Acupuncture Therapy Combined With Breathing Training for Patients With Stroke Complicated
- Conditions
- Lung DiseasesStroke
- Interventions
- Device: TCM acupuncture therapyDrug: Conventional drug therapyBehavioral: Rehabilitation therapyBehavioral: Breathing training
- Registration Number
- NCT05930262
- Lead Sponsor
- The Second Hospital of Hebei Medical University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description the intervention group TCM acupuncture therapy TCM acupuncture therapy Conventional drug therapy Rehabilitation therapy Breathing training the intervention group Conventional drug therapy TCM acupuncture therapy Conventional drug therapy Rehabilitation therapy Breathing training the intervention group Rehabilitation therapy TCM acupuncture therapy Conventional drug therapy Rehabilitation therapy Breathing training the intervention group Breathing training TCM acupuncture therapy Conventional drug therapy Rehabilitation therapy Breathing training the control group Conventional drug therapy Conventional drug therapy Rehabilitation therapy Breathing training the control group Rehabilitation therapy Conventional drug therapy Rehabilitation therapy Breathing training the control group Breathing training Conventional drug therapy Rehabilitation therapy Breathing training
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Acupuncture Therapy Combined with Breathing Training for Patients with Stroke Complicated with Pulmonary Infection: A Clinical Study
🇨🇳Shijiazhuang, Hebei, China