The effect of awn needle deep acupuncture on the hiccup after stroke: a Study Protocol for a Randomized Controlled Trial

doi:10.21203/rs.3.rs-3863649/v1

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Study protocol

The effect of awn needle deep acupuncture on the hiccup after stroke: a Study Protocol for a Randomized Controlled Trial

https://doi.org/10.21203/rs.3.rs-3863649/v1

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Background: Hiccups are common complications after stroke and are characterized by stubborn attacks that seriously affect the patient’s diet and sleep and increase the incidence of aspiration pneumonia. In current research, acupuncture is widely used as a nonpharmacological intervention in many observational studies, but few well-designed randomized controlled trials (RCTs) have been conducted. Therefore, we designed a randomized controlled trial to evaluate the therapeutic effect of awn needle deep acupuncture in the treatment of hiccups after stroke. The RCT could provide a scientific basis for the treatment of hiccups after stroke with awn needle deep acupuncture.

Methods: In this prospective randomized controlled trial, 68 patients with hiccups after stroke who meet the trial criteria will be randomized1:1 intotwo groups: the acupuncture group and the control group. The acupuncture group will be treated with awn needle deep puncture (ANDP) therapy, and the control group will be given metoclopramide intramuscular injection. Both groups of patients will receive the same basic conventional treatment. All treatments will be performed 5 times a week for 2 weeks. The primary criterion is the severity of hiccups, which will be evaluated by the National Institute of Health Stroke Scale (NIHSS) and the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS). The secondary criteria are mental state and sleep score, which will be measured by the Functional Life Index-Emesis (FLIE), Pittsburgh Sleep Quality Index (PSQI) and Mini-Mental State Examination (MMSE). All criteriawill be evaluated at baseline, week 2, week 4, week 8 andweek 12.

Discussion: Our aim was to evaluate the efficacy of ANDP for poststroke hiccups and to assess the effect of two different treatments on patients with poststroke hiccups, thus providing a high-quality rationale for the clinical use of ANDP for hiccups after stroke.

Trial Registration: Chinese Clinical Trial Registry, identifier: ChiCTR2100051110. Registered on 13 September 2021.

hiccup after stroke

awn needle deep acupuncture

randomized controlled trial

protocol

Stroke is the leading cause of death and disability worldwide. Its incidence is on the rise, with high rates of disability, often accompanied by various functional impairments(1–3). The hiccup is one of the most common clinical complications after stroke, which not only seriously affects the patient’s normal diet, sleep and respiratory regulation but also affects the prognosis and recovery of stroke, may aggravate the disease and affect the recovery process of the disease(4).

At present, the clinical treatment of hiccups after stroke is more common. It has been reported that there are a variety of drugs available medically in the treatment of intractable hiccups complicated by stroke, such as metoclopramide(5), promethazine(6), and haloperidol(7). However, medication has many adverse effects and in severe cases can even induce new complications(8). Therefore, there is a need for a safer, more effective treatment with fewer adverse effects to treat hiccups after stroke.

Acupuncture is a core component of traditional Chinese medicine. It can be used to treat many diseases, including osteoarthritis, stroke, gastrointestinal disorders, and cancer pain(9–13). Many researchers have proceeded to a large number of clinical and experimental studies in the treatment of hiccups with acupuncture(14–17). As a type of acupuncture, the awn needle has a slender needle body, which can penetrate directly and deeply to reach the diseased site. It has a good effect of dredging the meridians, regulating the Qi and blood of the human body, and calming the secretion of yin and yang and has the irreplaceable effect of ordinary acupuncture(18). However, there are many ANDP methods and different acupoint choices, and whether they can improve the efficacy of traditional acupuncture therapy in patients with poststroke hiccups remains unclear. To investigate the clinical efficacy and safety of ANDP in hiccups after stroke, we conducted this prospective randomized controlled trial with adequate follow-up. As a preliminary experiment, we aimed to observe the efficacy of ANDP on hiccups after stroke through subjective and objective evaluations and to obtain further data to develop an optimized acupuncture treatment protocol for poststroke hiccups. The results will help to demonstrate whether ANDP is an effective and safe treatment for patients with hiccups after stroke.

Study Design

This prospective randomized controlled trial was supported by the Henan Provincial Health Commission. Subjects for this trial will be recruited from the Rehabilitation Center of the First Affiliated Hospital of Henan University of Chinese Medicine. Sixty-eight patients who meet the predetermined criteria will be selected and randomly divided into 2 groups: the acupuncture group (ANDP group) and the control group (metoclopramide group). All patients will receive treatment 5 times a week for 2 weeks and will be assessed at 4 time points: baseline, week 2, week 4, week 8 and week 12. The primary criterion is the severity of hiccups, which will be evaluated by the NIHSS and the TCMSSS. The secondary criterion will be measured by the FLIE, PSQI and MMSE. Adverse events will also be recorded for safety assessment. The flow chart of the study is shown in Fig. 1.The trial process chart is shown in Table 1.

Table 1

Process chart of the trial
	Study period
Timepoint	Enrollment	Baseline	Treatment phase		Follow-up phase
	1 week	0 week	2 weeks	4 weeks	8 weeks	12 weeks
Enrollment
Eligibility screen	×
Informed consent	×
Medical history	×
Merger disease	×
Randomization		×
Interventions
Treatment group		×	×	×
Control group		×	×	×
Assessments
TCMSSS		×	×	×	×	×
NIHSS		×	×	×	×	×
FLIE		×	×	×	×	×
PSQI		×	×	×	×	×
MMSE		×	×	×	×	×
Adverse events		×	×	×	×	×
Safety evaluation		×	×	×

Recruitment

Multiple strategies will be used to recruit participants. Posters, pictures and videos related to the study will be produced to help participants understand the purpose and procedures of the study and to explain the advantages and disadvantages of the treatment and related safety measures that should be taken during the trial. In addition, we will use websites and hospital-based WeChat advertisements for recruitment. Based on the above inclusion and exclusion criteria, each participant will be initially judged and screened for likelihood of inclusion. Participants who meet the inclusion criteria will be informed of the specifics of the study, and participants or their legal guardians will be needed to sign an informed consent form.

Inclusion, exclusion and elimination criteria

Inclusion Criteria

Participants who meet the following criteria will be included:

Patients with stroke confirmed by CT or MRI.

Patients who meet the diagnostic criteria for hiccups after stroke.

Patients with stable condition and first stroke.

Patients with hiccups more than 10 times/day and hiccups for more than 48 hours.

Patients between 18 and 85 years old.

Patients who are willing to join the study and sign informed consent.

Exclusion Criteria

Participants who meet any of the following criteria will be excluded:

Patients who are irritable and cannot cooperate with acupuncture.

Patients with herniation and coma.

Patients who are unable to complete the prescribed treatment program or use other therapies at the same time may affect the results of this study.

Patients with systemic bleeding disorders.

Patients with severe skin breakage and infectious diseases.

Patients who are pregnant or lactating.

Elimination criteria

Participants who meet the following conditions will be dropped off halfway:

(1) Patients who stopped halfway and no longer received the preset treatment plan;

(2) Patients who develop comorbidities or complications during the course of the trial that require other treatment options; the reasons for dropping cases should be carefully documented, and their relationship to the trial should be described in the final statistical analysis.

Randomization

All patients included in the experiment will be randomized into acupuncture and control groups in a 1:1 ratio. The professional statistician who commissioned this experiment will use SPSS 25.0 software to generate a numerical ordinal table of the randomized groups and identify the participants' groups by their grouping information. This information will be concealed in a sealed opaque envelope labeled with a serial number. The envelope will not be opened until informed consent is obtained. The Clinical Research Center of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine will screen cases in strict accordance with the inclusion and exclusion criteria to identify eligible patients for inclusion and then obtain the random number and grouping information by phone until the total number of patients reaches 68.

Blinding

Due to the limitations of the protocol and the nature of the acupuncture treatment, we are unable to use a double-blind study design; therefore, this protocol is a single-blind design. To maximize the quality of this study, a blinded procedure will be used to assess the results. The assessors will not have access to any participants except for the assessment process. In addition, to minimize the influence of subjective factors of subjects and researchers on the results of the study, the assessment of the results and statistical analyses of this study will be conducted by independent personnel. Statisticians and data managers collecting data and assessing results will be blinded to subgroup information from third-party independent personnel.

Interventions

The enrolled patients were randomly divided into the acupuncture group and the control group, and the corresponding interventions were carried out. The evaluation of efficacy indexes was carried out after two weeks of treatment, and two different intervention methods, ANDP and metoclopramide intramuscular injection, were compared and evaluated before and after treatment. Changes in the frequency and duration of hiccups, symptom scores, incidence of each stage, sleep scores, and mental health scores will be compared before and after treatment, and the effectiveness and cure rates will be calculated. All acupuncturists will be physicians with at least 5 years of experience practicing acupuncture. Additionally, each subject will receive the same basic medication, and neither group will know the treatment assignment. The intervention measures of the two groups are as follows:

Basic medication

According to the actual conditions of all participants in the two groups, the treatment was individualized in accordance with the Chinese Guidelines for the Prevention and Treatment of Cerebrovascular Disease (Bureau of Disease Control of the Ministry of Health, Chinese Medical Association Neurology Branch, 2010). This included comprehensive medical supportive treatment, blood pressure regulation, improvement of cerebral blood circulation (thrombolysis, nephrolization, anticoagulation, antiplatelet aggregation, volume expansion, and traditional Chinese medicine treatment), protection of gastric mucosa, and use of neuroprotective agents.

ANDP group

In addition to the basic conventional treatment, Neiguan (PC6), Yintang (GV29), Fengchi (GB20), Wangu (SI4), Yifeng (TE17), Tiantu (CV22), Zhongwan (CV12), and Zusanli (ST36) were selected. After routine disinfection, 0.30 x 45 mm needles were first used to take the bilateral PC6, twisted and thrusted for 1 minute, and then punctured at GV29, obliquely punctured 0.3–0.5 inches downward along the skin, and subjected to the heavy pecking method until the eyeballs were wet or tearful. Then, a 0.30 x 75 mm needle was used to acupuncture bilaterally (GB20, SI4, and TE17) on both sides. GB20 pierces 2-2.5 inches straight to the corners of both eyes, and the bilateral (SI4 and TE17) puncture is 2-2.5 inches straight. The small amplitude, high-frequency twisting method is applied with both hands for 1 minute. The CV22 point in the middle of the upper sternum fossa was taken, a 0.30 x 75 mm needle was chosen, and the clamping method was used to insert the needle vertically. The needle was inserted for 3–4 minutes, and then the needle was turned downward toward the inner side of the sternum. At the same time, the needle body is naturally bent to approximately 90 degrees to ensure that the direction of the needle tip remains unchanged when the needle is inserted. Insert needle 3 inches and twist out the needle immediately after getting the breath. If the doctor feels pulsation under the needle tip, stop the needle immediately to avoid damaging the arteries and blood vessels and causing accidents. A 0.30 x 75 mm awn needle was used to directly pierce the CV12 acupoint. After routine disinfection, the clamping needle method was used, and the needle was slowly twisted vertically. If the needle resistance is large or the patient is in pain, do not force the needle. When the patient consciously feels that the needle radiates from the chest to the flanks, back and lower abdomen, it means getting Qi. Slowly twist the needle out after getting Qi. The needle should be retained at 0.5 to 2 inches subcutaneously, and the needle should be retained after 1 minute with a flattening and reducing technique. Regardless of whether Qi is present, once the doctor feels an arterial pulsation under the needle, he should stop inserting the needle to avoid damaging the abdominal aorta. A 0.30 x 75 mm awn needle was used to puncture ST36 flat, parallel to the tibia, with the tip pointing to the lateral malleolus, gently twisting and advancing slowly, reaching a depth of 3 inches, and the twisting and easing method was applied to expand the needle sensation around. The needle was retained for 30 minutes, 5 times a week, for a total of 2 weeks of treatment. The specific positions of the acupoints are listed in Tables 2.

