Acupuncture Therapy Combined With Breathing Training for Patients With Stroke Complicated

Sponsor

The Second Hospital of Hebei Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT05930262

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this prospective randomized controlled study is to explore the clinical efficacy of acupuncture therapy combined with breathing training in patients with stroke complicated with pulmonary infection. The intervention group and control group were treated with conventional drug therapy, rehabilitation therapy and breathing training for 2 consecutive weeks. On this basis, the intervention group additionally received acupuncture therapy. To evaluate the clinical efficacy of both groups.

Condition or Disease	Intervention/Treatment	Phase
Stroke Lung Diseases	Device: TCM acupuncture therapy Drug: Conventional drug therapy Behavioral: Rehabilitation therapy Behavioral: Breathing training	N/A

Detailed Description

To explore the clinical efficacy of acupuncture therapy combined with breathing training in patients with stroke complicated with pulmonary infection. Using a prospective randomized controlled study, 72 patients with pulmonary infection after stroke admitted to our hospital from May 2020 to May 2021 were randomly divided into the intervention group and control group, with 36 patients in each group. Both groups were treated with conventional drug therapy, rehabilitation therapy and breathing training for 2 consecutive weeks. On this basis, the intervention group additionally received acupuncture therapy. The traditional Chinese medicine (TCM) syndrome score and clinical pulmonary infection score (CPIS) before and after treatment, time of fever relieving, time for the disappearance of cough, expectoration and moist rales in the lung, white blood cell count (WBC), serum C-reactive protein (CRP) level, calcitonin (PCT) level and pulmonary indexes were compared between the 2 groups, respectively, to evaluate clinical efficacy.

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

Acupuncture Therapy Combined With Breathing Training for Patients With Stroke Complicated With Pulmonary Infection: A Clinical Study

Actual Study Start Date :

May 1, 2020

Actual Primary Completion Date :

May 31, 2021

Actual Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: the intervention group TCM acupuncture therapy Conventional drug therapy Rehabilitation therapy Breathing training	Device: TCM acupuncture therapy TCM acupuncture therapy: Zusanli, Quchi, Hegu, Taichong, Feishu and Fenglong were selected as the main acupoints, and the auxiliary acupoints were selected according to the symptoms, including Fengchi, Dazhui, Lieque, Tiantu, Shenshu, Zhongfu, etc. Drug: Conventional drug therapy Antibiotics were selected based on drug sensitivity test results. Patients with body temperature > 38.5℃ were treated with physical cooling and antipyretic drugs. In patients whose sputum was thick and difficult to cough up, nebulization and inhalation therapy was given, as well as effective coughing and patting the back to expel phlegm were guided. Behavioral: Rehabilitation therapy Comprehensive training for hemiplegic limbs included a joint range of motion training, bridging exercise, turnover training, balance training, gait training, hand function training and self-care ability training, 40 min/d, 6 times/w. Behavioral: Breathing training Training was conducted daily in the morning, or after symptom relief in the case of fever or other discomforts, once a day, 30-40 min/time.
Active Comparator: the control group Conventional drug therapy Rehabilitation therapy Breathing training	Drug: Conventional drug therapy Antibiotics were selected based on drug sensitivity test results. Patients with body temperature > 38.5℃ were treated with physical cooling and antipyretic drugs. In patients whose sputum was thick and difficult to cough up, nebulization and inhalation therapy was given, as well as effective coughing and patting the back to expel phlegm were guided. Behavioral: Rehabilitation therapy Comprehensive training for hemiplegic limbs included a joint range of motion training, bridging exercise, turnover training, balance training, gait training, hand function training and self-care ability training, 40 min/d, 6 times/w. Behavioral: Breathing training Training was conducted daily in the morning, or after symptom relief in the case of fever or other discomforts, once a day, 30-40 min/time.

Arm

Intervention/Treatment

Experimental: the intervention group

TCM acupuncture therapy Conventional drug therapy Rehabilitation therapy Breathing training

Device: TCM acupuncture therapy

TCM acupuncture therapy: Zusanli, Quchi, Hegu, Taichong, Feishu and Fenglong were selected as the main acupoints, and the auxiliary acupoints were selected according to the symptoms, including Fengchi, Dazhui, Lieque, Tiantu, Shenshu, Zhongfu, etc.

Drug: Conventional drug therapy

Antibiotics were selected based on drug sensitivity test results. Patients with body temperature > 38.5℃ were treated with physical cooling and antipyretic drugs. In patients whose sputum was thick and difficult to cough up, nebulization and inhalation therapy was given, as well as effective coughing and patting the back to expel phlegm were guided.

Behavioral: Rehabilitation therapy

Comprehensive training for hemiplegic limbs included a joint range of motion training, bridging exercise, turnover training, balance training, gait training, hand function training and self-care ability training, 40 min/d, 6 times/w.

