Acupuncture for Persistent Dyspnea Despite Medical Treatment in COPD

Istanbul Medeniyet University

Status: Active, not recruiting

Conditions: COPD (Chronic Obstructive Pulmonary Disease); Acupuncture

Treatments: Drug: Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS); Behavioral: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT07058259

MU Acupuncture and COPD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Standard COPD Pharmacological Treatment Group (Control)

Active Comparator group

Description:

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.

Treatment:

Drug: Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS)

Acupuncture + Standard COPD Pharmacological Treatment Group (Intervention)

Experimental group

Description:

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.

Treatment:

Behavioral: Acupuncture

Drug: Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS)