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STUDY PROTOCOL
Asia Pac J Clin Trials Nerv Syst Dis 2017,  2:72

Scalp acupuncture for dyskinesia after ischemic stroke: Study protocol for a parallel randomized controlled clinical trial


Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China

Date of Web Publication28-Apr-2017

Correspondence Address:
Jian Pei
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai
China
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Source of Support: This study was supported by the Key Scientific Research Program of Shanghai Municipal Science and Technology Commission in China, No. 14401971300, 1640197030; the Key Program of Shanghai Municipal Health and Family Planning Commission in China, No. ZY3-CCCX-1-1007, ZJ2016001, 2016LP041; the National Natural Science Foundation of China, No. 81603697., Conflict of Interest: None


DOI: 10.4103/2542-3932.205197

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  Abstract 

Background: Scalp acupuncture formed by combining traditional Chinese acupuncture techniques and modern theories in medical anatomy has been widely used to treat ischemic stroke in China, but effective clinical trials that verify its efficacy are lacking. This study proposes to verify the effects of Lu's scalp acupuncture on ischemic stroke by comparing differential improvement of motor function between conventional rehabilitation alone and conventional rehabilitation with Lu's scalp acupuncture.
Methods/Design: We will conduct a randomized, controlled, parallel, clinical trial. We will collect 116 ischemic stroke patients with dyskinesia from Longhua Hospital, Shanghai University of Traditional Chinese Medicine and Huashan Hospital, Fudan University in China. All patients will be equally randomized into either a control group (conventional rehabilitation) or an experimental group (scalp acupuncture + conventional rehabilitation). In the control group, patients will receive conventional rehabilitation according to the Guidelines for Stroke Rehabilitation in China. In the experimental group, conventional rehabilitation will be supplemented with oblique acupuncture at approximately 30° and an insertion depth of 25–35 mm in the anterior oblique line of vertex-temporal (MS6). Twisting speed will be 200 times per minute. Acupuncture will be performed 30 minutes, once per day. Patients in both groups will receive rehabilitation five times per week for 8 consecutive weeks. The primary outcome will be the difference in Fugl-Meyer assessment motor function score between posttreatment (4 weeks, 8 weeks, and 6 months of follow-up) and baseline. The secondary outcomes will be differences in the Modified Barthel Index, stroke-specific quality of life, and stroke syndrome of traditional Chinese medicine.
Discussion: This trial will provide objective data on the effectiveness of scalp acupuncture in ischemic stroke patients with dyskinesia.
Trial registration: ClinicalTrials.gov identifier: NCT03120650.
Ethics: The study protocol has been approved by the Ethics Committee of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine of China on 23 October 2013, approval number 2013LCSY056.
Informed consent: Written informed consent will be provided by subject guardians.

Keywords: clinical trial; scalp acupuncture; ischemic stroke; dyskinesia; rehabilitation; randomized controlled parallel clinical trial


How to cite this article:
Fu Qh, Wang J, Pei J. Scalp acupuncture for dyskinesia after ischemic stroke: Study protocol for a parallel randomized controlled clinical trial. Asia Pac J Clin Trials Nerv Syst Dis 2017;2:72-9

How to cite this URL:
Fu Qh, Wang J, Pei J. Scalp acupuncture for dyskinesia after ischemic stroke: Study protocol for a parallel randomized controlled clinical trial. Asia Pac J Clin Trials Nerv Syst Dis [serial online] 2017 [cited 2021 Jun 15];2:72-9. Available from: https://www.actnjournal.com/text.asp?2017/2/2/72/205197


  Introduction Top


History and current related studies

In recent years, the incidence of stroke continues to rise as the population of older people increases, diets change, and pressure increases at the workplace (Mozaffarian et al., 2016). Many stroke patients have motor dysfunction in the early stage of stroke (Fu et al., 2012), which directly affects their qualities of life. Clinical studies have demonstrated that rehabilitation can improve motor function in the extremities and decrease the risk of additional stroke (Ivey et al., 2008; Hornby et al., 2016).

Acupuncture plays an important role in the treatment of diseases of the central and peripheral nervous system, and is a mainstream therapy for rehabilitation in China (Yang et al., 2016). Acupuncture can repeatedly stimulate peripheral sensations, and through its effects on the central and peripheral nervous systems, prevent increased paralysis that results from long-period denervation, thereby preventing adverse effects after stroke (Yang et al., 2016).

