Tongyuan Acupuncture on Consciousness Disorder After Stroke

NCT ID: NCT06202833

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-20
• Study Completion Date: 2025-12-31

Brief Summary

Stroke is a common and frequently-occurring disease in the world. Patients with stroke often have sequelae and functional disorders of varying degrees, among which the disturbance of consciousness has the greatest impact on prognosis and quality of life.At present, drug therapy, neurosurgical interventional therapy and modern physical therapy are mainly used for post-stroke consciousness disorders. The above therapies to improve the state of consciousness of patients are not supported by sufficient evidence-based evidence, and the other is that they have shortcomings, such as invasive, expensive, and strict indications. Acupuncture has been used in the treatment of sequelae of stroke for thousands of years in China. Tongyuan acupuncture is a set of traditional Chinese medicine therapy pioneered by Professor Lai Xinsheng, a famous doctor of Chinese medicine. A large number of previous studies have proved that Tongyuan acupuncture has a unique effect on the cardiovascular system, gynecology, ent, neurology and other functional disorders. In this study, Tongyuan acupuncture was used in patients with post-stroke consciousness disorder to observe its efficacy and explore the mechanism of action. The purpose of this study is to investigate whether Tongyuan acupuncture can improve the consciousness disorder after stroke, and to provide a new safe, effective, feasible and easy to popularize treatment method.

Detailed Description

This study was a randomized, placebo-controlled, single-blind study. Approximately 174 people will participate in the study at the medical facility. Patients with post-stroke consciousness disorder hospitalized in the Rehabilitation Department of Nanfang Hospital, Guangzhou, China, were randomly included into the experimental group and the control group, and the experimental group was treated with Tongyuan needle acupuncture on the basis of routine rehabilitation therapy and drug therapy. Experimental group selected points: baihui, zhongwan, guanyuan, qihai, tianshu (double).The control group was treated with 1cm acupuncture at the same depth beside the selected points of the experimental group. Before intervention, treatment for 1 week, treatment for 2 weeks, treatment for 3 weeks, and treatment for 4 weeks (after completion), follow-up: Glasgow coma score, Modified Coma Recovery Scale（CRS-R scale） were performed 4 weeks after discharge to assess the conscious state of the patients, and electroencephalogram（EEG）, brainstem evoked potential and Encephalofluctuography were examined before intervention and 4 weeks after treatment. The baseline data of the experimental group and the control group showed no statistical difference through statistical analysis. Conventional rehabilitation treatment and drug treatment were adopted by the current guidelines, and the distribution of cases in the two groups was also random.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Tongyuan acupuncture

Point selection of Tongyuan acupuncture group: baihui, zhongwan, guanyuan, qihai, tianshu (double).The method of lifting, inserting and twisting was used once a day, 5 days a week for 4 consecutive weeks. Twenty days in total. Consciousness levels were assessed before intervention, at 1, 2, 3, and 4 weeks of treatment, and 4 weeks after discharge.

Group Type: EXPERIMENTAL

Acupuncture with regulating immunity as the core of treatment

Intervention Type: DEVICE

The patient was supine, the acupuncture points were disinfected with 75% ethanol, and the acupuncture points on the head and neck were first acupuncture, and then the acupuncture points on the abdomen and limbs. baihui: When the 1.5 inch millimeter needle is needled, the tip of the needle and the acupoint are at a 15-30 ° Angle, and the needle is about 1 inch flat along the subcutaneous area. The twisting speed is about 200 times per minute, and the stitches are once every 15 minutes, and each stitch is about 30 seconds. zhongwan, tianshu: 1.5 inch needle straight puncture 1 inch, small amplitude lifting and twisting. guanyuan, qihai: 1.5 inch millimeter needle downward oblique puncture 1 inch, small amplitude lifting and twisting. The above acupoints were measured by obtaining qi, and the needles were retained for 30min, once a day.5 days a week for 4 weeks.Twenty days in total.

Sham acupoint acupuncture

In the sham-acupoint group, acupuncture treatment was carried out 1cm beside the selected points of the experimental group, once a day, 5 days a week, for 4 consecutive weeks. Twenty days in total. Consciousness levels were assessed before intervention, at 1, 2, 3, and 4 weeks of treatment, and 4 weeks after discharge.

Group Type: SHAM_COMPARATOR

Needles that are not on acupoints

Intervention Type: DEVICE

In this group, acupuncture treatment was performed at 1cm side of the selected points of the Tongyuan acupoint acupuncture group.The piercing Angle is the same as the test group, only piercing, not twisting.Once a day, 5 days a week for 4 weeks.Twenty days in total.

Interventions

Acupuncture with regulating immunity as the core of treatment

The patient was supine, the acupuncture points were disinfected with 75% ethanol, and the acupuncture points on the head and neck were first acupuncture, and then the acupuncture points on the abdomen and limbs. baihui: When the 1.5 inch millimeter needle is needled, the tip of the needle and the acupoint are at a 15-30 ° Angle, and the needle is about 1 inch flat along the subcutaneous area. The twisting speed is about 200 times per minute, and the stitches are once every 15 minutes, and each stitch is about 30 seconds. zhongwan, tianshu: 1.5 inch needle straight puncture 1 inch, small amplitude lifting and twisting. guanyuan, qihai: 1.5 inch millimeter needle downward oblique puncture 1 inch, small amplitude lifting and twisting. The above acupoints were measured by obtaining qi, and the needles were retained for 30min, once a day.5 days a week for 4 weeks.Twenty days in total.

Intervention Type: DEVICE

Needles that are not on acupoints

In this group, acupuncture treatment was performed at 1cm side of the selected points of the Tongyuan acupoint acupuncture group.The piercing Angle is the same as the test group, only piercing, not twisting.Once a day, 5 days a week for 4 weeks.Twenty days in total.

Intervention Type: DEVICE

Other Intervention Names

Tongyuan acupoint acupuncture; Sham acupoint acupuncture

Eligibility Criteria

Inclusion Criteria

1. sign the informed consent voluntarily;

2. met the above diagnostic criteria, and the GCS score was between 3 and 9 (the score was scored by a rehabilitation physician, and the patient had not used sedatives or anesthetics on the day of the score);

3. The patient's condition is stable, vital signs are stable, and the onset time of consciousness disturbance caused by stroke is confirmed to be less than 6 months;

4. Cerebral infarction or cerebral hemorrhage confirmed by clinical and auxiliary examination is the only factor causing consciousness disorder, excluding other diseases caused consciousness disorder patients;

5. those aged between 18 and 85;

6. Family members or authorized principals know and sign informed consent;

7. did not enter other clinical studies at the same time.

Exclusion Criteria

1. People with consciousness impairment mainly due to changes in consciousness content or special types;

2. confirmed carbon monoxide poisoning, brain tumor, brain trauma, brain parasitic disease, metabolic disorders;

3. Patients with severe primary diseases of liver, kidney, blood system, endocrine system and other diseases with poor prognosis, mental diseases;

4. have upper gastrointestinal hemorrhage, secondary epilepsy and other serious complications;

5. Those who have venous thrombosis and are currently on anticoagulant therapy;

6. patients judged by the investigator to be unsuitable for participation in this trial;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

YI WEI

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

YI WEI

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

YI WEI

Role: CONTACT

371328658@qq.com

18588528868

YINGMIN JIAN

Role: CONTACT

718208473@qq.com

13631458025

Facility Contacts

YI WEI

Role: primary

371328658@qq.com

18588528868

YINGMIN JIAN

Role: backup

718208473@qq.com

13631458025

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NFEC-2023-464

Identifier Type: -

Identifier Source: org_study_id