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 Table of Contents  
STUDY PROTOCOL
Year : 2016  |  Volume : 1  |  Issue : 3  |  Page : 98-106

Scalp acupuncture twisting manipulation for treatment of hemiplegia after acute ischemic stroke in patients: study protocol for a randomized, parallel, controlled, single-blind trial


1 Gansu University of Chinese Medicine, Lanzhou, Gansu Province, China
2 Second Hospital of Lanzhou University, Lanzhou, Gansu Province, China

Date of Web Publication29-Jul-2016

Correspondence Address:
Jin-hai Wang
Second Hospital of Lanzhou University, Lanzhou, Gansu Province
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2468-5577.187075

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  Abstract 

Background: Acupuncture can be used in clinical practice to promote motor recovery in patients with acute ischemic stroke and paralysis. It is an economical, safe, and effective method that can be easily implemented in clinical settings. However, although scalp acupuncture is an easy-to-perform micro-needle therapy, its efficacy in the treatment of hemiplegia resulting from acute ischemic stroke remains disputed.
Methods/Design: This is a randomized parallel-controlled single-blind trial. It will be performed at the Department of Neurology, Second Hospital, Lanzhou University, China. Seventy-two patients suffering from acute ischemic stroke with paralysis will be randomly assigned to undergo 14 days of either conventional drug treatment (control group) or conventional drug treatment combined with scalp acupuncture that uses the twirling-needle method (once a day, 6 consecutive days followed by 1 day off per week). The primary outcome is the difference in National Institutes of Health Stroke Scale (NIHSS) scores between just after the stroke and 14 days after treatment. Secondary outcomes include motor recovery (assessed by the Fugl-Meyer Motor Scale) and activities of daily living (assessed by the Barthel index).
Discussion: Objectively evaluating the efficacy of twirling-needle scalp acupuncture in the treatment of hemiplegia after acute ischemic stroke will provide evidence for assessing whether this method can improve motor recovery from hemiplegia resulting from acute ischemic stroke.
Trial registration: This trial has been registered on 11 March 2016 in the Chinese Clinical Trial Registry (registration number: ChiCTR-IOR-16008083).
Ethics: This trial has been approved by Ethics Committee, Second Hospital, Lanzhou University of China (approval number: 2016A-003) and will be performed in accordance with the Declaration of Helsinki, formulated by the World Medical Association.
Informed consent: Written informed consent will be obtained from the patients and their relatives.

Keywords: clinical trial; scalp acupuncture; twisting manipulation; acute ischemic stroke; hemiplegia; randomized, controlled trial


How to cite this article:
Tian L, Du Xz, Wang Jh, Zhang Zc, Yan Q, Wang L, Sun Rj, Yuan B, Li Xl, Zhang Tz. Scalp acupuncture twisting manipulation for treatment of hemiplegia after acute ischemic stroke in patients: study protocol for a randomized, parallel, controlled, single-blind trial. Asia Pac J Clin Trials Nerv Syst Dis 2016;1:98-106

How to cite this URL:
Tian L, Du Xz, Wang Jh, Zhang Zc, Yan Q, Wang L, Sun Rj, Yuan B, Li Xl, Zhang Tz. Scalp acupuncture twisting manipulation for treatment of hemiplegia after acute ischemic stroke in patients: study protocol for a randomized, parallel, controlled, single-blind trial. Asia Pac J Clin Trials Nerv Syst Dis [serial online] 2016 [cited 2018 Dec 16];1:98-106. Available from: http://www.actnjournal.com/text.asp?2016/1/3/98/187075


  Introduction Top


Ischemic stroke refers to brain injury caused by reduced or interrupted cerebral arterial blood flow. Its causes are variable and its annual incidence rate is about 1/1,000 people (Wang et al., 2003). In stroke patients, ischemia leads to a cascade of injuries, including the release of excitatory amino acids, peri-infarct depolarization, inflammation, and programmed cell death (Liao and Dimagl, 1998). Collectively, these lead to poor muscle coordination and abnormal muscular tension of the affected limb, ultimately causing motor dysfunction. Approximately 80% of patients have various degrees of sequelae; the most common being hemiplegia, which directly influences motor function (Fang, 2004). Therefore, an area of interest in this research field is pursuing how to reduce post-stroke neurological deficits and recover limb motor function.

In principle, stroke treatment includes: (1) Thrombolysis-induced reperfusion within a ultra-early treatment time window. (2) Improving and recovering the blood supply in the ischemic penumbra and promoting microcirculation. (3) Decreasing intracranial pressure through dehydration and preventing/controlling cerebral edema. (4) Actively protecting nerve cells and other brain cells. (5) Monitoring and controlling blood pressure, regulating blood glucose and blood lipid levels, and preventing and treating complications. (6) Performing comprehensive therapy using free radical scavengers, calcium ion channel blockers, and neurotrophic drugs. (7) Actively eliminating risk factors and performing secondary prevention. (8) Performing systematic and standardized rehabilitation treatment as early as possible (Jain et al., 2009; Ansara et al., 2010; Ciccone et al., 2013; Kidwell et al., 2013; Goyal et al., 2015). Modern comprehensive rehabilitation therapy is a widely accepted, effective treatment method for post-stroke hemiplegia that can reduce the rate of disability (Fieschi, 1998; Dromerick et al., 2000; Sholomov et al., 2010; Hu et al., 2014).

As one such comprehensive method, acupuncture is an economical and safe, non-drug therapy that can be used under multiple conditions. Clinical studies have demonstrated that acupuncture can largely improve limb disturbance, promote motor recovery, relieve vasospasm, improve the oxygen supply in the cortical area, and reduce morbidity and mortality in patients with ischemic stroke (Tan and Li, 2004; Chen et al., 2007; Pang and Wang, 2007; Zhang et al., 2011, 2013; Pan et al., 2015; Qiao, 2015; Wang et al., 2015b). Scalp acupuncture is a microneedle therapy developed from traditional acupuncture, modern anatomy practices, and neurophysiology, and is easily administered with little possibility of inducing muscular spasm (Xing et al., 2015). Strong evidence indicates that after scalp acupuncture for ischemic stroke, blood supply in the brain is recovered, blood viscosity is greatly decreased, microcirculation and metabolism are improved, immunologic injury deceases, neuronal apoptosis and inflammation are greatly inhibited, and conduction from the central nervous system toward the periphery is enhanced (Li et al., 1998; Zhang et al., 2007; Xiao et al., 2008; Wu, 2010; Yu et al., 2011; Zhou et al., 2013; Du et al., 2015a). While all these factors promote neuronal injury recovery, reports that scalp acupuncture cannot improve the neurological deficits of patients with ischemic stroke also exist (Hsing et al., 2012; Wong, 2013). The curative effects of scalp acupuncture in treating ischemic stroke are affected by acupoint selection, acupuncture manipulation, timing of intervention, and intervention period (Min et al., 2008). However, there are no uniform standards for these influential factors, which could lead to these contradictory conclusions.

Although numerous studies have investigated the recovery of ischemic stroke after acupuncture treatment, there are few reports on scalp acupuncture for treatment of acute ischemic stroke, perhaps because this treatment is difficult and includes several problems such as non-simple acupoint selection, ad libitum needle specifications, diverse ways to manipulate needles, and non-quantitative acupuncture intensity and duration. This large variation and lack of standards lead to great differences in clinical curative effects. The objective of this trial is to evaluate the effects of twisting-needle scalp acupuncture on the recovery of neurological deficits in the affected limbs of patients with hemiplegia caused by acute ischemic stroke.


  Methods/Design Top


Study design

A prospective, randomized, controlled, single-blind trial.

Study setting

This trial will be performed at the Department of Neurology, Second Hospital, Lanzhou University, China.