Behavioral: Breathing training

Training was conducted daily in the morning, or after symptom relief in the case of fever or other discomforts, once a day, 30-40 min/time.

Active Comparator: the control group

Conventional drug therapy Rehabilitation therapy Breathing training

Drug: Conventional drug therapy

Behavioral: Rehabilitation therapy

Behavioral: Breathing training

Training was conducted daily in the morning, or after symptom relief in the case of fever or other discomforts, once a day, 30-40 min/time.

Outcome Measures

Primary Outcome Measures

Serum inflammatory factors：C-reactive protein (CRP) level [2 Weeks]
C-reactive protein (CRP) level(mg/L)
Serum inflammatory factors：Calcitonin (PCT) level [2 Weeks]
Calcitonin (PCT) level(ng/mL)
Serum inflammatory factors：WBC [2 Weeks]
WBC (x 109/L)
Improvement time for symptoms and signs of pulmonary infection：Time of fever relieving [2 Weeks]
the time for body temperature to return to normal (d)
Improvement time for symptoms and signs of pulmonary infection：Time for the disappearance of cough [2 Weeks]
the time for the disappearance of cough (d)
Improvement time for symptoms and signs of pulmonary infection：Time for the disappearance of expectoration [2 Weeks]
the time for the disappearance of expectoration (d)
Improvement time for symptoms and signs of pulmonary infection：Time for the disappearance of moist rales [2 Weeks]
the time for the disappearance of moist rales (d)
TCM syndrome score [2 Weeks]
Before and after treatment, TCM syndrome scores were counted in the two groups. The main and secondary symptoms were classified into 4 levels, with scores of 0, 1, 2 and 3 based on the severity of the symptoms. The tongue coating and pulse pattern were scored into 2 levels, with no scored as 0 and yes as 1. The sum of various scores was calculated as the total score, with a score range of 0-36. The higher the score, the severer the condition.
Clinical pulmonary infection score (CPIS) [2 Weeks]
Before and after treatment, the 2 groups were scored comprehensively based on the average range of 12-h body temperature, WBC range, amount and character of tracheal secretions, index of gas exchange, pulmonary infiltration shadow of X-ray chest film, and pathogenic bacteria in sputum culture. According to the severity, they were divided into 3 levels, with a score of 0, 1 and 2. The maximum score was 12. The higher the score, the severer the infection.
Pulmonary indexes:forced vital capacity (FVC) [2 Weeks]
To measure the forced vital capacity (FVC)(L) before and after treatment
Pulmonary indexes:forced expiratory volume in the first second (FEV1) [2 Weeks]
To measure the forced expiratory volume in the first second (FEV1)(L/S) before and after treatment
Pulmonary indexes: peak expiratory flow (PEF) [2 Weeks]
To measure the peak expiratory flow (PEF)(L/S) before and after treatment
Efficacy evaluation:Number of patients with clinical efficacy（Cured，Effective，Remarkably effective，Invalid） [2 Weeks]
Efficacy was evaluated according to the Criteria of Diagnosis and Therapeutic Effect of Diseases and Symptoms in Traditional Chinese Medicine . Cured: Clinical adverse symptoms such as cough, expectoration and chest tightness disappeared, inflammation was absorbed on X-ray or CT, and routine blood indexes were normal. Remarkably effective: Adverse symptoms such as cough, expectoration and chest tightness were improved significantly, and X-ray or CT and routine blood test results basically returned to normal. Effective: Clinical adverse symptoms such as cough, expectoration and chest tightness were relieved, and X-ray or CT and routine blood test results were improved partially. Invalid: Clinical adverse symptoms such as cough, expectoration and chest tightness had no changes or aggravated.

Eligibility Criteria

Criteria

Ages Eligible for Study:

28 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Meeting the diagnostic criteria of Western medicine for stroke complicated with pneumonia
conforming to the TCM syndrome of vital qi deficiency and phlegm-heat obstructing the lung
confirmed as the initial onset of stroke through CT or magnetic resonance imaging (MRI)
clear consciousness, no cognitive impairment, and ability to cooperate with pulmonary function assessment and rehabilitation training
willingness to participate in this study and sign the informed consent

Exclusion Criteria:

Patients with systemic multi-organ failure such as the heart, brain, kidney, etc
patients with a coronary metal stent or pacemaker implantation
patients with malignant tumors
patients with severe cognitive impairment, depression or mental disorders
patients with pulmonary infections before stroke or caused by other causes
patients in the acute phase of infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Acupuncture Therapy Combined with Breathing Training for Patients with Stroke Complicated with Pulmonary Infection: A Clinical Study	Shijiazhuang	Hebei	China	050000