Tables 2: Specific acupuncture; therapeutic methods of each acupoint. A 1 inch (~ 20 mm) is defined as the width of the interphalangeal joint of the patient5s thumb.

Acupoints	Location	Insert angle	Insert depth
Neiguan (PC6)	Forearm front area, 2 inch above the transverse striae of the palm of the wrist, between the palmar longus tendon and the flexor carpi radialis.	90°	0.5 ~ 1.5 inch
Fengchi (GB 20)	In the nape, below the occipital bone level with fengfu, the depression between the sternocleidomastoid and the upper end of the trapezius.	90°	2 ~ 2.5 inch
Yintang (GV29)	On the head, at the intersection of the line between the two brows and the front midline	15°	0.3 ~ 0.5 inch
Wangu (SI 4)	In wrist area, in the red and white fleshy depression between the base of the fifth, metacarpal bone and the triangle bone.	90°	2 ~ 2.5 inch
Yifeng (TE17)	In the neck, behind the earlobe, and in the depression in front of the lower end of the mastoid.	90°	2 ~ 2.5 inch
Zhongwan (CV12)	On the anterior median line of the upper abdomen, 4 inch above the navel	90°	0.5 ~ 2 inch
Tiantu (CV22)	In the anterior area of the neck, in the center of the suprasternal fossa, on the anterior midline.	90°	3 inch
Zusanli (ST36)	On the outside of the calf, 3 inches below the calf's nose, at the 1 transverse finger of the front edge of the tibia.	15°	3 inch

This group of acupoints was discovered by clinicians during long-term study and clinical practice of acupuncture and moxibustion. The acupuncture method is based on the principle of "regulating the mind, regulating Qi, and reducing the inverse of the stomach". It not only starts with local lesions but also regulates the function of the brain as a whole. This study provides a certain clinical basis for the promotion of standardized and specific treatment of hiccups after stroke.

Control group

In addition to the basic conventional drug treatment, this group was treated with metoclopramide (National standard number H31021522, Shanghai Qiaofeng Pharmaceutical Co., Ltd. ): 10 mg, intramuscular injection, once every 12 hours, 5 times a week, for a total of 2 weeks.

Outcome assessments

Observation indicators for measurement include baseline, safety indicators (general physical examination, blood routine, urine routine, stool routine, electrocardiogram, liver and kidney function test) and clinical efficacy observation indicators. All assessments will be carried out before and after treatment. The main results will refer to the NIHSS and the TCMSSS, and the secondary results will be scored by the FLIE, PSQI and MMSE. All results will be evaluated at baseline, week 2, week 4, week 8 and week 12 at the end of treatment.

Primary Criterion

Primary outcomes are the TCMSSS and the NIHSS

Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)

The clinical efficacy evaluation standard refers to the "People's Republic of China Traditional Chinese Medicine Industry Standards TCM Disease and Syndrome Diagnosis and Efficacy Standards (ZY/T001. 1–94) issued by the State Administration of Chinese Medicine on June 28, 1994 and implemented on January 1, 1995. The “Guiding Principles for Clinical Research of New Chinese Medicines” are drafted as follows: The frequency of vomiting is used as a scoring standard for scoring, > 10 times/h, 3 points; 5 ~ 10 times/h, 2 points; < 5 times/h, 1 point; and no vomiting, 0 points. Recovery: Symptoms disappeared during 1 course of treatment, and no recurrence was observed; Significantly effective: Symptom score decreased by more than 6 points after 1 course of treatment; Effective: Symptom score decreased by 3 points after 1 course of treatment; Ineffective: At 1 No significant improvement or aggravation after the end of the course of treatment.

National Institute of Health Stroke Scale (NIHSS)

The mental state and sleep scale developed by the NIHSS are scored. A comparison of the improvement of clinical symptoms between the two groups of patients before and after treatment. The scores were scored by observing the changes in the mental state, diet and sleep of the patients before and after treatment. The score sheet was divided into 5 levels, and the changes in the quality of life score of the patients were observed.

Secondary Criterion

Secondary outcomes are mental state and sleep score, which will be measured by the FLIE, PSQI and MMSE.

Nausea and Vomiting Life Function Index Scale (FLIE)

FLIE is used to treat nausea and vomiting within 5 days and is scored as follows: Grade 0: no vomiting within 24 hours; Grade I: 1 ~ 2 vomiting within 24 hours (at least 5 minutes interval); Grade II: vomiting 3 to 5 times within 24 hours (at least 5 minutes apart); Grade III: vomiting 6 or more times within 24 hours (at least 5 minutes apart), requiring tube feeding, intravenous nutrition or hospitalization; and Degree IV: life-threatening, requiring urgent treatment.

Pittsburgh Sleep Quality Index (PSQI)

The scale was developed by Dr. Buysse, a psychiatrist at the University of Pittsburgh, USA, in 1989. It is one of the most validated and widely used sleep disorder assessment scales and is used to assess the sleep quality of subjects in the last month. It is suitable not only for the evaluation of sleep quality in patients with sleep disorders and mental disorders but also for the evaluation of the sleep quality of ordinary people. The scale consists of 9 questions: the first 4 questions are fill-in-the-blank questions, and the last 5 questions are multiple-choice questions. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.

Mini-Mental State Examination (MMSE)

Compiled by Folstein et al. in 1975, the MMSE is one of the most influential standardized mental status examination tools. Scoring: 1 point is correct for 1 point, and 0 points for error. The total score ranges from 0 to 30 points, and the normal and abnormal cutoff value is related to the educational level. The illiterate (uneducated) group has ≤ 17 points, the primary school (education years ≤ 6 points) group has ≤ 20 points, and the middle school or above (education period > 6 points) group has ≤ 24 points. Below the cutoff value is cognitive deficit, and above is normal.

Safety Evaluation and Adverse Events

Throughout the course of treatment, all adverse events and their treatment methods will be recorded. Adverse events related to acupuncture treatment include severe pain, fainting, bleeding or any other discomfort. During the intervention, researchers will pay close attention to the patient's condition. If the patient has any discomfort, the intervention will be stopped immediately, and the patient's condition will be dealt with accordingly. Detailed information on any medical event will be reported in detail in the case report form (CRF). The principal investigator will review all adverse events on a regular basis, and the ethics committee will obtain interim results.

Quality Control

To reduce potential bias and improve the quality of this study as much as possible, we will hire qualified clinical trial experts from the Clinical Research Center of the First Affiliated Hospital of Henan University of Chinese Medicine to monitor this study and to monitor all aspects of data collection and management. Establish the responsibilities of researchers. If problems are found in the project, the center will decide to change the research plan after applying for the approval of the ethics committee. Establish reasonable and feasible data standard operating procedures (SOPs) to ensure the quality of data collection and management at all stages. Data management will be carried out by relevant personnel who have been trained and strictly follow the SOP operation. At the same time, a quality control team will be established to conduct regular quality control and inspections. Qualified clinical trial experts will supervise the work of the clinical trial center at least once a month.

Sample Size

The purpose of this study was to evaluate the effect of ANDP in the treatment of hiccups after stroke. At present, it is reported in the literature that the effective rate of metoclopramide in the treatment of hiccups after stroke is approximately 62.5% (19), and the effective rate of awn needle deep puncture is expected to be 95% (20). The sample size was calculated by using the following:

N = 2(µα + µβ) 2p (1-p)/(p1-p2) 2

N is the needed sample size for each group, and the sample size of each group is equal. When α is 0.05 and β is 0.1, the normal distribution quantile table shows the following: µα = 1.645, µβ = 1.282; in this study, p1 = 0.625, p2 = 0.95, p=(p1 + p2)/2, substituting the formula, then: n = 27.15, that is, the number of samples is approximately 28 cases per group. Therefore, the number of cases in the treatment group and the number of cases in the control group were 34 cases each (including a 20% dropout rate).

