The Effect of Acupuncture in COPD Patients With Persistent Dyspnea Despite Medical Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Modified Medical Research Council (mMRC) Dyspnea Scale
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of acupuncture as an adjunctive non-pharmacological therapy in patients with stable COPD who continue to experience dyspnea despite optimal medical treatment.
详细描述
A total of 60 patients diagnosed with COPD will be randomly assigned to either a control group receiving standard pharmacological treatment or an intervention group receiving standard treatment plus acupuncture. The intervention group will undergo 10 acupuncture sessions (twice weekly for 5 weeks) using predefined acupuncture points based on previous COPD studies.
Primary outcomes include changes in dyspnea severity measured by the Modified Medical Research Council (mMRC) Dyspnea Scale, the COPD Assessment Test (CAT), and the Borg scale. Secondary outcomes include changes in pulmonary function (FEV1, FVC, FEV1/FVC) and functional exercise capacity assessed by the 6-Minute Walk Test (6MWT) and Incremental Shuttle Walk Test (ISWT). Spirometry and exercise testing will be performed pre- and post-intervention. The study will help determine whether acupuncture provides statistically and clinically meaningful improvements in symptom burden and exercise tolerance in COPD management.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteers aged between 40 and 80 years, who are communicative and cooperative,
- •Diagnosed with COPD for at least 3 months,
- •Receiving dual or triple regular pharmacological therapy for at least 3 months,
- •Post-bronchodilator FEV1/FVC <70% and predicted FEV1 <80% on spirometry, mMRC (Modified Medical Research Council) dyspnea score of 2 or higher,
- •COPD Assessment Test (CAT) score of 10 or higher.
排除标准
- •Patients who do not consent to participate in the study,
- •Patients with communication difficulties or with visual, walking, or hearing impairments,
- •Patients currently experiencing a COPD exacerbation or with a history of exacerbation within the past month,
- •Patients with Stage 1 COPD (FEV1 ≥ 80%),
- •COPD patients receiving monotherapy,
- •Patients with mMRC score <2 and CAT score <10,
- •Patients with unstable angina, acute myocardial infarction (within 3-5 days), uncontrolled arrhythmia, active endocarditis, acute myocarditis/pericarditis, symptomatic severe aortic stenosis, lower extremity DVT, uncontrolled asthma/COPD, pulmonary edema, oxygen saturation (SpO₂) ≤ 90%, acute respiratory failure, or suspected dissecting aneurysm,
- •Patients receiving long-term oxygen therapy (LTOT),
- •COPD patients who have experienced more than two exacerbations in the past year.
- •Withdrawal Criteria:
- •Patients who are unable to complete acupuncture sessions or follow-up assessments in the control group for any reason,
- •Patients who experience an exacerbation during the study (they will be reassessed one month after recovery and may be re-included if eligible),
- •Patients who miss more than two acupuncture sessions.
研究组 & 干预措施
Standard COPD Pharmacological Treatment Group (Control)
Drug: Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS) Patients receive standard pharmacological treatment for COPD according to current clinical guidelines without acupuncture. This will serve as a control group.
干预措施: Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS) (Drug)
Acupuncture + Standard COPD Pharmacological Treatment Group (Intervention)
Participants in this group will receive standard pharmacological treatment for COPD in addition to acupuncture therapy. - Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS)
Acupuncture will be administered twice weekly for 5 weeks (10 sessions total) at predefined bilateral acupoints: LU1, LU9, LI18, ST36, GB12, BL13, BL20, and BL23. Single-use, sterile 25 mm × 0.25 mm needles will be inserted at each point for 20 minutes per session.
干预措施: Acupuncture (Behavioral)
Acupuncture + Standard COPD Pharmacological Treatment Group (Intervention)
Participants in this group will receive standard pharmacological treatment for COPD in addition to acupuncture therapy. - Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS)
Acupuncture will be administered twice weekly for 5 weeks (10 sessions total) at predefined bilateral acupoints: LU1, LU9, LI18, ST36, GB12, BL13, BL20, and BL23. Single-use, sterile 25 mm × 0.25 mm needles will be inserted at each point for 20 minutes per session.
干预措施: Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS) (Drug)
结局指标
主要结局
Modified Medical Research Council (mMRC) Dyspnea Scale
时间窗: From baseline to the end of treatment at 6 weeks
Change in dyspnea severity measured by the Modified Medical Research Council (mMRC) Dyspnea Scale from baseline to 6 weeks.
次要结局
- COPD Assessment Test (CAT)(From baseline to the end of treatment at 6 weeks)
- Change in Forced Expiratory Volume in 1 Second (FEV1)(From baseline to the end of treatment at 6 weeks)
- 6-Minute Walk Test (6MWT)(From baseline to the end of treatment at 6 weeks)
- Incremental Shuttle Walk Test (ISWT)(From baseline to the end of treatment at 6 weeks)
- Change in Forced Vital Capacity (FVC)(From baseline to the end of treatment at 6 weeks)
- Change in FEV1/FVC Ratio(From baseline to the end of treatment at 6 weeks)
研究者
Bilinç Doğruöz Karatekin
MD, Specialist of PMR,Principal Investigator
Istanbul Medeniyet University