Study procedures

We will treat patients with hemiplegia caused by acute ischemic stroke with twisting-needle scalp acupuncture. Seventy-two eligible patients will be randomly assigned to undergo 14 days of either conventional drug treatment (control group) or conventional drug treatment combined with twisting-needle scalp acupuncture (once per day, 6 consecutive days followed by 1 day off for 2 weeks). Before treatments (immediately after stroke) and 14 days after treatment, treatment efficacy will be evaluated using National Institutes of Health Stroke Scale (NIHSS) scores, Fugl-Meyer Motor Scale scores and the Barthel index. The protocol flow chart is shown in [Figure 1].
Figure 1: Flow chart of the trial.
Note: NIHSS: National Institutes of Health Stroke Scale.


Click here to view


Study participants

Patients with hemiplegia caused by acute ischemic stroke will be recruited from wards of the Department of Neurology, Second Hospital, Lanzhou University, China.

Inclusion criteria

Patients presenting with all of the following criteria will be considered for admission.

  • Age: 40-75 years, of either sex
  • Atherosclerotic thrombotic cerebral infarction, cerebral embolism, or cerebral lacunar infarction, with symptoms corresponding to those stated in the diagnostic criteria of cerebrovascular diseases formulated at the Fourth National Conference on Cerebrovascular Diseases in China (Chinese Society of Neuroscience and Chinese Neurosurgical Society, 1996)
  • Symptoms corresponding to Criteria for the diagnosis and treatment of stroke (trial version) (the State Administration of Traditional Chinese Medicine Encephalopathy Emergency Cooperative Group, 1996)
  • Cerebral infarction in the internal carotid artery, confirmed by head MRI
  • First attack of stroke and within 7 days of the event
  • NIHSS score of ≤ 6
  • Patients are conscious and vital signs are stable
  • Patients and relatives provide written informed consent


Exclusion criteria

Patients presenting with any of the following conditions will be excluded from the trial.

  • Attack of cerebral infarction in the bilateral internal carotid artery as confirmed by head MRI, but bilateral limbs show different degrees of hemiplegia
  • Transient cerebral ischemia and irreversible neurological deficits
  • Pregnant or lactating women
  • Severe primary diseases or life-threatening diseases in the heart, liver, kidney, hematopoietic system, or endocrine system
  • Severe mental disorders, such as depression, schizophrenia, or epilepsy


Withdrawal criteria

Patients who meet any of the following conditions will be withdrawn from the trial:

  • Patients who do not meet inclusion criteria but conform to exclusion criteria, who were erroneously recruited
  • Patients who do not receive treatment according to therapeutic regimen or cannot provide full information
  • Patients who cannot participate in the trial because of severe adverse events
  • Patients who require emergency measures to be taken because of complications or a worsened pathological condition
  • Poor patient compliance: number of treatments is less than 80% of the number of required treatments, or they receive other treatment


Sample size

The primary outcome of this trial is the difference in NIHSS scores before and after 14 days of treatment. According to previous studies (Chang et al., 2011; Hu and Chen, 2012; Tang et al., 2012; Hu and Peng, 2013; Wang and Hua, 2014; Wang et al., 2015a), the difference of NIHSS scores is conservatively estimated to be approximately 3 in the control group and 4 in the experimental group, with standard deviation (σ) of 5.

Considering a bilateral α of 0.05 and a β of 0.9, the necessary minimum sample size (n) is calculated as 131 (n = 2(z a/2 + z β ) 2 σ 22 , based on table checking: z a/2 = 1.96, z β = 1.282, Δ = |5 − 3| = 2). In the formula, z is the critical value, α indicates significance level, Δ is the difference in National Institutes of Health Stroke Scale (NIHSS) scores between just after the stroke and 14 days after treatment.

The expected loss rate of the trial is 20%, thus a sample size of 158 per group should be used. As financial support and study time are limited, we must limit the sample size to 72 patients (36 patients per group). Sample size calculation will be performed in accordance with the intention-to-treat principle.