Data Collection and Management

All patient data will be recorded on the CRF, including observation time points, outcome measurements, adverse events, and safety assessments. Two independent researchers entered the data into an Excel 2021 spreadsheet, and each patient's personal privacy information was protected. The data will be safely stored by our team's data researchers and supervised by the ethics committee of the First Affiliated Hospital of Henan University of Chinese Medicine.

Statistical Analysis

We will invite third-party professional statisticians who do not know the trial protocol to conduct statistical analysis and participate in the whole process consisting of trial design, implementation and data analysis. If the necessary data are available, subgroup analyses will be performed by different clinicopathological features, such as sex, age, time of stroke onset, and stroke severity. Statistical analysis will be performed using SPSS 25.0.

The data will be statistically described by the mean ± SD. Continuous variables will be compared by the F test or Wilcoxon rank-sum test, and categorical variables will be compared by Pearson's %2 test or Wilcoxon rank-sum test. The comparison between groups will be carried out by independent sample Mest or Mann‒Whitney U rank sum test based on whether the measurement data present a normal distribution and homogeneous variance. When performing statistical analysis with 2-tailed testing, the significance level will be set at 5%. When P < 0.05, differences will be considered statistically significant.

Hiccups after stroke seriously affect the patient's normal diet and sleep, increase the incidence of aspiration pneumonia, and post-rehabilitation treatment(21). It severely limits the recovery of patients' daily life and social life ability and can even induce serious complications, such as pneumonia and deep vein thrombosis(22). Therefore, it is of great significance to find effective treatments to reduce vomiting after stroke. This study aims to evaluate the effectiveness and safety of ANDP in the treatment of hiccups after stroke. It can provide an effective clinical method for patients with hiccups after stroke and provide a scientific basis for the superiority of ANDP in the treatment of hiccups after stroke.

Acupuncture Points Selection

The occurrence of hiccups after stroke is not only due to the upside-down of stomach Qi but is also more closely related to the diseased brain(23–25). In this study, based on the previous stage, ANDP was used to regulate the mind and Qi and relieve the stomach. Not only from the local lesions but also the overall adjustment of brain function, in the selection of acupoints, PC6 and GV29 have the effect of regulating the mind and lowering the nirvana, widening the chest and regulating the diaphragm(26); GB20, SI4, and TE17 points are located at the vertebral-basal artery ring. The vertebral-basal artery system is responsible for 1/3 of the intracranial blood supply. Acupuncture at these 3 points can promote the blood supply of the cerebral arteries and improve the blood flow of the cerebral arteries. Microcirculation has the effects of invigorating the brain, regulating the nerves, soothing the nerves and promoting the orifice(27). Using long needles at CV12 and CV22 points to twist into the needles, flattening, relieving, and twisting techniques to achieve conscious needle sensation radiating from the chest to the two sides, back and lower abdomen.

Outcome Measurements Selection

The curative effect of acupuncture is related to the selection of acupuncture points and acupuncture techniques. Classical medicine records that in acupuncture, the back is like a cake, the abdomen is like a well(28), and deep acupuncture of acupoints on the abdomen is relatively safe. ANDP has unique advantages in the treatment of gastrointestinal diseases. It can not only cure diseases treated by conventional filiform needles but also compensate for the shortcomings of conventional filiform needles. It is especially superior to filiform needles in communicating the external and internal meridians and regulating the Qi and blood of the viscera(29). Therefore, it is proposed that ANDP may improve hiccups caused by brain-gastrointestinal axis dysfunction by regulating gastrointestinal motility by reducing gastric Qi, promoting clearing and turbidity, and regulating Qi. Through systematic and standardized research on the clinical efficacy of ANDP in the treatment of hiccups after stroke, it has been confirmed that ANDP is a safe and effective clinical treatment for improving hiccups after stroke, improving the quality of life and nutritional status of patients, and it plays a vital role in improving basic physical fitness for later rehabilitation.

