Acupuncture for Persistent Dyspnea Despite Medical Treatment in COPD

NCT ID: NCT07058259

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2026-01-15

Brief Summary

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.

Detailed 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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Acupuncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

Patients in this group receive standard pharmacological treatment for COPD according to current clinical guidelines. Treatment includes either dual or triple inhaler therapy:

Dual Therapy (LABA + LAMA): Patients receive a long-acting beta-agonist (LABA) such as Formoterol, Salmeterol, Olodaterol, Vilanterol, or Indacaterol, in combination with a long-acting muscarinic antagonist (LAMA) such as Tiotropium bromide, Umeclidinium, or Glycopyrronium.

Triple Therapy (LABA + LAMA + ICS): Patients receive the above combination of LABA and LAMA plus an inhaled corticosteroid (ICS) such as Budesonide, Fluticasone, or Beclometasone.

These medications may be administered either as fixed-dose combination inhalers or as separate inhalers, depending on patient needs and physician discretion. The treatment regimen is individualized based on clinical condition, prior therapy, and symptom severity.

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.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: DRUG

Patients in this group receive standard pharmacological treatment for COPD according to current clinical guidelines. Treatment includes either dual or triple inhaler therapy:

Dual Therapy (LABA + LAMA): Patients receive a long-acting beta-agonist (LABA) such as Formoterol, Salmeterol, Olodaterol, Vilanterol, or Indacaterol, in combination with a long-acting muscarinic antagonist (LAMA) such as Tiotropium bromide, Umeclidinium, or Glycopyrronium.

Triple Therapy (LABA + LAMA + ICS): Patients receive the above combination of LABA and LAMA plus an inhaled corticosteroid (ICS) such as Budesonide, Fluticasone, or Beclometasone.

These medications may be administered either as fixed-dose combination inhalers or as separate inhalers, depending on patient needs and physician discretion. The treatment regimen is individualized based on clinical condition, prior therapy, and symptom severity.

Interventions

Acupuncture

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.

Intervention Type: BEHAVIORAL

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

Patients in this group receive standard pharmacological treatment for COPD according to current clinical guidelines. Treatment includes either dual or triple inhaler therapy:

Dual Therapy (LABA + LAMA): Patients receive a long-acting beta-agonist (LABA) such as Formoterol, Salmeterol, Olodaterol, Vilanterol, or Indacaterol, in combination with a long-acting muscarinic antagonist (LAMA) such as Tiotropium bromide, Umeclidinium, or Glycopyrronium.

Triple Therapy (LABA + LAMA + ICS): Patients receive the above combination of LABA and LAMA plus an inhaled corticosteroid (ICS) such as Budesonide, Fluticasone, or Beclometasone.

These medications may be administered either as fixed-dose combination inhalers or as separate inhalers, depending on patient needs and physician discretion. The treatment regimen is individualized based on clinical condition, prior therapy, and symptom severity.

Intervention Type: DRUG

Other Intervention Names

Dual therapy (LAMA+LABA); Triple Therapy (LAMA+LABA+ICS)

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medeniyet University

OTHER

Sponsor Role: lead

Responsible Party

Bilinç Doğruöz Karatekin

MD, Specialist of PMR,Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Medeniyet University Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MU Acupuncture and COPD

Identifier Type: -

Identifier Source: org_study_id