Recruitment

Eligible patients will be referred to the physicians from the department of neurology. After providing written informed consent, all potential participants will be screened according to the inclusion and exclusion criteria stated above.

Randomization

Eighty random numbers (approximately 1.1 times the sample size) will be generated using the RAND function in Microsoft Excel, multiplied by 2, and then converted to integers with the INT function. This will create approximately 80 random numbers equal to 0 or 1. Each patient who meet the inclusion criteria will be assigned the next number on the list. Those receiving a 1 will be included in the experimental group and those with number belonging to 0 will be in the control group. Acupuncture treatment, evaluation, and statistics will be performed by specially-designated persons. The randomization procedure will be only undisclosed to the clinical curative-effect evaluator and data statisticians. The statistical results will be disclosed to the researchers. If severe adverse reactions occur, emergency unblinding will be performed by the researchers when necessary. The reason and data of emergency unblinding will be recorded in the medical case notes. Patients will be randomly assigned to an experimental group or a control group (n = 36 per group).

Interventions

Control group: According to Chinese guidelines of diagnosis and treatment for acute ischemic stroke 2010 (Guidelines Writing Group of Diagnosis and Treatment for Acute Ischemic Stroke of Cerebrovascular Disease Group of Neurologic Branch of Chinese Medical Association, 2010), patients in the control group will receive 14 days of conventional drug treatment.

(1) Oxygen inhalation and respiratory support, heart monitoring, body temperature control; (2) blood pressure control: individualized treatment used to stabilize blood pressure lower than 140/90 mmHg; (3) blood glucose control: use of proper blood glucose-lowering drugs to keep blood glucose level within the normal range; (4) blood lipid regulation: oral use of atorvastatin 10 mg per day according to serum levels of triglycerides and cholesterol; (5) anti-platelet aggregation: oral use of aspirin 0.1 g, once per day; (6) neurotrophy: intravenous administration of ganglioside 40 mg, once per day; (7) free radical scavenger: intravenous administration of edaravone 30 mg, once per day; (8) microcirculation improvement: intravenous administration of Shuxuetong 6 mL, once per day; (9) symptomatic treatment, prevention against complications, and providing nutritional support.

Experimental group: In addition to conventional drug treatment, patients in the experimental group will also receive twisting-needle scalp acupuncture, once per day, 6 consecutive days followed by 1 day off for 2 weeks. The precise acupuncture procedure will be performed as follows according to Du et al. (2015a). Disposable stainless steel acupuncture needles (φ 0.25 × 40 mm; Huatuo brand, Suzhou Medical Appliance Factory, Suzhou, Jiangsu Province, China) will be used. After routine skin disinfection with 75% ethanol, the anterior oblique line of the vertex-temporal lobe (from Qianshencong (EX-HN) to Xuanli (GB6) will be acupunctured bilaterally. The acupuncture needles will be inserted quickly, rotated quickly at small amplitudes using the reinforcing-reducing manipulation method. The needle will be inserted obliquely, forming a 15° angle with the skin surface while puncturing. The needle will be quickly inserted into the lower layer of the epicranial aponeurosis and then gently and rapidly inserted until a depth of 30 mm without twisting. The anterior oblique line of the vertex-temporal lobe on each side will be equally divided into five sections, and three acupuncture needles will be inserted on each side, one in the upper 1/5 th , one in the middle 2/5 th , and one lower 2/5 th . Each needle will be twisted at 200 r/min for 1 minute, once every 9 minutes, making patients feel the needling during acupuncture (i.e., soreness, numbness, tingling or heaviness). Each procedure will be performed three times, thus totally 30 minutes of acupuncture. When the last session is completed, the acupuncture needle will be withdrawn without twirling.

Outcome measures

According to the stroke staging criteria provided by Huang and Guo (2001), the first month after a stroke is considered the acute phase. Therefore, we will evaluate the therapeutic effects of treatment at two time points, before treatment (just after the stroke) and after 14 days of treatment.