Scalp acupuncture can regulate/improve brain lesions and peripheral nerve-tissue excitability by directly stimulating specific parts of the head, which promotes the establishment of cerebral collateral circulation, rapidly reduces vasospasms, expands cerebral blood vessels, increases cerebral blood flow, restores blood supply of brain cells around the lesion, saves ischemic tissue around necrotic foci, and restores neuronal function (Guo, 2006). The motor area of the scalp is based on the functional localization of motor areas of the cerebral cortex. Scalp acupuncture formed by combining traditional Chinese acupuncture and modern medicine has been widely used to treat ischemic stroke in China, and has achieved better clinical results compared with acupuncture alone or modern medicine (Li et al., 2005; Zhao and Xu, 2005; Xie et al., 2007). However, effective clinical trials that verify this efficacy are lacking.

Main objective

We aim to verify the effects of scalp acupuncture on ischemic stroke by comparing the differences in the motor function improvement of between scalp acupuncture combined with conventional rehabilitation and conventional rehabilitation alone. This will provide the experimental basis for clinical application of scalp acupuncture.

Distinguishing features from related studies

Most related studies have performed scalp acupuncture at specific acupoints or scalp stimulation with electroacupuncture [Table 1].
Table 1: Clinical studies of scalp acupuncture for treating ischemic stroke

Click here to view



  Methods/Design Top


Study design

This will be a randomized controlled clinical trial at Longhua Hospital, Shanghai University of Traditional Chinese Medicine and, Huashan Hospital, Fudan University, China, where we will recruit ischemic stroke patients with dyskinesia. Patients will be assigned to a conventional rehabilitation (control) group and a scalp acupuncture + conventional rehabilitation (treatment) group (n = 58) after satisfying inclusion and exclusion criteria. The control group will receive conventional rehabilitation according to the Guidelines for Stroke Rehabilitation in China (Cerebrovascular Disease Association and the Neurological Rehabilitation Association of Neurology Branch of the Chinese Medical Association, 2012). The treatment group will receive the same conventional treatment as the controls along with scalp acupuncture. In both groups, patients will receive treatment five times per week for 8 consecutive weeks.

The primary outcome will be the difference between Fugl-Meyer assessment motor function score at posttreatment follow-ups (4 weeks, 8 weeks, and 6 months) and baseline. The secondary outcomes will be differences in the Modified Barthel Index, stroke-specific quality of life, and stroke syndrome of traditional Chinese medicine. The clinical trial flow chart is shown in [Figure 1].
Figure 1: Clinical trial flow chart.
Note: Fugl-Meyer assessment motor function score, Modified Barthel Index, stroke-specific quality of life, and stroke syndrome of traditional Chinese medicine will be conducted at baseline, and 4 weeks, 8 weeks, and 6 months after treatment.


Click here to view


Study participants

Ischemic stroke patients with dyskinesia, who receive rehabilitation treatment at Longhua Hospital, Shanghai University of Traditional Chinese Medicine and Huashan Hospital, Fudan University will be recruited for participation.

Inclusion criteria

Patients who satisfy all of the following criteria will be considered for study inclusion:

  • Meet to criteria for diagnosis and efficacy evaluation of stroke, formulated by The State Administration of Traditional Chinese Medicine Encephalopathy Emergency Cooperative Group in 1996 (trial implementation)
  • Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China in 2014 (Neurology Branch of Chinese Medical Association and Cerebrovascular Disease Association of Neurology Branch of Chinese Medical Association, 2015)
  • Ischemic stroke diagnosed by computed tomography or magnetic resonance imaging (MRI), with the presence of stable vital signs and awareness
  • An age of 40–70 years
  • Onset within 1–6 months
  • Motor dysfunction in the extremities
  • A Mini-Mental State Examination (Pangman et al., 2000) score > 24 points


Exclusion criteria

Patients with one or more of the following conditions will be excluded from this study:

  • Consciousness disorder or severe cognitive impairment
  • Severe Parkinson's disease, heart disease, cancer, epilepsy, or chronic alcoholism
  • Hepatic or renal impairment
  • Hemorrhagic tendency
  • Congenital disability
  • Pregnancy
  • Currently participating in other clinical trials


Withdrawal criteria

Patients will be withdrawn from the trial if one of following conditions occurs:

  • Complications that affect efficacy and safety judgments or onset of diseases that affect the outcome
  • The use of other therapies or drugs to speed up recovery
  • Inability to complete the follow-up


Sample size

According to our experience (Fu et al., 2012) and instances of withdrawal, we will require a minimum of 58 patients per group.

Recruitment

Recruitment information will be posted on the hospital and department bulletin boards. Patients will be able to contact the project leader via their attending physician or by telephone, email, or WeChat. After providing written informed consent, all potential participants will be screened according to the inclusion and exclusion criteria.

Baseline analysis

Baseline data will be collected at enrollment. Precise items are displayed in [Table 2].
Table 2: Patient records

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Randomization

Patients will be divided into control and treatment groups (n = 58 each) with STAT software.

Blinding

Both the investigator and the operator will know the patients' groups and treatments. Only efficacy will be evaluated using a blinded method. Thus, data analysis will be conducted by reviewers who do not participate in the course of treatment or know the group assignments.

Interventions

Conventional rehabilitation (control) group

Rehabilitation plans will be made according to the Guidelines for Stroke Rehabilitation in China (Cerebrovascular Disease Association and the Neurological Rehabilitation Association of Neurology Branch of the Chinese Medical Association, 2012), including physical therapy and occupational therapy.

Rehabilitation will be conducted for 1 hour, five times per week (Monday through Friday) for 8 weeks.

Early physical therapy will include body position in bed, active and passive motion of the knee joint, turning and moving on the bed, lying-sitting-standing-standing balance, and gait training.

Occupational therapy: According to the level of motor dysfunction upon admission, individual rehabilitative training programs will be developed with reference to the motor relearning program for stroke patients, including neck control, postural symmetry (mainly for the bilateral extremities), trunk control, balancing, standing balance, sit-to-stand conversion, shoulder girdle control, shoulder joint control, elbow joint control, wrist joint control, hand and finger function, coordination, speed and spontaneous activities, daily living activities, and self-training of fine hand function.

Scalp acupuncture + conventional rehabilitation (treatment) group

Acupoint selection: Shenting (DU24; on the head, 0.5 cun above the center of the anterior hair line), Baihui (DU20; on the head, 5 cun above the center of the anterior hair line, or the intersection of the two ear tips and the midline of the head), and upper 1/5 and middle 2/5 in the anterior oblique line of vertex-temporal (MS6) from International Standard Scalp Point (upper: 0.5 cm posterior to the midpoint of the front and rear midline; middle 2/5: intersection between the eyebrow line and the leading edge of the temple hairline).

Treatment scheme: After disinfection, a disposable No. 30 1.5-cun stainless steel needle will be used to pierce the scalp quickly at a 30° angle to reach the lower layer of the galea aponeurotica and the resistance reduces, the needle body is parallel to the scalp at an insertion depth of 25–35 mm. Twisting manipulation will be conducted quickly at a speed of approximately 200 times/minute, 1 minute's rotating/5 minutes. The needles will be maintained for 30 minutes. Patients in both groups will receive rehabilitation five times per week for 8 consecutive weeks.

Outcome measures

Primary outcome measure

Posttreatment follow-ups will be at 4 weeks, 8 weeks, and 6 months after treatment. The primary outcome will be the differences between Fugl-Meyer assessment motor function score at the follow ups and at baseline. The Fugl-Meyer assessment scale is the first scale to evaluate the effects of sensorimotor recovery after stroke, and is currently the most widely used scale for evaluating motor function of the extremities. Fugl-Meyer assessment motor function score can effectively assess the degree of dyskinesia at different times during recovery after stroke. The maximum total score is 100 points, comprising 66 points for upper extremity evaluation, and 34 points for lower extremity evaluation (Bohannon and Smith, 1987). Specific scoring criteria are provided in Additional file 1 [Additional file 1].

Secondary outcome measures

Secondary outcome measures will be assessed at the same time as the primary outcome measures (4 weeks, 8 weeks, and 6 months after treatment).

(1) Modified Barthel Index: Modified Barthel Index will be obtained, including stool, urine, dressing, using the toilet, eating, transferring, walking for 45 meters, wearing clothes, going up and down stairs, and bathing. Each item is score on a scale of 1 to 5, where higher scores represent stronger independence (Cai et al., 2007a).

(2) Stroke-specific quality of life (SS-QOL) (Chinese Version): The SS-QOL is a self-rating scale that reflects the quality of life of stroke patients, involves energy, family role, language, activity ability, emotion, personality, self-care, social role, thinking, upper extremity function, vision, and working ability. The SS-QOL contains 49 items, with a maximum score of 5 per item. Higher scores indicate better survival states. The SS-QOL has been clinically proven to have good reliability, validity, and sensitivity, can comprehensively and objectively reflect the quality of life of stroke patients (Cai et al., 2007b).

