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Acupuncture treatment on the motor area of the scalp for motor dysfunction in patients with ischemic stroke: study protocol for a randomized controlled trial

Acupuncture treatment on the motor area of the scalp for motor dysfunction in patients with... Background: Scalp acupuncture has shown a remarkable treatment efficacy on motor dysfunction in patients with stroke in China, especially the motor area of Jiao’s scalp acupuncture, which is the most widely used treatment. However, previous studies have summarized that the clinical curative effect of acupuncture treatment for stroke remains uncertain. Meanwhile, no randomized controlled trials on Jiao’s scalp acupuncture have been performed. The aim of this study is to evaluate the efficacy and safety of Jiao’s scalp acupuncture for motor dysfunction in ischemic stroke. Methods/design: This is an assessor- and analyst-blinded, randomized controlled trial. One hundred and eight stroke patients with motor dysfunction meeting the inclusion criteria will be allocated by a 1:1 ratio into either an acupuncture treatment group or a control group. Stroke patients in the control group will receive conventional rehabilitation treatment, whereas a combination of Jiao’s scalp acupuncture and conventional rehabilitation treatment will be applied to the acupuncture group. Forty treatment sessions will be performed over an 8-week period. The Fugl-Meyer Assessment scale will be assessed as the primary outcome measure. The Modified Barthel Index, the Stroke-Specific Quality of Life, and the Stroke Syndrome of Traditional Chinese Medicine scales will be selected as secondary outcome measurements. All assessments will be conducted at baseline, week 4 (treatment 20), week 8 (treatment 40), week 12 (follow-up), and week 16 (follow-up). Discussion: This is the first trial evaluating the efficacy and safety of Jiao’s scalp acupuncture for motor dysfunction in ischemic stroke. The results of this trial are expected to provide relevant evidence demonstrating that Jiao’sscalp acupuncture can be used as an effective rehabilitation treatment method for improving motor dysfunction in ischemic stroke. Trial registration: ClinicalTrials.gov, NCT02871453. Registered on 17 July 2016. Keywords: Ischemic stroke, Motor dysfunction, Jiao’s scalp acupuncture, Study protocol * Correspondence: 13512183795@163.com; jianpei99@yahoo.com Department of Acupuncture, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, No. 725 South WanPing Road, XuHui District, Shanghai 200032, China Full list of author information is available at the end of the article © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Wang et al. Trials (2017) 18:287 Page 2 of 11 Background to treat motor dysfunction in stroke patients in hospi- The epidemic survey data from the Global Burden of tals. The motor area of Jiao’s scalp acupuncture or the Diseases, Injuries, and Risk Factors Study (GBD 2010) anterior oblique line of the vertex-tempora of the inter- ranked stroke as the second most common cause of national standardized scalp partition is usually selected death, the most common cause of disability [1], and the as the scalp acupuncture stimulatory region to treat third most common cause of disability-adjusted life years motor dysfunction in stroke patients; however, Jiao’s (DALYs) worldwide [2]. Over the past two decades, the scalp acupuncture is the more widely used of the two absolute number of people with first stroke (16.9 mil- techniques [18]. Jiao’s scalp acupuncture combines a lion), stroke survivors (33 million), and stroke-related modern understanding of neuroanatomy and neuro- deaths (5.9 million) and the overall global burden of physiology with traditional techniques of Chinese acu- stroke (DALYs lost, 102 million) have been on the rise puncture to develop a radical new tool for affecting the [3]. Statistics from the American Heart Association show functions of the central nervous system and accepts a that approximately 795,000 people experience a new or central theory that incorporates brain functions into recurrent stroke each year [4]. In China, stroke is re- Chinese medicine principles. The motor area of Jiao’s ported as one of the most common causes of death in scalp acupuncture that is specifically used for treatment both urban and rural areas [5, 6]. An epidemiologic of motor dysfunction after stroke is equivalent to the study published in 2007 indicates that China has more structure of the precentral gyrus of the cerebral cortex than 7 million stroke survivors. Ischemic stroke is the on the scalp projection [19]. However, no randomized most common subtype of stroke, accounting for about controlled trials (RCTs) have been performed to demon- 80% of all strokes. Approximately 70% of stroke survi- strate the clinical curative effect of the motor area of vors experience functional disabilities, motor dysfunc- Jiao’s scalp acupuncture treatment on motor dysfunction tion being the most significant symptom [7, 8]. The in patients with stroke. activities of daily living and social participation are lim- Moreover, with the rapid development of evidence- ited in patients with stroke due to motor dysfunction; based medicine, any clinical intervention strategies this greatly influences the patient’s quality of life and re- which are used must be backed by a high level of turn to society. Also, these limitations place a heavy bur- evidence-based support. Although acupuncture as a den on the family and society as a whole, becoming a treatment for stroke has become widely accepted and huge public health problem [9]. has shown a better clinical curative effect than con- Western conventional treatment of patients with ventional treatments, numerous meta-analysis reviews stroke includes pharmacological treatments, surgical op- [14, 20–25] based on clinical RCTs have summarized that eration, and multi-professional rehabilitation. This ap- the clinical curative effect of acupuncture treatment in proach is a multi-disciplinary and complex procedure stroke remains uncertain. The reason is the often low designed to improve functional disability, prevent com- quality of the available trials; further large-scale RCTs of plications, and reduce the risk of additional attacks at better quality are still needed. Furthermore, system any stage of stroke [10, 11]. In China, stroke rehabilita- reviews [26, 27] based on scalp acupuncture treatment of tion mainly develops the clinical mode of combining motor dysfunction in stroke concluded that the evidence traditional Chinese medicine and western medicine. was insufficient to warrant a clinical recommendation due Acupuncture use as a complementary or alternative to the generally low methodological quality of the in- therapy has increased worldwide and has become widely cluded studies. In addition, there was no evidence avail- applied to stroke rehabilitation over the last decade able on the safety of this treatment because none of the [12, 13], which confirms that the efficacy of acupuncture trials reported adverse effects. can have a great impact on stroke management [14]. As At the same time, almost all the RCTs used the evalu- early as 1997, the National Institutes of Health (NIH) ation system of modern medicine, and based on the panel recommended acupuncture as a complementary evaluation system of modern medicine, the clinical cura- rehabilitation treatment for stroke [15]. In 2002, the tive effect of acupuncture treatment for stroke has some World Health Organization (WHO) also recommended limitations. For example, many motor function assess- acupuncture as a treatment for stroke; they thought that ment scales do not accurately reflect the actual curative acupuncture treatment could improve a variety of func- effect of acupuncture based on the syndrome differenti- tional disabilities such as motor, sensation, speech, and ation of traditional Chinese medicine (TCM) in a certain other neurologic functions [16]. stage of stroke. Thus, we need to use TCM scales based Many studies [17] have shown that scalp acupuncture on TCM symptomatology to effectively evaluate the has a remarkable treatment efficacy on motor dysfunc- curative effect of acupuncture. It is worth considering tion in stroke patients in China, and in recent years, the best way to solve the issue of how to apply standard- various scalp acupuncture schools have been developed ized RCTs to accurately evaluate the individualized Wang et al. Trials (2017) 18:287 Page 3 of 11 curative effect of acupuncture treatment based on the Traditional Chinese Medicine. Stroke patients with motor theory of TCM in patients with stroke. dysfunction meeting the inclusion criteria will be allocated Based on the above, the purpose of this study is to ob- by a 1:1 ratio into either an acupuncture treatment group serve the therapeutic effect of scalp acupuncture using or a control group. Stroke patients in the control group will Jiao's motor area for motor dysfunction in ischemic receive conventional rehabilitation treatment, whereas a stroke patients by using both international general evalu- combination of Jao’s scalp acupuncture and conventional ation scales and the TCM evaluation system. rehabilitation treatment will be applied to the acupuncture group. The Fugl-Meyer Assessment (FMA) scale will be Methods/design assessed as the primary outcome measure. The Modified Objectives Barthel Index (MBI), the Stroke-Specific Quality of Life The objective of this proposed study is to investigate whether (SS-QOL), and the Stroke Syndrome of Traditional Chinese Jiao's scalp acupuncture treatment could improve signifi- Medicine (SSTCM) scales will be selected as secondary cantly motor function in patients with ischemic stroke. outcome measurements. All assessments will be conducted at baseline, week 4 (treatment 20), week 8 (treatment 40), Study design week 12 (follow-up), and week 16 (follow-up). Figure 1 This is an outcome assessor- and data analyst-blinded, ran- summarizesthe flow of theentiretrial.Figure2showsthe domized controlled study. The study is planned to be study timeline, according to the Standard Protocol Items: conducted from 1 January 2015 to 31 December 2016 in Recommendations for Interventional Trials (SPIRIT) LonghuaHospitalaffiliated with theShanghaiUniversityof diagram. Additional file 1 presents the SPIRIT checklist. Fig. 1 Consolidated Standards of Reporting Trials (CONSORT) flow diagram showing subject allocation to the study conditions (TG, treatment group; CG, control group; FMA, Fugl-Meyer Assessment; MBI, Modified Barthel Index; SS-QOL, Stroke-Specific Quality of Life Scale; SSTCM, Stroke Syndrome of Traditional Chinese Medicine) Wang et al. Trials (2017) 18:287 Page 4 of 11 Fig. 2 SPIRIT figure Inclusion criteria (3) impaired hepatic or renal function; (4) bleeding ten- Participants meeting the following inclusion criteria will dencies; (5) oversensitivity to acupuncture; (6) participa- be included: (1) Stroke patients between 40 and 70 years tion in another clinical trial. old; (2) stroke was diagnosed according to the criteria of cerebral arterial thrombosis in western medicine, and Informed consent apoplexy in Chinese medicine; (3) ischemic stroke con- Prior to the study, the general study process will be ex- firmed by a brain computed tomography (CT) or mag- plained at participant recruitment. Participants will be netic resonance imaging (MRI) scan, where patient has a informed that participation in the trial is absolutely vol- stable medical condition and clear awareness; (4) patient untary and that they can withdraw from the trial at any experienced a recent stroke, between 1 month to time. In the event of their withdrawal, study data col- 6 months after onset; (5) stroke with limb motor dys- lected on the participant will not be deleted and will be function; (6) sufficient cognition to follow commands used in the final analyses. Written informed consent will and Mini-Mental State Examination (MMSE) score >24; be obtained from each participant before they undergo (7) voluntary participation and informed consent signed. any interventions related to the study. Exclusion criteria Interventions Participants with any of the following exclusion criteria The study is a randomized clinical trial carried out in will be excluded: (1) stroke with conscious disturbance the inpatient and outpatient rehabilitation departments or serious cognitive impairment; (2) presence of another of two hospitals. A total of 108 patients with ischemic chronic disorder, including severe Parkinson’s disease, stroke will be recruited. The patients will be randomly cardiac disease, cancers, epilepsy, or chronic alcoholism; assigned to two different groups: (1) the treatment group Wang et al. Trials (2017) 18:287 Page 5 of 11 and (2) the control group. The treatment group (n = 54) will receive Jiao’s scalp acupuncture combined with re- habilitation treatment five times per week for 8 weeks, and the control group (n = 54) will receive rehabilitation treatment five times per week for 8 weeks. Both groups will be evaluated at baseline, week 4 (treatment 20), week 8 (treatment 40) week, week 12 (follow-up), and week 16 (follow-up). Both groups will receive conven- tional stroke rehabilitation treatment during the whole 8-week study period. The rehabilitation program was de- signed according to the Chinese stroke rehabilitation treatment guidelines, which include physical therapy (PT) and occupational therapy (OT) for 5 days a week [28]. Western medicine will be permitted for conventional symptomatic treatment (e.g., antihypertensive drugs, drugs to regulate blood sugar, lipid-lowering drugs, and drugs to inhibit platelet aggregation). Chinese herbal medicine and Fig. 3 The motor area of Jiao’s scalp acupuncture Chinese patent drugs will be prohibited during the trial. (2)Acupuncture manipulation: Disposable stainless steel Scalp acupuncture treatment needles (size 0.25 mm × 40 mm, Huatuo brand, The acupuncture intervention complies with the manufactured by Suzhou Medical Appliance in Standards for Reporting Interventions in Clinical Trials Suzhou, Jiangsu Province, China) will be manually of Acupuncture (STRICTA) guidelines. Moreover, all inserted at an approximately 15-degree angle to a the acupuncturists will receive special training to depth of 1.0–1.5 cm respectively along the upper achieve a sound understanding of the acupuncture point and middle point of the motor area on the intervention and to normalize the practices across scalp. For treating motor dysfunction, the needles different acupuncturists. The trial adheres to the will be rotated for at least 200 revolutions per STRICTA guidelines [29, 30]. minute for 1 minute every 10 minutes for a total of The parameters for scalp acupuncture are set as 60 minutes. Scalp acupuncture treatment will be follows: performed by an independent certified practitioner (acupuncturist) with 5 years of clinical experience. (1)Location of the motor area of Jiao’sscalp (3)Treatment course: The scalp acupuncture treatment acupuncture: This area is located over the will be implemented five times a week, twenty times anterior central convolution of the cerebral per treatment course, with each patient having two cortex. It is a line starting from a point (known treatment courses in total. as the upper point of the motor area) 0.5 cm posterior to the midpoint of the anterior-posterior Rehabilitation treatment midline of the head and stretching diagonally to The patients will receive the conventional rehabilitation thejuncturebetween theeyebrow-occipital line programs as mentioned above. The rehabilitation pro- and the anterior border of the corner of the grams will be carried out five times a week (that is, temporal hairline, which is indistinct. Draw a Monday through Friday) for 8 weeks, and every time, vertical line upwards from the middle point of the the rehabilitation treatment (PT and OT) will last for ap- zygomatic arch to the eyebrow-occipital line; the proximately 1 hour. All rehabilitation treatments will be intersection of the two lines is the projection of carried out by qualified therapists. the motor area. The motor area is divided into five equal parts: the upper one-fifth being the Follow-up motorareaofthe lower limbs and the trunk, the After the 8-week treatment observation, all patients will middle two-fifths being the motor area of the start an additional 8-week follow-up period. Because of upper limbs, and the lower two fifths the motor the specificity of stroke patients’ recovery, patients from area of the face (Fig. 3 shows the motor area of both groups will need to attend community-based re- Jiao’s scalp acupuncture). The motor area of the habilitation treatment during the follow-up period. How- cerebral infarction lesion’sside isselectedasthe ever, scalp acupuncture treatment is not permitted for site for acupuncture treatment. stroke patients in both groups during the community- Wang et al. Trials (2017) 18:287 Page 6 of 11 based rehabilitation period. During the 8-week follow-up adequate training program, and a competency assess- period, all of the patients from both groups will be reas- ment for study raters to ensure rater competence across sessed using the FMA, MBI, SSTCM, and SS-QOL at the duration of the trial. The FMA will be assessed at week 12 and week 16 and will be asked to fill out forms baseline, during the interventions period (at 4 weeks and to record their rehabilitation treatment attendance. All 8 weeks), and during the follow-up period (at 12 weeks assessment scales and forms will be returned to the re- and 16 weeks). searchers for reviewing at the end of the trial. Secondary outcome measures Outcome measures Modified Barthel Index (MBI) Data collection will be performed by a trained assessor The Barthel Index is a scale that measures ten basic as- who is blind to patients’ assignment at baseline, after the pects of daily life activities related to self-care and mo- intervention (4 weeks, 8 weeks), and at the end of bility [41]. For the Chinese MBI version, the ten items follow-up (12 weeks, 16 weeks). are continence of bowels and bladder, feeding, dressing, entering and leaving a toilet, grooming, bathing, moving Basic characteristic variables from a wheelchair to a bed and returning to a wheel- All of the participants’ general status demographic infor- chair, walking on a level surface for 45 m, and ascending mation such as age, sex, educational background, marital and descending stairs. The standards for evaluation are status, working condition, and time since attack will be as follows. Each item (activity) can be divided into five attained from baseline questionnaires. Vital signs (pulse, levels; each level represents a different degree of inde- respiration rate, temperature, and blood pressure) will pendence, the lowest level being 1 and the highest being be measured by nurses. 