At present, there are more common clinical treatments for hiccups after stroke. According to clinical reports at home and abroad(30, 31), conventional medication has a variety of drugs to choose from in the treatment of intractable hiccups complicated by stroke and has achieved certain clinical effects. However, various drugs have many serious contraindications and adverse reactions. It is not conducive to medication and later recovery from stroke, and severe cases may even induce new complications. An important limitation of our study is that it is an acupuncture trial. It is impossible to perform a double-blind procedure. To reduce this prejudice, each group of patients will be treated in a different room, and each group of patients will be prohibited from talking. In addition, all acupuncturists participating in this study will be trained uniformly, strictly regulate acupuncture operations, and minimize the interference of bias and subjective factors. To achieve our clinical goals, we will strive to standardize every step of this research. We hope that this trial will provide strong evidence for the treatment of hiccups with acupuncture and moxibustion, with a view to incorporating or updating the corresponding TCM rehabilitation guidelines and further formulating clinical rehabilitation treatment methods suitable for grassroots promotion and application.

Trial Status

The first participant will start in July 2021, and it is expected to complete in August 2024.

Consent

Written informed consent will be obtained from all participants. All personal information about potential and enrolled participants will be confidential.

RCTs: randomized controlled trials

ANDP: awn needle deep puncture

TCMSSS: Traditional Chinese Medicine Syndrome Score Scale

NIHSS: National Institute of Health Stroke Scale

FLIE: Functional Life Index-Emesis

PSQI: Pittsburgh Sleep Quality Index

MMSE: Mini-Mental State Examination

SPSS: social science statistics package

CRF: case report form

SOP: standard operating procedure

Ethical Approval

The study was approved by the Ethics Committee of the First Affiliated Hospital of Henan University of Chinese Medicine (reference no. 2021HL-209-02).

Acknowledgments

We thank all the staff who contributed to our study for their effort and support.

Authors’ Contributions

WBL proposed the concept for this trial and designed the study. CCN and YHZ contributed to the conception, design, and manuscript writing. KQS, KXZ helped search the literature and assisted in the recruitment of patients. WCR participated in the revision and editing of this manuscript. All the authors approved the final version of the manuscript.

Funding

This research was supported by the Key R&D Program of Zhejiang (2023C03003), Health Science and Technology Program of Zhejiang Province (2021PY051) and Henan Province Traditional Chinese Medicine Scientific Research Special Project (2021JDZY070).

Availability of data and materials

The original contributions presented in the study are included in the article/supplementary material, and further inquiries can be directed to the corresponding authors.

Ethics approval and consent to participate

This study was approved by the Ethics Committee of the First Affiliated Hospital of Henan University of Chinese Medicine (reference number: 2021HL-209-02).

Consent for publication

Not application.

Competing interests

The authors declare that they have no conflicts of interest.

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The effect of awn needle deep acupuncture on the hiccup after stroke: a Study Protocol for a Randomized Controlled Trial

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Abstract

Figures

Background

Methods/Design

Study Design

Recruitment

Inclusion, exclusion and elimination criteria

Inclusion Criteria

Exclusion Criteria

Elimination criteria

Randomization

Blinding

Interventions

Basic medication

ANDP group

Control group

Outcome assessments

Primary Criterion

Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)

National Institute of Health Stroke Scale (NIHSS)

Secondary Criterion

Nausea and Vomiting Life Function Index Scale (FLIE)

Pittsburgh Sleep Quality Index (PSQI)

Mini-Mental State Examination (MMSE)

Safety Evaluation and Adverse Events

Quality Control

Sample Size

Data Collection and Management

Statistical Analysis

Discussion

Acupuncture Points Selection

Outcome Measurements Selection

Abbreviations

Declarations

References

Additional Declarations

Supplementary Files

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