and blood. In this study, we used Shenguan point as main treatment point which could nourish spleen and kidney, choosed Linggu point and Dabai point which could tonify Qi and warm Yang, Zusanzhong point and Muhuo point which could invigorate the circulation of Qi and blood, along with Quling point, Zhongzi point and Zhongxian point which were good at reducing spasticity, as assisted points. The use of these points achieved a good clinical effect.In brief, the results of this research study have provided evidence for further popularization of TEP. In the study, TEP’s treatment effects on post stroke upper limb spasticity were observered and compared with conventional rehabilitation treatments. The clinical effects of treatments on 135 patients were evaluated objectively with Modified Ashworth Scale (MAS), China Stroke Scale (CSS), Fugl-Meyer Assessment Scores (FMA) and Modified Barthel Index (MBI).ObjectiveTo observe the clinical effectiveness and safeness of TEP for treating post stroke upper limb spasticity, for future reference of clinicians.Methods1. Source of cases and dividing groupsAll 135 post stroke upper limb spasticity patients were selected in the out-patient department of acupuncture and moxibustion and the in-patient department of neurology and rehabilitation from November 2013 to December 2014. The patients were randomly divided into the rehabilitation training group, the TEP treatment group and the combined treatment group, with 45 cases in each group.2. Diagnostic criteriaIn the study, the diagnostic criteria of TCM followed the Diagnosis of Stroke and the Evaluation of Curative Effect (Trial) in 1996. The diagnostic criteria of western medicine followed the Diagnostic Gist of Cerebrovascular Diseases which was made at the fourth national cerebrovascular diseases conference in 1996.3. Inclusion criteria(1)Patients who met the diagnostic criteria above, aged from 35 to 80, male or female; (2) With clear consciousness, stable vital signs, along with treatment and willing to take the treatment persistently; (3)Onset time more than 2 weeks; (4)With post stroke upper limb spasticity, Brunnstrom stage maintain at II-III, upper limbs was level II or above level II according to Modified Ashworth Scale (MAS); (5) Signed the informed consent; (6)Diagnosed by CT or MRI.4. Exclusion criteria(1)Patients who met the diagnostic criteria above but without upper limb spasticity; Older than 80, or younger than 35; (3)In a critical condition or an unstable acute situation; (4)accompanying severe diabetes or diseases of heart, lungs, liver and kidneys or osteoporosis or severe bleeding tendency; (5)Systolic blood pressure> 180 mmHg and/or diastolic blood pressure> 110 mmHg; (6)Afraid of unrelated medicine which might influence this study.5. Elimination, suspension and drop-out criteria(1) Patients who were not in the inclusion criteria, or with low degree of compliance with instructions; (2) had severe adverse reactions; (3) health conditions worsen and with severe complications in the course of this study.The results for patients who undergone 1/2 of the treatment course would be included in the effectiveness evaluation. The results for patients who terminated the experiments because of adverse conditions would be regarded as adverse reaction cases.6. Therapeutic Method(1)Basic treatmentAll patients should receive basic treatment, including controlling blood pressure and blood glucose, adjusting blood lipid, anti-platelet aggregation, nourishing the nerve, giving necessary nutritional support and other symptomatic treatment, to prevent and cure the complications.(2)TEP treatmentAcupoints selection:we used Shenguan on both sides to nourish spleen and kidney. And choosed healthy side’Linggu and Dabai to tonify Qi and warm Yang, Zusanzhong to invigorate the circulation of Qi and blood, Muhuo to cure apoplexy sequel. Along with Zhongzi, Zhongxian, Quling on the spasticity side to reduce spasticity.Operation:acupuncture at Muhuo on healthy side firstly, with the depth of 0.5-1 cun and the time of less than 10 minutes, at the same time, advised patients to exercise the limb by himself or passively with the help of the doctor. Pull out the needle at Muhuo, acupuncture at Shenguan towards the direction of kidney meridian and liver meridian for 1-2 cun, select the healthy side first then the spasticity side. Triply puncture 0.5-1 cun from Dabai to Linggu on the healthy side. Triply puncture 1.5-2 cun from Linggu to Zhongxian on the same side. Triply puncture 1.5-2 cun at Zusanzhong close to fibula. Acupuncture at Zhongzi and Zhongxian 0.5-1 cun straight. After giving strong manipulation, acupuncture at Quling 1-1.5 cun then use reducing method of twirling. Retain needles after arrival of qi, and manipulate needles for every 5minutes.(3)Orally-taken western medicine treatmentAntispasmodic drugs Baclofen was taken 10mg each time,3 times per day. The dose of Baclofen was added according to patients’ conditions, and the maximum dosage of Baclofen should not exceed 75mg/day.(4)Rehabilitation training treatmentGood limb position:upper limb of the spasticity side was kept extended, external rotation, elbow extension, forearm supination, wrist and finger extension, thumb extended. Bobath handshake training:arms were pulled over head upright for 10 times,6 trainings a day. Rehabilitation training:spasmodic muscle was pulled continuously, joint mobilization techniques were used in necessity, and separation movement was induced immediately as soon as spasmodic muscle became relaxed. The training continues for total 45 minutes.All patients in the three groups received basic treatments. Patients in group A received oral Baclofen treatment and rehabilitation training treatments, while group B received TEP treatments and group C received both TEP and rehabilitation training treatments.7. Observing Methods(1)Period of obervation:TEP and rehabilitation training treatments should be operated once daily with 5 times per week and then they should rest for 2 days. All treatments lasted for 6 weeks.(2)Main evaluation index:①Clinical curative effectCure:Muscular tension was returned to normal.Remarkable effect:Muscular tension was reduced 2 levels or more than 2 levels.Effective:Muscular tension was reduced 1 level.Invalid:Muscular tension wasn’t reduced or increased.②Assessment of muscle tensionMAS was taken as an appraisal tool to evaluate the level of improvement of muscular tension. During the evaluation the operator stretched the spastic muscle to exercise patients’ affected upperarm within the range of motion. The patients’ spasm was divided into five levels, and the operator classified the level against the resistance felt during the arm movement.