5, and the higher the level, the greater the independence. The normal score is 100. If a person’s score is 100, he is Primary outcome measurement able to get along without attendant care. The MBI will Fugl-Meyer Assessment (FMA) be assessed at baseline, during the interventional period The FMA scale for motor function was developed as the (at 4 weeks and 8 weeks), and during the follow-up first quantitative evaluative instrument for measuring period (at 12 weeks and 16 weeks). sensorimotor stroke recovery, which includes an assess- ment of the upper extremities (UE, 33 items) and lower Stroke-Specific Quality of Life (SS-QOL) scale extremities (LE, 17 items) [31]. The FMA scale includes The SS-QOL is a patient-reported outcome measure flexor synergy, extensor synergy, movement combining intended to provide an assessment of health-related synergies, movement out of synergy, wrist, hand, and co- quality of life, specific to patients with stroke [42]. The ordination/speed. The motor FM assessments are scored SS-QOL questionnaire consists of 49 items in the 12 on a 3-point ordinal scale (0–2). Each item can be di- domains of energy, family roles, language, mobility, vided into three levels, the lowest level being 0 point, mood, personality, self-care, social roles, thinking, upper the highest being 2 points, and level between the two in- extremity function, vision, and work. Scoring on the SS- dicated with 1 point. The FM motor assessment is used QOL is rated on a 5-point Likert scale. Response options to measure voluntary limb movement. It includes the are scored as 5 (“no help needed/no trouble at all/ UE subscale (33 items; score range 0–66) and the LE strongly disagree”), 4 (“a little help/a little trouble/ subscale (17 items; score range 0–34) for a total motor moderately disagree”), 3 (“some help/some trouble/ FM score of 100 [32]. neitheragree nordisagree”), 2 (“a lot of help/a lot of The assessment is performed in a quiet area when the trouble/moderately agree”), and 1 (“total help/could patient is maximally alert. The motor domain has well- not do it at all/strongly agree”). The domains are established reliability and validity as an indicator of scored separately; a total score is also calculated, with motor impairment severity across different stroke recov- higher scores indicating better function. The SS-QOL ery time points [33, 34]. The clinical value of the FM as- will be assessed at baseline, during the interventional sessment is that it provides a hierarchical scale of motor period (at 4 weeks and 8 weeks), and during the impairment severity; low FM scores indicate greater im- follow-up period (at 12 weeks and 16 weeks). pairment. A higher FM score for the UE or LE is a clin- ical indicator of less motor impairment [35, 36]. The Stroke Syndrome of TCM (SSTCM) minimal clinically important difference (MCID) values The SSTCM was developed mainly based on a quantified [37–39] of the Chinese version of the FMA in motor do- index of TCM symptoms. The SSTCM includes signs main in patients with stroke are 4.58 for UE, 3.31 for and symptoms which cause the most concern for pa- LE, and 6.0 for UE plus LE [40]. We set up a standard- tients and doctors after stroke. SSTCM mainly consists ized procedure for the FM motor assessments, an of two domains: TCM symptoms, and pulse conditions Wang et al. Trials (2017) 18:287 Page 7 of 11 and tongue pictures. The TCM symptoms area contains control to ensure the accuracy of the data. The second 24 items. The assessment standards of each item are level of data integrity will include data monitoring and divided into four levels and corresponding scores validation, which will be conducted on a regular basis (normal = 0, light = 1, middle = 2, heavy = 3), based on throughout the study. The original CRFs and all other the severity of the symptoms and their impact on life. forms (including the consent forms) will be archived se- Pulse conditions and tongue pictures are simply re- curely in the clinical research center of Longhua corded and have no impact on the score. The total score Hospital, affiliated with the Shanghai University of TCM is calculated using only the first domain, with lower for 5 years following publication of the last paper or re- scores indicating a lighter degree of symptom severity port from the study. and a less significant impact on life [43, 44]. Experienced The safety of the study will be monitored by a Data doctors of TCM who accepted the unification of the and Safety Monitoring Board (DSMB) of the clinical assessment training evaluated the SSTCM. The SSTCM evaluation center of Longhua Hospital, affiliated with will be assessed at baseline, during the interventional Shanghai University of TCM, which consists of inde- period (at 4 weeks and 8 weeks), and during the follow- pendent clinical experts and statisticians with access to up period (at 12 weeks and 16 weeks). unblinded data. The DSMB is independent from the sponsor, the competing interests, and the investigational Safety site and will review the performance and safety of the We will conduct the following tests on all participants at trial monthly. the screening stage to exclude patients with serious The criteria for unblinding and discontinuing allo- organic lesions: white blood cells, platelets, hemoglobin, cated interventions for a given trial participant in- alanine aminotransferase/aspartate aminotransferase, clude having a recurrent stroke, having serious gamma-glutamyl transpeptidase, creatinine, and blood complications of stroke or experiencing serious urea nitrogen. acupuncture-related AEs (if any), which have been de- The subjects will be requested to report information scribed previously. The DSMB will reveal a partici- about adverse events (AEs). All AEs that occur during pant’s allocated intervention and make the final the trial period will be recorded, such as sweating, pallor, decision to terminate the trial. dizziness, fainting, perturbed or chest congestion during The final trial data set will be under the custody of acupuncture treatment, local hematoma, bleeding, un- Longhua Hospital/Shanghai University of TCM. The bearable prickling, local anaphylaxis, retained needle data manager from the clinical evaluation center of after treatment, and continuous severe local pain for Longhua Hospital will have access to the complete, an- more than one hour after acupuncture. The researcher onymous final data set. Access to the final data set or will confirm the occurrence of AEs and record all details identifiable data by others will require written requests such as the time of occurrence, date, degree, measure- to be approved by the DSMB of the clinical evaluation ment related to the acupuncture treatment, and causal center of Longhua Hospital/Shanghai University of TCM relationship with the acupuncture treatment. Serious and all study investigators. AEs must be reported to the principal investigator immediately. Sample size calculation The sample size was determined using the results of our Quality control previous clinical trial and pilot trial [45–47]. The pri- Before the trial, all staff members are required to attend mary efficacy parameter is the change in FMA scores a series of training sessions. These sessions will ensure from baseline to the end of treatment after 8 weeks. Ac- that the personnel involved fully understand the research cording to our preliminary test and previous study, the protocol and standard operating procedures for the primary efficacy parameter (FMA score) of the control study. To maintain the clinical trial at a consistently high group (rehabilitation treatment) would be increased by quality, the clinical research center of Longhua Hospital 9.86, and that of the treatment group (scalp acupuncture will monitor the study file, informed consent forms, case combination rehabilitation treatment) would be in- report forms (CRFs), serious AEs, and data records creased by 19.12. The FMA average standard deviation regularly. would be approximately 7.64. A two-sided 5% significance level and 90% power were considered, and the above rele- Data collection, management, and monitoring vant data (9.86, 19.12, 7.64, α =0.05, 1 – β =0.9) were The CRF, Treatment Form, and Adverse Events Form input into NCSS-PASS V11.0.7 software (https:// will be first completed and then double-entered into the www.ncss.com/software/pass/) [48]. On the basis of the electronic data capture (EDC) system electronically by software calculation, approximately 45 participants are re- two independent investigators to act as the first level of quired in each group in order to have a sufficient sample Wang et al. Trials (2017) 18:287 Page 8 of 11 size. With an estimated dropout rate of 20%, each group is medians with ranges, and non-parametric tests will be required to have 54 initial participants. used. Categorical variables will be expressed as number (%) and analyzed by χ test or Fisher’s exact test. De- Participant recruitment scriptive statistics will be used to detail baseline partici- Participants will be recruited from two hospitals pant demographics and general status characteristics of (Longhua Hospital affiliated with the Shanghai University patients, such as gender, age, disease course, hemiplegia of Traditional Chinese Medicine and the Shanghai (left or right), stroke risk factors, and diseased location Changning District Tianshan Traditional Chinese and size. Repeated measures analysis of variance Medicine Hospital, which is a Longhua Hospital (ANOVA) will be used to analyze value changes of branch) in Shanghai, China. Our study will be propa- FMA, MBI, SS-QOL, and SSTCM scores across five test- gated via the Internet, local health-related newspa- ing time points (weeks 0, 4, 8, 12, and 16). Safety ana- pers, and posters in communities and hospitals. lyses will be compared with the incidence of AEs in the Prospective participants will be asked to talk face to two groups using the χ test. face with study coordinators to discuss the study and provide information regarding eligibility criteria. If pa- Discussion tients are eligible and interested in participating, they Chinese scalp acupuncture is a contemporary acupunc- will be invited for a series of rehabilitation assess- ture technique integrating traditional Chinese needling ments after diagnosis by neurologists. One hundred methods with western medical knowledge of representa- and eight patients will be included in the study. tive areas of the cerebral cortex. As acupuncture was de- When their informed consent has been obtained, pa- veloping, various physicians began to introduce western tients will be randomized into two groups with differ- neurophysiology into the field of acupuncture and ex- ent treatments. plored correlations between the brain and human body. Dr. Jiao Shun-fa, who is the founder of Jiao’s scalp acu- Randomization and allocation concealment puncture and a neurosurgeon in Shan Xi Province, is Prior to treatment, each patient will be randomly also the recognized founder of Chinese scalp acupunc- assigned one serial number using a software program. ture. Dr. Jiao combined the modern understanding of Assignments will be sealed in opaque envelopes and will neurophysiology and neuroanatomy with the traditional be opened by the researchers following informed con- concept of acupuncture to develop the new scalp acu- sent procedures and baseline testing. All rehabilitation puncture utilized to affect the functions of the central therapists, assessors, and analysts will be blinded to nervous system. Scalp acupuncture uses special tech- group assignments. niques to harmonize and regulate the functional activ- ities of the brain and body. Many researches on scalp Statistical analysis acupuncture have indicated positive results in treating All data will be analyzed in the clinical research center various disorders of the central nervous system. Stroke of Longhua Hospital, affiliated with the Shanghai is one of the most common diseases for which acupunc- University of TCM by statisticians using the Statistical ture treatment is recommended, according to the WHO Product and Service Solutions (SPSS ) statistical package [49]. In view of the motor dysfunction that occurs post- program (version 17.0, SPSS Inc., Chicago, IL, USA). stroke, the upper one-fifth and middle two-fifths of the Baseline assessments will be conducted before motor area on the scalp were selected as the primary randomization, including gender and age of patients, area for the scalp acupuncture stimulation region. disease course, hemiplegia (left or right), stroke risk In stroke rehabilitation clinical studies, rehabilitation factors, diseased location and size, primary outcome evaluation plays an important role. The FMA and MBI (FMA), and secondary outcomes (MBI, SS-QOL, and were selected as the gold standards for the evaluation of SSTCM). All patients randomized to each group are acupuncture treatment’s curative effect in almost all acu- included in the analysis, and the data analysis will be puncture treatment stroke researches, both domestically conducted using two-sided significance tests at a 5% and overseas. We used the FMA scale to best observe significance level. All analyses will be based on the the comprehensive motor ability of stroke patients based intention-to-treat principle using the last observation on the specific environments and the corresponding in- carried forward rule. Missing values will be handled by structions; the FMA reflects the motor dysfunction level the mixed model for repeated measurements. Continu- of stroke patients and is widely applied in the evaluation ous variables with normal distribution will be expressed of motor dysfunction after stroke [50]. The MBI was as means with standard deviations (SDs) and compared used as an individual-level assessment scale to evaluate by an independent sample Student t test. For abnormally daily life activities of stroke patients; it responds to the distributed variables, the data will be expressed as complex activity ability and necessary functional skills of Wang et al. Trials (2017) 18:287 Page 9 of 11 patients in daily environments and is often used to as- Trial status sess the degree of influence of motor dysfunction in This study has been completed. families and social environments [51]. However, in Chinese medicine, stroke itself is thought to involve sev- Additional file eral interpromoting disease mechanisms, possibly in- cluding qi stagnation, heat, phlegm, blood stasis, and Additional file 1: SPIRIT checklist. (DOC 127 kb) wind. Hence, the common name for stroke in Chinese medicine is wind stroke. According to the “four diagnos- Abbreviations tic methods” of TCM, the syndrome changes in stroke CG: Control group; CRF: Case report form; DSMB: Data and Safety Monitoring Board; EDC: Electronic data capture; FMA: Fugl-Meyer Assessment; LE: Lower patients are in a dynamic development process. These extremities; MBI: Modified Barthel Index; MCID: Minimal clinically important symptoms’ academic terminologies are not relevant to difference; MMSE: Mini-Mental State Examination; NIH: National Institutes of the understanding of western traditional medicine for Health; RCT: Randomized controlled trial; SS-QOL: Stroke-Specific Quality of Life (scale); SSTCM: Stroke Syndrome of Traditional Chinese Medicine; the symptoms of stroke diagnosis, including hemiplegia, TCM: Traditional Chinese medicine; TG: Treatment group; UE: Upper aphasia, and facial nerve paralysis, etc. [52]. Many motor extremities function assessment scales do not accurately reflect the actual curative effect of acupuncture based on syndrome Acknowledgements We would like to thank all patients and doctors who participated in this trial differentiation of TCM in a certain stage of stroke. The for their cooperation. We also would like to express our gratitude to four study of acupuncture treatment of stroke should fully re- graduate students who contributed their time and effort to the preliminary flect and embody the characteristics of TCM [53]. It study (Minghang Yan, Lijun Shi, Yiwen Cai, and Yuhong Ma). needs to develop the evaluation standard of acupunc- ture’s curative effect based on TCM symptomatology. It Funding This article was supported by grants from the Shanghai Municipal Health is not conducive to reasonably judge the effectiveness of and Family Planning Research Center of Traditional Chinese Medicine acupuncture intervention based on the priority of Schools heritage project funding (project number: ZY3-CCCX-1-1007), “syndrome differentiation” because of the lack of an Shanghai Science and Technology Committee key research project funding (project number: 16401970300), and Shanghai Municipal Health and Family appropriate therapeutic effect evaluation standard of Planning Commission of Traditional Chinese Medicine project funding syndromes. However, SSTCM in this research con- (project number: 2014LQ021A). forms to the TCM identification rule of similar syn- dromes and highlights the advantages and characteristics Availability of data and materials Not applicable. of TCM [54, 55]. Acupuncture is a frequently used therapy for stroke Authors’ contributions rehabilitation in China, but the evidence of its effect JW and JP conceived and designed the study, collected the data, and wrote from previous studies seems to be inconclusive [56]. the manuscript. DK revised the manuscript. QHF, XC, and YS analyzed and interpreted the data. MHY, LJS, YWC, and YHM collected the data and Some systematic reviews have been done to study the ef- coordinated recruitment and treatment of patients. All authors read and fect of acupuncture on stroke rehabilitation [14, 25, 57, approved the final manuscript. 58]. These reviews have drawn consistent conclusions that acupuncture appears to be safe and effective for Competing interests The authors declare that they have no competing interests. stroke rehabilitation, but the benefits require further confirmation with larger, more transparent and well- Consent for publication conducted randomized clinical trials. Thus, the purpose Not applicable. of this research is to observe the therapeutic effect of scalp acupuncture using Jiao’s motor area for motor Ethics approval and consent to participate The research protocol has been approved (number 2013LCSY056) by the dysfunction in patients with ischemic stroke according Research Ethical Committee of the Affiliated Longhua Hospital of Shanghai to both international general evaluation scales and TCM University Traditional Chinese Medicine and Shanghai Changning District evaluation systems. Tianshan Hospital of Traditional Chinese Medicine (Longhua Hospital Branch). In the case of any changes to the study protocol, we will submit a written Under strict quality control, this study could poten- application form to the Research Ethics Committee. They will decide tially confirm whether or not scalp acupuncture on a whether or not it is necessary to change the study protocol. The Research motor area is an effective adjunct to the standard re- Ethics Committee will supervise all procedures of the study. The purpose and risks of the trial will be explained in detail to the participants, who will habilitation treatment for stroke patients with motor be required to write informed consent to indicate that they agree with the dysfunction. This study also aims to explore the correl- protocol and would participate in the trial. The participants will be able to ation between the TCM symptoms improved and the quit at any time during the study period. motor function recovery for patients with stroke, which is of great significance in further improving the evalu- Publisher’sNote ation system of acupuncture treatment on motor Springer Nature remains neutral with regard to jurisdictional claims in dysfunction in these patients. published maps and institutional affiliations. Wang et al. Trials (2017) 18:287 Page 10 of 11 Author details 21. Wu HM, Tang JL, Lin XP, et al. 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Neuro Epidemiol. 2014;42:50–8. 58 Wu HM, Tang JL, Lin XP, Lau J, Leung PC, Woo J, Li YP. Acupuncture for stroke rehabilitation. Cochrane Database Syst Rev. 2006;39(3):CD004131. Submit your next manuscript to BioMed Central and we will help you at every step: • We accept pre-submission inquiries � Our selector tool helps you to find the most relevant journal � We provide round the clock customer support � Convenient online submission � Thorough peer review � Inclusion in PubMed and all major indexing services � Maximum visibility for your research Submit your manuscript at www.biomedcentral.com/submit http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Trials Springer Journals

Acupuncture treatment on the motor area of the scalp for motor dysfunction in patients with ischemic stroke: study protocol for a randomized controlled trial

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Springer Journals
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2017 The Author(s).
