CClinicalTrials.gg
CompletedNCT05930262Updated Jul 5, 2023

Acupuncture Therapy Combined With Breathing Training for Patients With Stroke Complicated

An interventional study of TCM acupuncture therapy and Conventional drug therapy in Stroke and Lung Diseases, sponsored by The Second Hospital of Hebei Medical University. Completed at 1 site in China. Open to participants aged 28 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-07-05.

Sponsored by The Second Hospital of Hebei Medical University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
28 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stroke
  • Lung Diseases

Keywords

  • Acupuncture therapy
  • Respiratory training
  • Seroinflammatory factors
  • Lung function
03

Who can participate

Ages eligible
28 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    the intervention group

    TCM acupuncture therapy Conventional drug therapy Rehabilitation therapy Breathing training

    Device: TCM acupuncture therapy · Drug: Conventional drug therapy · Behavioral: Rehabilitation therapy · Behavioral: Breathing training

  • Active comparator
    the control group

    Conventional drug therapy Rehabilitation therapy Breathing training

    Drug: Conventional drug therapy · Behavioral: Rehabilitation therapy · Behavioral: Breathing training

Interventions

  • DeviceTCM 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.

  • DrugConventional 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.

  • BehavioralRehabilitation 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.

  • BehavioralBreathing 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.

05

What researchers measure

Primary outcomes

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

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

    Time frame: 2 Weeks

  2. Serum inflammatory factors:Calcitonin (PCT) level

    Calcitonin (PCT) level(ng/mL)

    Time frame: 2 Weeks

  3. Serum inflammatory factors:WBC

    WBC (x 109/L)

    Time frame: 2 Weeks

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

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

    Time frame: 2 Weeks

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

    the time for the disappearance of cough (d)

    Time frame: 2 Weeks

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

    the time for the disappearance of expectoration (d)

    Time frame: 2 Weeks

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

    the time for the disappearance of moist rales (d)

    Time frame: 2 Weeks

  8. TCM syndrome score

    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.

    Time frame: 2 Weeks

  9. Clinical pulmonary infection score (CPIS)

    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.

    Time frame: 2 Weeks

  10. Pulmonary indexes:forced vital capacity (FVC)

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

    Time frame: 2 Weeks

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

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

    Time frame: 2 Weeks

  12. Pulmonary indexes: peak expiratory flow (PEF)

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

    Time frame: 2 Weeks

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

    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.

    Time frame: 2 Weeks

06

Study locations

1 site
  • Acupuncture Therapy Combined with Breathing Training for Patients with Stroke Complicated with Pulmonary Infection: A Clinical Study
    Shijiazhuang, Hebei 050000, China
07

Registry details

Key details

Study ID
NCT05930262
Lead sponsor
The Second Hospital of Hebei Medical University
Responsible party
WangHonglian (Principal Investigator, The Second Hospital of Hebei Medical University) — Principal investigator
First posted
Jul 5, 2023
Start date
May 1, 2020
Primary completion
May 31, 2021
Completion
Jun 1, 2023
Last update
Jul 5, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion