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NCT Number: NCT05930262

Acupuncture Therapy Combined With Breathing Training for Patients With Stroke Complicated

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Lung Diseases Nervous System Diseases Respiratory Tract Diseases Vascular Diseases

Age range

28 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Shijiazhuang, Hebei, 050000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TCM acupuncture therapy

Device

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.

Conventional drug therapy

Drug

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.

Rehabilitation therapy

Behavioral

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.

breathing training

Behavioral

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.

Primary outcomes

  1. Serum inflammatory factors：C-reactive protein (CRP) level

    Time frame: 2 Weeks

    C-reactive protein (CRP) level(mg/L)

  2. Serum inflammatory factors：Calcitonin (PCT) level

    Time frame: 2 Weeks

    Calcitonin (PCT) level(ng/mL)

  3. Serum inflammatory factors：WBC

    Time frame: 2 Weeks

    WBC (x 109/L)

  4. Improvement time for symptoms and signs of pulmonary infection：Time of fever relieving

    Time frame: 2 Weeks

    the time for body temperature to return to normal (d)

  5. Improvement time for symptoms and signs of pulmonary infection：Time for the disappearance of cough

    Time frame: 2 Weeks

    the time for the disappearance of cough (d)

  6. Improvement time for symptoms and signs of pulmonary infection：Time for the disappearance of expectoration

    Time frame: 2 Weeks

    the time for the disappearance of expectoration (d)

  7. Improvement time for symptoms and signs of pulmonary infection：Time for the disappearance of moist rales

    Time frame: 2 Weeks

    the time for the disappearance of moist rales (d)

  8. TCM syndrome score

    Time frame: 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.

  9. Clinical pulmonary infection score (CPIS)

    Time frame: 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.

  10. Pulmonary indexes:forced vital capacity (FVC)

    Time frame: 2 Weeks

    To measure the forced vital capacity (FVC)(L) before and after treatment

  11. Pulmonary indexes:forced expiratory volume in the first second (FEV1)

    Time frame: 2 Weeks

    To measure the forced expiratory volume in the first second (FEV1)(L/S) before and after treatment

  12. Pulmonary indexes: peak expiratory flow (PEF)

    Time frame: 2 Weeks

    To measure the peak expiratory flow (PEF)(L/S) before and after treatment

  13. Efficacy evaluation:Number of patients with clinical efficacy（Cured，Effective，Remarkably effective，Invalid）

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Second Hospital of Hebei Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Jul 5, 2023
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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