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1745-6215
DOI
10.1186/s13063-017-2000-x
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Abstract

Background: Scalp acupuncture has shown a remarkable treatment efficacy on motor dysfunction in patients with stroke in China, especially the motor area of Jiao’s scalp acupuncture, which is the most widely used treatment. However, previous studies have summarized that the clinical curative effect of acupuncture treatment for stroke remains uncertain. Meanwhile, no randomized controlled trials on Jiao’s scalp acupuncture have been performed. The aim of this study is to evaluate the efficacy and safety of Jiao’s scalp acupuncture for motor dysfunction in ischemic stroke. Methods/design: This is an assessor- and analyst-blinded, randomized controlled trial. One hundred and eight stroke patients with motor dysfunction meeting the inclusion criteria will be allocated by a 1:1 ratio into either an acupuncture treatment group or a control group. Stroke patients in the control group will receive conventional rehabilitation treatment, whereas a combination of Jiao’s scalp acupuncture and conventional rehabilitation treatment will be applied to the acupuncture group. Forty treatment sessions will be performed over an 8-week period. The Fugl-Meyer Assessment scale will be assessed as the primary outcome measure. The Modified Barthel Index, the Stroke-Specific Quality of Life, and the Stroke Syndrome of Traditional Chinese Medicine scales will be selected as secondary outcome measurements. All assessments will be conducted at baseline, week 4 (treatment 20), week 8 (treatment 40), week 12 (follow-up), and week 16 (follow-up). Discussion: This is the first trial evaluating the efficacy and safety of Jiao’s scalp acupuncture for motor dysfunction in ischemic stroke. The results of this trial are expected to provide relevant evidence demonstrating that Jiao’sscalp acupuncture can be used as an effective rehabilitation treatment method for improving motor dysfunction in ischemic stroke. Trial registration: ClinicalTrials.gov, NCT02871453. Registered on 17 July 2016. Keywords: Ischemic stroke, Motor dysfunction, Jiao’s scalp acupuncture, Study protocol * Correspondence: 13512183795@163.com; jianpei99@yahoo.com Department of Acupuncture, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, No. 725 South WanPing Road, XuHui District, Shanghai 200032, China Full list of author information is available at the end of the article © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Wang et al. Trials (2017) 18:287 Page 2 of 11 Background to treat motor dysfunction in stroke patients in hospi- The epidemic survey data from the Global Burden of tals. The motor area of Jiao’s scalp acupuncture or the Diseases, Injuries, and Risk Factors Study (GBD 2010) anterior oblique line of the vertex-tempora of the inter- ranked stroke as the second most common cause of national standardized scalp partition is usually selected death, the most common cause of disability [1], and the as the scalp acupuncture stimulatory region to treat third most common cause of disability-adjusted life years motor dysfunction in stroke patients; however, Jiao’s (DALYs) worldwide [2]. Over the past two decades, the scalp acupuncture is the more widely used of the two absolute number of people with first stroke (16.9 mil- techniques [18]. Jiao’s scalp acupuncture combines a lion), stroke survivors (33 million), and stroke-related modern understanding of neuroanatomy and neuro- deaths (5.9 million) and the overall global burden of physiology with traditional techniques of Chinese acu- stroke (DALYs lost, 102 million) have been on the rise puncture to develop a radical new tool for affecting the [3]. Statistics from the American Heart Association show functions of the central nervous system and accepts a that approximately 795,000 people experience a new or central theory that incorporates brain functions into recurrent stroke each year [4]. In China, stroke is re- Chinese medicine principles. The motor area of Jiao’s ported as one of the most common causes of death in scalp acupuncture that is specifically used for treatment both urban and rural areas [5, 6]. An epidemiologic of motor dysfunction after stroke is equivalent to the study published in 2007 indicates that China has more structure of the precentral gyrus of the cerebral cortex than 7 million stroke survivors. Ischemic stroke is the on the scalp projection [19]. However, no randomized most common subtype of stroke, accounting for about controlled trials (RCTs) have been performed to demon- 80% of all strokes. Approximately 70% of stroke survi- strate the clinical curative effect of the motor area of vors experience functional disabilities, motor dysfunc- Jiao’s scalp acupuncture treatment on motor dysfunction tion being the most significant symptom [7, 8]. The in patients with stroke. activities of daily living and social participation are lim- Moreover, with the rapid development of evidence- ited in patients with stroke due to motor dysfunction; based medicine, any clinical intervention strategies this greatly influences the patient’s quality of life and re- which are used must be backed by a high level of turn to society. Also, these limitations place a heavy bur- evidence-based support. Although acupuncture as a den on the family and society as a whole, becoming a treatment for stroke has become widely accepted and huge public health problem [9]. has shown a better clinical curative effect than con- Western conventional treatment of patients with ventional treatments, numerous meta-analysis reviews stroke includes pharmacological treatments, surgical op- [14, 20–25] based on clinical RCTs have summarized that eration, and multi-professional rehabilitation. This ap- the clinical curative effect of acupuncture treatment in proach is a multi-disciplinary and complex procedure stroke remains uncertain. The reason is the often low designed to improve functional disability, prevent com- quality of the available trials; further large-scale RCTs of plications, and reduce the risk of additional attacks at better quality are still needed. Furthermore, system any stage of stroke [10, 11]. In China, stroke rehabilita- reviews [26, 27] based on scalp acupuncture treatment of tion mainly develops the clinical mode of combining motor dysfunction in stroke concluded that the evidence traditional Chinese medicine and western medicine. was insufficient to warrant a clinical recommendation due Acupuncture use as a complementary or alternative to the generally low methodological quality of the in- therapy has increased worldwide and has become widely cluded studies. In addition, there was no evidence avail- applied to stroke rehabilitation over the last decade able on the safety of this treatment because none of the [12, 13], which confirms that the efficacy of acupuncture trials reported adverse effects. can have a great impact on stroke management [14]. As At the same time, almost all the RCTs used the evalu- early as 1997, the National Institutes of Health (NIH) ation system of modern medicine, and based on the panel recommended acupuncture as a complementary evaluation system of modern medicine, the clinical cura- rehabilitation treatment for stroke [15]. In 2002, the tive effect of acupuncture treatment for stroke has some World Health Organization (WHO) also recommended limitations. For example, many motor function assess- acupuncture as a treatment for stroke; they thought that ment scales do not accurately reflect the actual curative acupuncture treatment could improve a variety of func- effect of acupuncture based on the syndrome differenti- tional disabilities such as motor, sensation, speech, and ation of traditional Chinese medicine (TCM) in a certain other neurologic functions [16]. stage of stroke. Thus, we need to use TCM scales based Many studies [17] have shown that scalp acupuncture on TCM symptomatology to effectively evaluate the has a remarkable treatment efficacy on motor dysfunc- curative effect of acupuncture. It is worth considering tion in stroke patients in China, and in recent years, the best way to solve the issue of how to apply standard- various scalp acupuncture schools have been developed ized RCTs to accurately evaluate the individualized Wang et al. Trials (2017) 18:287 Page 3 of 11 curative effect of acupuncture treatment based on the Traditional Chinese Medicine. Stroke patients with motor theory of TCM in patients with stroke. dysfunction meeting the inclusion criteria will be allocated Based on the above, the purpose of this study is to ob- by a 1:1 ratio into either an acupuncture treatment group serve the therapeutic effect of scalp acupuncture using or a control group. Stroke patients in the control group will Jiao's motor area for motor dysfunction in ischemic receive conventional rehabilitation treatment, whereas a stroke patients by using both international general evalu- combination of Jao’s scalp acupuncture and conventional ation scales and the TCM evaluation system. rehabilitation treatment will be applied to the acupuncture group. The Fugl-Meyer Assessment (FMA) scale will be Methods/design assessed as the primary outcome measure. The Modified Objectives Barthel Index (MBI), the Stroke-Specific Quality of Life The objective of this proposed study is to investigate whether (SS-QOL), and the Stroke Syndrome of Traditional Chinese Jiao's scalp acupuncture treatment could improve signifi- Medicine (SSTCM) scales will be selected as secondary cantly motor function in patients with ischemic stroke. outcome measurements. All assessments will be conducted at baseline, week 4 (treatment 20), week 8 (treatment 40), Study design week 12 (follow-up), and week 16 (follow-up). Figure 1 This is an outcome assessor- and data analyst-blinded, ran- summarizesthe flow of theentiretrial.Figure2showsthe domized controlled study. The study is planned to be study timeline, according to the Standard Protocol Items: conducted from 1 January 2015 to 31 December 2016 in Recommendations for Interventional Trials (SPIRIT) LonghuaHospitalaffiliated with theShanghaiUniversityof diagram. Additional file 1 presents the SPIRIT checklist. Fig. 1 Consolidated Standards of Reporting Trials (CONSORT) flow diagram showing subject allocation to the study conditions (TG, treatment group; CG, control group; FMA, Fugl-Meyer Assessment; MBI, Modified Barthel Index; SS-QOL, Stroke-Specific Quality of Life Scale; SSTCM, Stroke Syndrome of Traditional Chinese Medicine) Wang et al. Trials (2017) 18:287 Page 4 of 11 Fig. 2 SPIRIT figure Inclusion criteria (3) impaired hepatic or renal function; (4) bleeding ten- Participants meeting the following inclusion criteria will dencies; (5) oversensitivity to acupuncture; (6) participa- be included: (1) Stroke patients between 40 and 70 years tion in another clinical trial. old; (2) stroke was diagnosed according to the criteria of cerebral arterial thrombosis in western medicine, and Informed consent apoplexy in Chinese medicine; (3) ischemic stroke con- Prior to the study, the general study process will be ex- firmed by a brain computed tomography (CT) or mag- plained at participant recruitment. Participants will be netic resonance imaging (MRI) scan, where patient has a informed that participation in the trial is absolutely vol- stable medical condition and clear awareness; (4) patient untary and that they can withdraw from the trial at any experienced a recent stroke, between 1 month to time. In the event of their withdrawal, study data col- 6 months after onset; (5) stroke with limb motor dys- lected on the participant will not be deleted and will be function; (6) sufficient cognition to follow commands used in the final analyses. Written informed consent will and Mini-Mental State Examination (MMSE) score >24; be obtained from each participant before they undergo (7) voluntary participation and informed consent signed. any interventions related to the study. Exclusion criteria Interventions Participants with any of the following exclusion criteria The study is a randomized clinical trial carried out in will be excluded: (1) stroke with conscious disturbance the inpatient and outpatient rehabilitation departments or serious cognitive impairment; (2) presence of another of two hospitals. A total of 108 patients with ischemic chronic disorder, including severe Parkinson’s disease, stroke will be recruited. The patients will be randomly cardiac disease, cancers, epilepsy, or chronic alcoholism; assigned to two different groups: (1) the treatment group Wang et al. Trials (2017) 18:287 Page 5 of 11 and (2) the control group. The treatment group (n = 54) will receive Jiao’s scalp acupuncture combined with re- habilitation treatment five times per week for 8 weeks, and the control group (n = 54) will receive rehabilitation treatment five times per week for 8 weeks. Both groups will be evaluated at baseline, week 4 (treatment 20), week 8 (treatment 40) week, week 12 (follow-up), and week 16 (follow-up). Both groups will receive conven- tional stroke rehabilitation treatment during the whole 8-week study period. The rehabilitation program was de- signed according to the Chinese stroke rehabilitation treatment guidelines, which include physical therapy (PT) and occupational therapy (OT) for 5 days a week [28]. Western medicine will be permitted for conventional symptomatic treatment (e.g., antihypertensive drugs, drugs to regulate blood sugar, lipid-lowering drugs, and drugs to inhibit platelet aggregation). Chinese herbal medicine and Fig. 3 The motor area of Jiao’s scalp acupuncture Chinese patent drugs will be prohibited during the trial. (2)Acupuncture manipulation: Disposable stainless steel Scalp acupuncture treatment needles (size 0.25 mm × 40 mm, Huatuo brand, The acupuncture intervention complies with the manufactured by Suzhou Medical Appliance in Standards for Reporting Interventions in Clinical Trials Suzhou, Jiangsu Province, China) will be manually of Acupuncture (STRICTA) guidelines. Moreover, all inserted at an approximately 15-degree angle to a the acupuncturists will receive special training to depth of 1.0–1.5 cm respectively along the upper achieve a sound understanding of the acupuncture point and middle point of the motor area on the intervention and to normalize the practices across scalp. For treating motor dysfunction, the needles different acupuncturists. The trial adheres to the will be rotated for at least 200 revolutions per STRICTA guidelines [29, 30]. minute for 1 minute every 10 minutes for a total of The parameters for scalp acupuncture are set as 60 minutes. Scalp acupuncture treatment will be follows: performed by an independent certified practitioner (acupuncturist) with 5 years of clinical experience. (1)Location of the motor area of Jiao’sscalp (3)Treatment course: The scalp acupuncture treatment acupuncture: This area is located over the will be implemented five times a week, twenty times anterior central convolution of the cerebral per treatment course, with each patient having two cortex. It is a line starting from a point (known treatment courses in total. as the upper point of the motor area) 0.5 cm posterior to the midpoint of the anterior-posterior Rehabilitation treatment midline of the head and stretching diagonally to The patients will receive the conventional rehabilitation thejuncturebetween theeyebrow-occipital line programs as mentioned above. The rehabilitation pro- and the anterior border of the corner of the grams will be carried out five times a week (that is, temporal hairline, which is indistinct. Draw a Monday through Friday) for 8 weeks, and every time, vertical line upwards from the middle point of the the rehabilitation treatment (PT and OT) will last for ap- zygomatic arch to the eyebrow-occipital line; the proximately 1 hour. All rehabilitation treatments will be intersection of the two lines is the projection of carried out by qualified therapists. the motor area. The motor area is divided into five equal parts: the upper one-fifth being the Follow-up motorareaofthe lower limbs and the trunk, the After the 8-week treatment observation, all patients will middle two-fifths being the motor area of the start an additional 8-week follow-up period. Because of upper limbs, and the lower two fifths the motor the specificity of stroke patients’ recovery, patients from area of the face (Fig. 3 shows the motor area of both groups will need to attend community-based re- Jiao’s scalp acupuncture). The motor area of the habilitation treatment during the follow-up period. How- cerebral infarction lesion’sside isselectedasthe ever, scalp acupuncture treatment is not permitted for site for acupuncture treatment. stroke patients in both groups during the community- Wang et al. Trials (2017) 18:287 Page 6 of 11 based rehabilitation period. During the 8-week follow-up adequate training program, and a competency assess- period, all of the patients from both groups will be reas- ment for study raters to ensure rater competence across sessed using the FMA, MBI, SSTCM, and SS-QOL at the duration of the trial. The FMA will be assessed at week 12 and week 16 and will be asked to fill out forms baseline, during the interventions period (at 4 weeks and to record their rehabilitation treatment attendance. All 8 weeks), and during the follow-up period (at 12 weeks assessment scales and forms will be returned to the re- and 16 weeks). searchers for reviewing at the end of the trial. Secondary outcome measures Outcome measures Modified Barthel Index (MBI) Data collection will be performed by a trained assessor The Barthel Index is a scale that measures ten basic as- who is blind to patients’ assignment at baseline, after the pects of daily life activities related to self-care and mo- intervention (4 weeks, 8 weeks), and at the end of bility [41]. For the Chinese MBI version, the ten items follow-up (12 weeks, 16 weeks). are continence of bowels and bladder, feeding, dressing, entering and leaving a toilet, grooming, bathing, moving Basic characteristic variables from a wheelchair to a bed and returning to a wheel- All of the participants’ general status demographic infor- chair, walking on a level surface for 45 m, and ascending mation such as age, sex, educational background, marital and descending stairs. The standards for evaluation are status, working condition, and time since attack will be as follows. Each item (activity) can be divided into five attained from baseline questionnaires. Vital signs (pulse, levels; each level represents a different degree of inde- respiration rate, temperature, and blood pressure) will pendence, the lowest level being 1 and the highest being be measured by nurses. 5, and the higher the level, the greater the independence. The normal score is 100. If a person’s score is 100, he is Primary outcome measurement able to get along without attendant care. The MBI will Fugl-Meyer Assessment (FMA) be assessed at baseline, during the interventional period The FMA scale for motor function was developed as the (at 4 weeks and 8 weeks), and during the follow-up first quantitative evaluative instrument for measuring period (at 12 weeks and 16 weeks). sensorimotor stroke recovery, which includes an assess- ment of the upper extremities (UE, 33 items) and lower Stroke-Specific Quality of Life (SS-QOL) scale extremities (LE, 17 items) [31]. The FMA scale includes The SS-QOL is a patient-reported outcome measure flexor synergy, extensor synergy, movement combining intended to provide an assessment of health-related synergies, movement out of synergy, wrist, hand, and co- quality of life, specific to patients with stroke [42]. The ordination/speed. The motor FM assessments are scored SS-QOL questionnaire consists of 49 items in the 12 on a 3-point ordinal scale (0–2). Each item can be di- domains of energy, family roles, language, mobility, vided into three levels, the lowest level being 0 point, mood, personality, self-care, social roles, thinking, upper the highest being 2 points, and level between the two in- extremity function, vision, and work. Scoring on the SS- dicated with 1 point. The FM motor assessment is used QOL is rated on a 5-point Likert scale. Response options to measure voluntary limb movement. It includes the are scored as 5 (“no help needed/no trouble at all/ UE subscale (33 items; score range 0–66) and the LE strongly disagree”), 4 (“a little help/a little trouble/ subscale (17 items; score range 0–34) for a total motor moderately disagree”), 3 (“some help/some trouble/ FM score of 100 [32]. neitheragree nordisagree”), 2 (“a lot of help/a lot of The assessment is performed in a quiet area when the trouble/moderately agree”), and 1 (“total help/could patient is maximally alert. The motor domain has well- not do it at all/strongly agree”). The domains are established reliability and validity as an indicator of scored separately; a total score is also calculated, with motor impairment severity across different stroke recov- higher scores indicating better function. The SS-QOL ery time points [33, 34]. The clinical value of the FM as- will be assessed at baseline, during the interventional sessment is that it provides a hierarchical scale of motor period (at 4 weeks and 8 weeks), and during the impairment severity; low FM scores indicate greater im- follow-up period (at 12 weeks and 16 weeks). pairment. A higher FM score for the UE or LE is a clin- ical indicator of less motor impairment [35, 36]. The Stroke Syndrome of TCM (SSTCM) minimal clinically important difference (MCID) values The SSTCM was developed mainly based on a quantified [37–39] of the Chinese version of the FMA in motor do- index of TCM symptoms. The SSTCM includes signs main in patients with stroke are 4.58 for UE, 3.31 for and symptoms which cause the most concern for pa- LE, and 6.0 for UE plus LE [40]. We set up a standard- tients and doctors after stroke. SSTCM mainly consists ized procedure for the FM motor assessments, an of two domains: TCM symptoms, and pulse conditions Wang et al. Trials (2017) 18:287 Page 7 of 11 and tongue pictures. The TCM symptoms area contains control to ensure the accuracy of the data. The second 24 items. The assessment standards of each item are level of data integrity will include data monitoring and divided into four levels and corresponding scores validation, which will be conducted on a regular basis (normal = 0, light = 1, middle = 2, heavy = 3), based on throughout the study. The original CRFs and all other the severity of the symptoms and their impact on life. forms (including the consent forms) will be archived se- Pulse conditions and tongue pictures are simply re- curely in the clinical research center of Longhua corded and have no impact on the score. The total score Hospital, affiliated with the Shanghai University of TCM is calculated using only the first domain, with lower for 5 years following publication of the last paper or re- scores indicating a lighter degree of symptom severity port from the study. and a less significant impact on life [43, 44]. Experienced The safety of the study will be monitored by a Data doctors of TCM who accepted the unification of the and Safety Monitoring Board (DSMB) of the clinical assessment training evaluated the SSTCM. The SSTCM evaluation center of Longhua Hospital, affiliated with will be assessed at baseline, during the interventional Shanghai University of TCM, which consists of inde- period (at 4 weeks and 8 weeks), and during the follow- pendent clinical experts and statisticians with access to up period (at 12 weeks and 16 weeks). unblinded data. The DSMB is independent from the sponsor, the competing interests, and the investigational Safety site and will review the performance and safety of the We will conduct the following tests on all participants at trial monthly. the screening stage to exclude patients with serious The criteria for unblinding and discontinuing allo- organic lesions: white blood cells, platelets, hemoglobin, cated interventions for a given trial participant in- alanine aminotransferase/aspartate aminotransferase, clude having a recurrent stroke, having serious gamma-glutamyl transpeptidase, creatinine, and blood complications of stroke or experiencing serious urea nitrogen. acupuncture-related AEs (if any), which have been de- The subjects will be requested to report information scribed previously. The DSMB will reveal a partici- about adverse events (AEs). All AEs that occur during pant’s allocated intervention and make the final the trial period will be recorded, such as sweating, pallor, decision to terminate the trial. dizziness, fainting, perturbed or chest congestion during The final trial data set will be under the custody of acupuncture treatment, local hematoma, bleeding, un- Longhua Hospital/Shanghai University of TCM. The bearable prickling, local anaphylaxis, retained needle data manager from the clinical evaluation center of after treatment, and continuous severe local pain for Longhua Hospital will have access to the complete, an- more than one hour after acupuncture. The researcher onymous final data set. Access to the final data set or will confirm the occurrence of AEs and record all details identifiable data by others will require written requests such as the time of occurrence, date, degree, measure- to be approved by the DSMB of the clinical evaluation ment related to the acupuncture treatment, and causal center of Longhua Hospital/Shanghai University of TCM relationship with the acupuncture treatment. Serious and all study investigators. AEs must be reported to the principal investigator immediately. Sample size calculation The sample size was determined using the results of our Quality control previous clinical trial and pilot trial [45–47]. The pri- Before the trial, all staff members are required to attend mary efficacy parameter is the change in FMA scores a series of training sessions. These sessions will ensure from baseline to the end of treatment after 8 weeks. Ac- that the personnel involved fully understand the research cording to our preliminary test and previous study, the protocol and standard operating procedures for the primary efficacy parameter (FMA score) of the control study. To maintain the clinical trial at a consistently high group (rehabilitation treatment) would be increased by quality, the clinical research center of Longhua Hospital 9.86, and that of the treatment group (scalp acupuncture will monitor the study file, informed consent forms, case combination rehabilitation treatment) would be in- report forms (CRFs), serious AEs, and data records creased by 19.12. The FMA average standard deviation regularly. would be approximately 7.64. A two-sided 5% significance level and 90% power were considered, and the above rele- Data collection, management, and monitoring vant data (9.86, 19.12, 7.64, α =0.05, 1 – β =0.9) were The CRF, Treatment Form, and Adverse Events Form input into NCSS-PASS V11.0.7 software (https:// will be first completed and then double-entered into the www.ncss.com/software/pass/) [48]. On the basis of the electronic data capture (EDC) system electronically by software calculation, approximately 45 participants are re- two independent investigators to act as the first level of quired in each group in order to have a sufficient sample Wang et al. Trials (2017) 18:287 Page 8 of 11 size. With an estimated dropout rate of 20%, each group is medians with ranges, and non-parametric tests will be required to have 54 initial participants. used. Categorical variables will be expressed as number (%) and analyzed by χ test or Fisher’s exact test. De- Participant recruitment scriptive statistics will be used to detail baseline partici- Participants will be recruited from two hospitals pant demographics and general status characteristics of (Longhua Hospital affiliated with the Shanghai University patients, such as gender, age, disease course, hemiplegia of Traditional Chinese Medicine and the Shanghai (left or right), stroke risk factors, and diseased location Changning District Tianshan Traditional Chinese and size. Repeated measures analysis of variance Medicine Hospital, which is a Longhua Hospital (ANOVA) will be used to analyze value changes of branch) in Shanghai, China. Our study will be propa- FMA, MBI, SS-QOL, and SSTCM scores across five test- gated via the Internet, local health-related newspa- ing time points (weeks 0, 4, 8, 12, and 16). Safety ana- pers, and posters in communities and hospitals. lyses will be compared with the incidence of AEs in the Prospective participants will be asked to talk face to two groups using the χ test. face with study coordinators to discuss the study and provide information regarding eligibility criteria. If pa- Discussion tients are eligible and interested in participating, they Chinese scalp acupuncture is a contemporary acupunc- will be invited for a series of rehabilitation assess- ture technique integrating traditional Chinese needling ments after diagnosis by neurologists. One hundred methods with western medical knowledge of representa- and eight patients will be included in the study. tive areas of the cerebral cortex. As acupuncture was de- When their informed consent has been obtained, pa- veloping, various physicians began to introduce western tients will be randomized into two groups with differ- neurophysiology into the field of acupuncture and ex- ent treatments. plored correlations between the brain and human body. Dr. Jiao Shun-fa, who is the founder of Jiao’s scalp acu- Randomization and allocation concealment puncture and a neurosurgeon in Shan Xi Province, is Prior to treatment, each patient will be randomly also the recognized founder of Chinese scalp acupunc- assigned one serial number using a software program. ture. Dr. Jiao combined the modern understanding of Assignments will be sealed in opaque envelopes and will neurophysiology and neuroanatomy with the traditional be opened by the researchers following informed con- concept of acupuncture to develop the new scalp acu- sent procedures and baseline testing. All rehabilitation puncture utilized to affect the functions of the central therapists, assessors, and analysts will be blinded to nervous system. Scalp acupuncture uses special tech- group assignments. niques to harmonize and regulate the functional activ- ities of the brain and body. Many researches on scalp Statistical analysis acupuncture have indicated positive results in treating All data will be analyzed in the clinical research center various disorders of the central nervous system. Stroke of Longhua Hospital, affiliated with the Shanghai is one of the most common diseases for which acupunc- University of TCM by statisticians using the Statistical ture treatment is recommended, according to the WHO Product and Service Solutions (SPSS ) statistical package [49]. In view of the motor dysfunction that occurs post- program (version 17.0, SPSS Inc., Chicago, IL, USA). stroke, the upper one-fifth and middle two-fifths of the Baseline assessments will be conducted before motor area on the scalp were selected as the primary randomization, including gender and age of patients, area for the scalp acupuncture stimulation region. disease course, hemiplegia (left or right), stroke risk In stroke rehabilitation clinical studies, rehabilitation factors, diseased location and size, primary outcome evaluation plays an important role. The FMA and MBI (FMA), and secondary outcomes (MBI, SS-QOL, and were selected as the gold standards for the evaluation of SSTCM). All patients randomized to each group are acupuncture treatment’s curative effect in almost all acu- included in the analysis, and the data analysis will be puncture treatment stroke researches, both domestically conducted using two-sided significance tests at a 5% and overseas. We used the FMA scale to best observe significance level. All analyses will be based on the the comprehensive motor ability of stroke patients based intention-to-treat principle using the last observation on the specific environments and the corresponding in- carried forward rule. Missing values will be handled by structions; the FMA reflects the motor dysfunction level the mixed model for repeated measurements. Continu- of stroke patients and is widely applied in the evaluation ous variables with normal distribution will be expressed of motor dysfunction after stroke [50]. The MBI was as means with standard deviations (SDs) and compared used as an individual-level assessment scale to evaluate by an independent sample Student t test. For abnormally daily life activities of stroke patients; it responds to the distributed variables, the data will be expressed as complex activity ability and necessary functional skills of Wang et al. Trials (2017) 18:287 Page 9 of 11 patients in daily environments and is often used to as- Trial status sess the degree of influence of motor dysfunction in This study has been completed. families and social environments [51]. However, in Chinese medicine, stroke itself is thought to involve sev- Additional file eral interpromoting disease mechanisms, possibly in- cluding qi stagnation, heat, phlegm, blood stasis, and Additional file 1: SPIRIT checklist. (DOC 127 kb) wind. Hence, the common name for stroke in Chinese medicine is wind stroke. According to the “four diagnos- Abbreviations tic methods” of TCM, the syndrome changes in stroke CG: Control group; CRF: Case report form; DSMB: Data and Safety Monitoring Board; EDC: Electronic data capture; FMA: Fugl-Meyer Assessment; LE: Lower patients are in a dynamic development process. These extremities; MBI: Modified Barthel Index; MCID: Minimal clinically important symptoms’ academic terminologies are not relevant to difference; MMSE: Mini-Mental State Examination; NIH: National Institutes of the understanding of western traditional medicine for Health; RCT: Randomized controlled trial; SS-QOL: Stroke-Specific Quality of Life (scale); SSTCM: Stroke Syndrome of Traditional Chinese Medicine; the symptoms of stroke diagnosis, including hemiplegia, TCM: Traditional Chinese medicine; TG: Treatment group; UE: Upper aphasia, and facial nerve paralysis, etc. [52]. Many motor extremities function assessment scales do not accurately reflect the actual curative effect of acupuncture based on syndrome Acknowledgements We would like to thank all patients and doctors who participated in this trial differentiation of TCM in a certain stage of stroke. The for their cooperation. We also would like to express our gratitude to four study of acupuncture treatment of stroke should fully re- graduate students who contributed their time and effort to the preliminary flect and embody the characteristics of TCM [53]. It study (Minghang Yan, Lijun Shi, Yiwen Cai, and Yuhong Ma). needs to develop the evaluation standard of acupunc- ture’s curative effect based on TCM symptomatology. It Funding This article was supported by grants from the Shanghai Municipal Health is not conducive to reasonably judge the effectiveness of and Family Planning Research Center of Traditional Chinese Medicine acupuncture intervention based on the priority of Schools heritage project funding (project number: ZY3-CCCX-1-1007), “syndrome differentiation” because of the lack of an Shanghai Science and Technology Committee key research project funding (project number: 16401970300), and Shanghai Municipal Health and Family appropriate therapeutic effect evaluation standard of Planning Commission of Traditional Chinese Medicine project funding syndromes. However, SSTCM in this research con- (project number: 2014LQ021A). forms to the TCM identification rule of similar syn- dromes and highlights the advantages and characteristics Availability of data and materials Not applicable. of TCM [54, 55]. Acupuncture is a frequently used therapy for stroke Authors’ contributions rehabilitation in China, but the evidence of its effect JW and JP conceived and designed the study, collected the data, and wrote from previous studies seems to be inconclusive [56]. the manuscript. DK revised the manuscript. QHF, XC, and YS analyzed and interpreted the data. MHY, LJS, YWC, and YHM collected the data and Some systematic reviews have been done to study the ef- coordinated recruitment and treatment of patients. All authors read and fect of acupuncture on stroke rehabilitation [14, 25, 57, approved the final manuscript. 58]. These reviews have drawn consistent conclusions that acupuncture appears to be safe and effective for Competing interests The authors declare that they have no competing interests. stroke rehabilitation, but the benefits require further confirmation with larger, more transparent and well- Consent for publication conducted randomized clinical trials. Thus, the purpose Not applicable. of this research is to observe the therapeutic effect of scalp acupuncture using Jiao’s motor area for motor Ethics approval and consent to participate The research protocol has been approved (number 2013LCSY056) by the dysfunction in patients with ischemic stroke according Research Ethical Committee of the Affiliated Longhua Hospital of Shanghai to both international general evaluation scales and TCM University Traditional Chinese Medicine and Shanghai Changning District evaluation systems. Tianshan Hospital of Traditional Chinese Medicine (Longhua Hospital Branch). In the case of any changes to the study protocol, we will submit a written Under strict quality control, this study could poten- application form to the Research Ethics Committee. They will decide tially confirm whether or not scalp acupuncture on a whether or not it is necessary to change the study protocol. The Research motor area is an effective adjunct to the standard re- Ethics Committee will supervise all procedures of the study. The purpose and risks of the trial will be explained in detail to the participants, who will habilitation treatment for stroke patients with motor be required to write informed consent to indicate that they agree with the dysfunction. This study also aims to explore the correl- protocol and would participate in the trial. The participants will be able to ation between the TCM symptoms improved and the quit at any time during the study period. motor function recovery for patients with stroke, which is of great significance in further improving the evalu- Publisher’sNote ation system of acupuncture treatment on motor Springer Nature remains neutral with regard to jurisdictional claims in dysfunction in these patients. published maps and institutional affiliations. Wang et al. Trials (2017) 18:287 Page 10 of 11 Author details 21. Wu HM, Tang JL, Lin XP, et al. 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Journal

TrialsSpringer Journals

Published: Dec 1, 2017

Keywords: medicine/public health, general; biomedicine, general; statistics for life sciences, medicine, health sciences

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