Effectiveness and Safety of Laser Acupuncture on Pulmonary Function Test and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Forced Expiratory Volume in One Second (FEV1%)
研究概览
简要总结
This clinical trial aims to evaluate the effectiveness and safety of laser acupuncture as an adjunct therapy in patients with chronic obstructive pulmonary disease (COPD). The main research questions are:
- Does laser acupuncture, when combined with standard pharmacological treatment, improve lung function (measured by FEV1% and FEV1/FVC ratio) more than sham laser acupuncture after 4 weeks of therapy?
- Does this combination also lead to better quality of life, as assessed by the COPD Assessment Test (CAT) and the St. George's Respiratory Questionnaire (SGRQ), compared to the control group, after 4 and 8 weeks?
- Is there a correlation between lung function (FEV1%) and quality of life scores (CAT and SGRQ)?
- Are there any significant adverse effects caused by laser acupuncture compared to sham treatment?
Participants will:
- Undergo spirometry and complete CAT and SGRQ questionnaires.
- Receive either laser acupuncture or sham laser acupuncture sessions.
- Return for follow-up assessments at 4 and 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Blinding will be applied to participants and outcome assessor. Group allocation will not be disclosed to them to minimize assessment bias
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with stable chronic obstructive pulmonary disease (COPD) based on the Global Initiative for COPD (GOLD).
- •No acute exacerbation in the last 4 weeks.
- •Male or female participants aged 20 to 80 years.
- •Willing to participate in the study until completion and has signed informed consent.
排除标准
- •History of lung surgery as treatment for COPD.
- •Psychiatric or cognitive disorders.
- •Underwent acupuncture within the last 2 weeks.
- •Pregnant or breastfeeding.
- •Presence of wounds or skin disorders at the laser acupuncture site.
- •History of uncontrolled epilepsy.
- •Fever > 38.0°C.
研究组 & 干预措施
Intervention Group
Laser Acupuncture
干预措施: Laser Acupuncture (Device)
Control Group
Sham Laser Acupuncture
干预措施: Sham Laser Acupuncture (Device)
结局指标
主要结局
Forced Expiratory Volume in One Second (FEV1%)
时间窗: Baseline and 4 weeks after intervention
Pulmonary function will be assessed using spirometry to measure the percentage of the predicted FEV1 value.
FEV1/FVC Ratio
时间窗: Baseline and 4 weeks after intervention
Pulmonary function will also be evaluated by calculating the FEV1/FVC ratio through spirometry
COPD Assessment Test (CAT) Score
时间窗: Baseline, 4 weeks, and 8 weeks after intervention
Health status and quality of life will be assessed using the CAT questionnaire, which scores from 0 to 40. Higher scores indicate worse health status.
St. George's Respiratory Questionnaire (SGRQ) Score
时间窗: Baseline, 4 weeks, and 8 weeks after intervention
Quality of life will be assessed using the SGRQ, which includes symptom, activity, and impact domains. Scores range from 0 to 100, with higher scores indicating poorer quality of life.
次要结局
- Correlation Between FEV1% and Quality of Life Scores(Baseline, 4 weeks, and 8 weeks)
- Adverse Events Related to Intervention(Immediately post-intervention until 8 weeks)
研究者
Dwi Lestari Ayuningtyas
Principal Investigator
Indonesia University