Efficacy of Transcutaneous Electrical Stimulation at Dingchuan (EX-B1) in Hospitalized COPD Patients With Severe Dyspnoea: Patient and Assessor Blinded Randomized Placebo Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Dyspnoea
研究概览
简要总结
Introduction:
Chronic obstructive pulmonary disease (COPD) presents with a gradual reduction and little bitterness reversible airflow causing shortness of breath, chronic cough and sputum abnormal. Patients with COPD often suffer exacerbations of their symptoms, particularly dyspnea, causing hospital admissions. Recent studies have shown that acupuncture stimulation transcutánea (AcuTENS) Dingchuan point (EX-B1) could help reduce dyspnea in patients with COPD.
Objective:
The aim of this study was to evaluate the possible utility of adding to the usual treatment stimulation AcuTENS in COPD patients admitted with severe dyspnea.
Methodology:
Patients who agree to participate will be randomly divided into two groups. The intervention group will receive a daily treatment, during the period of hospitalization, 45 minutes stimulation at acupuncture point AcuTENS Dingchuan (EX-B1), while the control group performed the same procedure with a device TENS simulated. The extent of dyspnea in both groups as well as the number of days of hospitalization and the number of drugs consumed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 45 and 70 years, with a diagnose of COPD according to the GOLD guidelines.
- •Patients with one episode of hospitalization for COPD exacerbation in the past year, but not more than three episodes.
- •Smoking habit history of more than 10 packages-year.
- •Patients able to correctly understand and answer the modified Borg scale.
- •Patiens with an initial degree of dyspnoea with a score of at least 5 in the modified Borg scale.
- •Patients recruited for the study during the first 48 hours of their hospitalization.
- •Patients who accept to participate in the study and sign the informed consent.
排除标准
- •Patients with any contraindication for transcutaneous electrical stimulation (patiens with pacemakers, skin injury in the application area ...).
- •Patiens with any cardiovascular, neurological or psychiatric disease that may affect the perception of dyspnea.
研究组 & 干预措施
AcuTENS
Stimulation using a portable TENS electrostimulation device at Dingchuan point using a biphasic rectangular wave with a frequency of 2Hz and a pulse width of 200 ms. The stimulation will be achieved using the highest intensity tolerated by the patient without pain during 40 minuts.
Once a day during 5 consecutive days.
干预措施: AcuTENS (Device)
Sham AcuTENS
Stimulation using a modified portable TENS electrostimulation device at Dingchuan point with no electrical output, even though the screen will light up and display the same data as in the unmodified device during 40 minuts. Patients in this group will be informed that, due to the frequency of stimulation, it is unlikely that they will feel the electric stimulation.
Once a day during 5 consecutive days.
干预措施: Sham AcuTENS (Device)
结局指标
主要结局
Dyspnoea
时间窗: At baseline, day 1, day 2, day 3 day 4 and day 5 of the study.
Change from baseline using the modified Borg scale
次要结局
- Hospitalization days(Up to 1 months after discharge)
- Quantity of drug administered(Up to 1 months after discharge)
- PaO2(At baseline, day 1, day 2, day 3 day 4 and day 5 of the study. (only if there is a medical indication for it))
- Readmissions(Up to 3 months after discharge)
- Peak expiratory flow(At baseline, day 1, day 2, day 3 day 4 and day 5 of the study.)
- Mortality(Up to 3 months after discharge)
- PaCO2(At baseline, day 1, day 2, day 3 day 4 and day 5 of the study. (only if there is a medical indication for it))
- Arterial blood pH(At baseline, day 1, day 2, day 3 day 4 and day 5 of the study. (only if there is a medical indication for it))
- SaO2(At baseline, day 1, day 2, day 3 day 4 and day 5 of the study. (only if there is a medical indication for it))
- Relapses(Up to 3 months after discharge)