(3) Stroke syndrome of traditional Chinese medicine (SSTCM): The SSTCM contains symptoms and signs that are most concerning for patients and doctors, primarily TCM symptoms, pulse, and tongue conditions. Lower scores represent mild symptoms and less severe effects on life (Zhang et al., 2011).

The schedule of outcome-measurement assessments is shown in [Table 3].
Table 3: Timing of outcome assessment

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Data management

The clinical trial form will be filled out by clinical researchers to ensure that the data are accurate, complete and timely. The original record will be saved.

All data will be collected and sent to Longhua Hospital where it will be made into a database using SPSS software.

During the clinical trial, the main investigator will review the data to ensure that clinical requirements are met and to check for missing items and unity of weights and units of measure. After the data are collected, the main clinical researcher and inspector will monitor and check the integrity and accuracy of the data.

The data processing statistician will further verify and check the completeness and accuracy of the data. Anonymized trial data will be published at www.figshare.com.

Statistical analysis

Statistical analysis will be performed using SPSS 18.0 software (SPSS, Chicago, IL, USA). The count data will be analyzed with a chi-square test. Measurement data will be expressed as the mean ± SD. Normally distributed data with homogeneous variances will be analyzed by t-test. Non-normally distributed data or data with heterogeneous variances will be analyzed by Mann-Whitney U-test. Ranked data will be analyzed using a Ridit test. A value of P < 0.05 will be considered statistically significant.

Confidentiality

Clinical trial observation forms and informed consent forms will be kept private and confidential. No data will be disclosed to any unauthorized party.


  Trial Status Top


This study is currently recruiting participants.

Preliminary test results: Our team has performed different types of electroacupuncture treatment for stroke, and has achieved good results ([Table 4]).
Table 4: Our previous studies concerning scalp acupuncture for treatment of acute ischemic stroke

Click here to view



  Discussion Top


Significance of this study

Doctor Shou-yan Lu served as the first director of the Department of Acupuncture and Moxibustion at Longhua Hospital, Shanghai University of Traditional Chinese Medicine. Lu's acupuncture therapy is one of the representatives of Shanghai Schools of Traditional Chinese Medicine, and has been recorded by Shanghai Intangible Cultural Heritage List (2009) and National Intangible Cultural Heritage List (2011), making a profound influence in acupuncture field in China. In Lu's clinical experience, Baihui and Shenting were used to protect the brain after stroke. The main difference between scalp acupuncture at motor areas and classic acupuncture on head is that the former is applied to locations based on modern medical theory, the latter is on traditional Chinese medicine. This trial selects Lu's classic scalp acupuncture points and MS6 (i.e., the projection area of the precentral gyrus of the cerebral cortex on the scalp) as stimulation sites. This method has been widely used in the treatment of stroke in China, and it has achieved good results (Li et al., 2005; Zhao and Xu, 2005; Xie et al., 2007). Therefore, we will conduct a randomized parallel clinical trial to verify its efficacy.

Advantages and limitations of this study

Acupuncture has been shown to improve motor function recovery from ischemic stroke, and has been extensively used in clinical settings (Pei et al., 2001). Many randomized controlled clinical trials have been conducted, but the overall level of research still requires improvement. There is a few convincing literatures, and what exists lacks sufficient support from evidence-based medicine (Wu et al., 2006; Liu et al., 2008). In this large-sample parallel randomized controlled trial, the 6-month clinical observation can comprehensively evaluate the exact clinical efficacy of interventions. This is a large-sample parallel randomized controlled trial. The evaluation criteria focus on outcomes that have close relationships with lesions and high practical value, which can further demonstrate the effect of scalp acupuncture and provide powerful evidence for clinical treatment. At present, most studies regarding acupuncture for treating ischemic stroke rarely look at imaging data. At present, growing emphases are laid on the imaging data as more scientific and objective evidence evidences of scalp acupuncture in treating ischemic stroke. Therefore, imaging data can be taken into account in future studies to promote a comprehensive analysis on the effects of scalp acupuncture on ischemic stroke.

Evidence for contribution to future studies

We hope this study can provide evidence for clinical application of scalp acupuncture in ischemic stroke patients with dyskinesia.

Additional file

Additional file 1: Fugl-Meyer assessment scale (PDF 36.0 kb).[29]

 
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Declaration of patient consent
The authors certify that they will obtain all appropriate patient consent forms. In the form the patients will give their consent for their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Conflicts of interest
None declared.
Author contributions
QHF wrote the majority of the manuscript. JW participated in manuscript writing. JP served as project leader and designed this trial. All authors read and approved the final version of this manuscript for publication.
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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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]



 

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