③Assessment of motor function of affected upperarmFMA was taken as an appraisal tool to evaluate the degree of improvement of motor function. Evaluation contents included tendon reflex, flexor exercise together, extensor exercise together, action with co-movement and so on. FMA included 33 items, and every item was divided into three ranks. Total score was 66 points.(3)econdary evaluation index① Assessment of neurological deficencyCSS was taken as an appraisal tool to evaluate the degree of improvement of neurological impairment. Evaluation contents included consciousness, horizontal gaze, facial nervous function, speak, motor function and viability. The higher the score obtained, the more was the severe neurologic deficiency. The highest score was 45, the lowest score was 0.②Assessment of activities of daily livingMBI was taken as an appraisal tool to evaluate the degree of improvement of ADL. Evaluation contents included controlling stool and urination, eating, putting on clothes, defecation, washing oneself and so on. MBI included 10 items, and every item could be divided into five ranks. Different levels represented different degrees of independent ability, and there was positive correlation between them. The highest rank was Rank 5, and the lowest rank was Rank 1. The maximum mark was 100.(4)Observation of adverse reactionThe adverse reaction was recorded in the treatment process.8. Data ProcessingThe data was analyzed by using the SPSS 20.0 for Windows software package with the help of special staff. Comparision of baseline and side effects was based on intent-to-treat population (ITTP), while comparision of the main and secondary indexes was based on modified intent-to-treat population (MITTP). Sampling data was shown in χ±SD, and variation data were shown in χ±SE, The normal distribution sampling data of pre-treatment and post-treatment was analyzed by paired "t" test, data comparisons of pre-treatments among groups were analyzed by one-way variance analysis, and data comparisons of post-treatments among groups were analyzed by covariance analysis. Enumeration data was analyzed by using "Chi-square" test. Sampling data, that were not normally distributed, were analyzed with Wilcoxon test within group and "Kruskal-Wallis H" test among groups. Level data were analyzed by Wilcoxon tests within group and ordered logit regression analysis among groups. The differences would be considered significant if P≤0.05.Results1. The drop-out cases and comparison of baselineThree of the 135 cases were terminated due to the request of the patient’s family, severe pain sensation and dizziness when needling. These 3 cases were excluded from the sampling data analysis and 132 cases were included for further analysis in this research. The gender, age, course of disease, character of disease, position of disease of patients, Ashworth score, CSS score, FMA score, and MBI score in the 3 groups in the pre-treatments were not significant(P>0.05), therefore the three groups of patients could be considered as comparable.2. Main evaluation index(1)Clinical curative effectThe reduced levels of muscle tension before and after treatment were used to evaluate the curative effectiveness among the three groups. The effective rates of the rehabilitation training group, TEP treatment group and the combined treatment group were respectively 64.44%,75.00% and 88.37%. The comparisons of the 3 groups was significant (χ2=6.434, P=0.040). The curative effectiveness of the combined treatment group was significantly better than that of the rehabilitation training group (P=0.034).(2)Improvement of muscular tensionMAS was taken as an appraisal tool to evaluate the level of improvement of muscular tension. The muscular tension of post-treatment in each group was significantly reduced comparing with pre-treatment (P<0.001). The curative effectiveness of the combined treatment group was better than that of the rehabilitation training group (P=0.36), while the curative effectiveness of the TEP treatment group between the other two groups with unsignificant difference.(3)mprovement of motor function of affected upperarmFMA was taken as an appraisal tool to evaluate the improvement degree of motor function. The FMA score of post-treatment in each group was significantly increased comparing with pre-treatment (P<0.001), this showed that the three treatment methods could promote recovery of motor function. The effect of the combined treatment group was better than that of the rehabilitation training group (P=0.010). The effect of the TEP treatment group lied between the two and the difference was not significant.3. Secondary evaluation index(1)Improvement of neurological deficencyCSS was taken as an appraisal tool to evaluate the degree of improvement of neurological impairment. The CSS score of post-treatment in each group was significantly increased comparing with pre-treatment (P<0.001), this showed that the three treatment methods could promote recovery of neurological function. The effect of the combined treatment group and the TEP treatment group were better than that of the rehabilitation training group (P=0.002,0.011). There was no significant difference between the TEP treatment group and the combined treatment group.(2)Improvement of activities of daily livingMBI was taken as an appraisal tool to evaluate the degree of improvement of ADL. The MBI score of post-treatment in each group was significantly increased comparing with pre-treatment (P<0.001), this showed that the treatment methods could improve the patients’ movement ability in daily life. The effect of the combined treatment group and the TEP treatment group were better than that of the rehabilitation training group (P=0.018,0.014). However, there was no significant difference between the TEP and the combined treatment group.4. Side effectIn this study, there was 1 case in the TEP treatment group in which the patient felt severe dizziness during puncturing. One patient in the combined treatment group had intolerable pain sensation during needling. Two patents felt sleepy, lack of strength and 8 patients had dizziness and nausea after taking Baclofen in the rehabilitation training group.ConclusionResults of this study suggested that the clinical curative effectiveness of Tong’s Extra Points (TEP) in treating patients who had post stroke upper limb spasticity of was good, with small adverse effects. TEP treatment can be an alternative therapy worthy of promotion.