Primary outcomes

The difference in NIHSS scores before and after 14 days of treatment is the primary outcome of this trial. The NIHSS score is a 0-42 scale, with higher scores indicative of more severe neurological deficits. It is the most common scale used for evaluating the degree of neurological deficits (Brott et al., 1989; Goldstein and Samsa, 1997; Adams et al., 1999; Dong et al., 2000; Meyer et al., 2007; Cai et al., 2008; Kwakkel et al., 2010), and has been widely used for assessing degree of neurological deficit and for predicting the prognosis of patients with stroke (Brott et al., 1989; Adams et al., 1999; Kwakkel et al., 2010). In particular, it has been used for patients suffering from cerebral infarction (Dong et al., 2000) because of its good reliability, validity, and sensitivity (Goldstein and Samsa, 1997; Meyer et al., 2007; Cai et al., 2008).

Secondary outcomes

Fugl-Meyer Motor Scale scores: The Fugl-Meyer motor scale is the earliest scale used to quantify post-stroke motor recovery. It is an internationally accepted scale that has been widely used to evaluate motor function of the affected limb with high validity and reliability (Nie et al., 2009). We will use the following categorization when comparing scores before and after treatment: (1) almost fully healed: scale score increased by 100%, normal motor performance; (2) greatly improved: score increased by 92-98%, mild motor dysfunction; (3) improved: score increased by 10-91%, moderate to severe motor dysfunction; (4) no change: score increased by up to 9%, severe motor dysfunction; (5) worsened: score decreased up to 10%, severe motor dysfunction (Yun, 2005).

Barthel index: The Barthel index is the internationally accepted and most widely used scale for evaluating patient activities of daily living. It provides good reliability and validity, and can reflect pathological changes and predict stroke prognosis. Activities of daily living = (Barthel index after treatment − Barthel index before treatment)/Barthel index before treatment × 100%. We will use the following categorization of motor function when comparing scores before and after treatment: (1) highly improved: scores increased by 20% or more; (2) improved: scores increased between 12% and 19%; (3) not improved: scores increased less than 12%; (4) worsened: scores decreased (Nan, 2001).

Baseline information for the patients and timing of the trial protocol are shown in [Table 1] and [Table 2], respectively.
Table 1: Baseline patient data

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Table 2: Timing of the trial protocol

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Safety assessments

Routine blood tests, urine tests, stool tests, liver function test, renal function test, and electrocardiogram will be performed before and after treatment. If severe adverse reactions occur during treatment, such as fainting during acupuncture, vascular and nerve injury, or post-needling sensations, treatment will be immediately terminated and appropriate measures will be taken. (1) Fainting during acupuncture treatment: treatment will be immediately terminated, the patient will be asked to lie in the supine position with head kept down, cloth belt loosened, and body kept warm. We will give the patient 300-500 mL of warm boiled water with sugar or not; (2) vascular and nerve injury: the acupuncture needle will be withdrawn immediately. If symptoms are mild, we will resume treatment after a short rest. For severe symptoms, a timely rescue is necessary with the help of specialized physicians, such as a neurosurgeon. If some bleeding occurs as a result of vascular injury, the bleeding point will be pressed for a long period of time and slightly massaged. If substantial bleeding occurs and causes intense local swelling and pain that influence motor function, we will provide cold compress hemostasis followed by a warm compress to promote local blood absorption and dissipation.

Data collection, management, analysis, and open access

Data collection


Data will be accurately collected in a timely fashion and input into case-report forms. The original records will be preserved. A research associate will recheck the data and send them to the data management unit. To ensure data accuracy, the collected data will be input into an electronic database using the double-data entry strategy by professional staff. Patients will be contacted as much as possible in follow-ups to complete all the evaluations. The trial results form will be filled out, and the time at which medication is given will be recorded as possible. If patients drop out of the trial because of adverse reactions related to trial drugs, notes will be recorded in the medical case notes and reported to the sponsors. Data that is lost, logically contrary, mistaken, or unconfirmed will be questioned and notes recorded in the data management form by the data manager. The completed data management form will be delivered to the researchers for recheck and answers to outstanding questions. The database will be rechecked and altered by the data manager according to researcher's answers. The data will be questioned again if necessary.

Data management

After blind review and database confirmation, the database will be locked by the researcher in charge, sponsor, and statistician. The locked database will not be altered and will be preserved by Gansu University of Traditional Chinese Medicine, China. Gansu University of Traditional Chinese Medicine and Second Hospital of Lanzhou University will be the legal holders of the final database.

Data analysis

The database will be disclosed to a statistician for statistical analysis. Results of the statistical analyses will be given in a report provided by the statistician, and a researcher will use these results to write the research report. The whole trial procedure will be monitored by a data monitoring committee to ensure a scientific and rigorous research process and real and complete data recording.

Data open access

All trial data will be published on http://www.figshare.com.

Statistical analysis

All data will be processed by statisticians using SPSS 19.0 software. Intention-to-treat analysis will be performed. Normally distributed measurement data will be expressed as the mean ± SD, and between-group and within-group comparisons of NIHSS scores and Barthel indices will be conducted using independent two-sample t-tests and paired t-tests, respectively. Non-normally distributed measurement data will be expressed as median (interquartile range) [M (IQR)]. In this case, between-group and within-group comparisons will be conducted using the Mann-Whitney U test and the Mann-Whitney-Wilcoxon test, respectively. The chi-square test will be used to test for different constituent ratios (curative effects on neurological deficits, Fugl-Meyer motor scale score, and activities of daily living). The Mann-Whitney U test will be used for between-group comparisons of total effective rate. P < 0.05 will be considered statistically significant.

Auditing

Trial progression will be reported to the ethical committee every half year or once per year, and progress will be updated in the registered database at the same time.

Confidentiality

Any data provided by the sponsor, including trial execution, protocol, design, results, data, medical case notes and informed consent, will be preserved in a locked, secured place and will not be disclosed to any unauthorized party.


  Discussion Top


Most previous studies regarding scalp acupuncture used for treatment of hemiplegia after acute ischemic stroke focus on cellular and biochemical changes (Li et al., 1998; Zhang et al., 2007; Xiao et al., 2008; Wu, 2010; Yu et al., 2011; Zhou et al., 2013; Du et al., 2015a; Wang et al., 2016). Our team previously used subjective scales to evaluate the rehabilitative effects of scalp acupuncture (using the twisting and reinforcing-reducing needle manipulation) on neurological deficits in affected limbs of hemiplegia patients with acute ischemic stroke ([Table 3]).
Table 3: Previous studies on scalp acupuncture for treatment of acute ischemic stroke from LT's team

Click here to view


In this study, we will perform a standardized clinical trial protocol still using NIHSS score, Fugl-Meyer motor scale score, and Barthel index as evaluation indices. This study has several limitations: The sample size is small, study time is short, and the outcome measures do not include molecular, electrophysiological, or behavioral indices, which should be evaluated to reveal the mechanism by which scalp acupuncture can be used to treat hemiplegia after acute ischemic stroke. All of these points will be addressed in future studies to provide more clinical evidence.

Trial status

Recruitment of participants is ongoing at the time of submission.[55]

 
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Conflicts of interest
None declared.
Author contributions
LT, XZD and JHW provide and integrate the data, write the manuscript and authorize the manuscript. XZD, JHW, LT and ZCZ conceive and design this trial. QY and LW perform data analysis. XZD is responsible for fundraising, provides assistance in technique or material use. RJS, BY, XLL and TZZ conduct acupunctures. All authors approve the final version of this manuscript.
Acknowledgments
We are grateful to all teachers and students from Department of Neurology, Second Hospital, Lanzhou University, China for their help and support during the recruitment of participants.
Plagiarism check
This paper was screened twice using CrossCheck to verify originality before publication.
Peer review
This paper was double-blinded and stringently reviewed by international expert reviewers.


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