Acupuncture for Persistent Dyspnea Despite Medical Treatment in COPD (COPD)

The Effect of Acupuncture in COPD Patients With Persistent Dyspnea Despite Medical Treatment

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acupuncture; COPD (Chronic Obstructive Pulmonary Disease)
• Intervention / Treatment: Drug: Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS); Behavioral: Acupuncture

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34732
    • Istanbul Medeniyet University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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.; Other Names: Dual therapy (LAMA+LABA); Triple Therapy (LAMA+LABA+ICS)
Experimental: 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.	Drug: 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.; Other Names: Dual therapy (LAMA+LABA); Triple Therapy (LAMA+LABA+ICS); Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Medical Research Council (mMRC) Dyspnea Scale	Change in dyspnea severity measured by the Modified Medical Research Council (mMRC) Dyspnea Scale from baseline to 6 weeks.	From baseline to the end of treatment at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD Assessment Test (CAT)	Change in COPD Assessment Test (CAT) score.The CAT score evaluates overall symptom burden and quality of life in COPD patients.	From baseline to the end of treatment at 6 weeks
Change in Forced Expiratory Volume in 1 Second (FEV1)	FEV1 will be measured via spirometry pre- and post-bronchodilator to assess lung function	From baseline to the end of treatment at 6 weeks
6-Minute Walk Test (6MWT)	Change in exercise capacity measured by the 6-Minute Walk Test (6MWT) distance	From baseline to the end of treatment at 6 weeks
Incremental Shuttle Walk Test (ISWT)	Change in exercise tolerance assessed by the Incremental Shuttle Walk Test (ISWT)	From baseline to the end of treatment at 6 weeks
Change in Forced Vital Capacity (FVC)	FVC will be measured via spirometry pre- and post-bronchodilator to assess pulmonary capacity.	From baseline to the end of treatment at 6 weeks
Change in FEV1/FVC Ratio	The FEV1/FVC ratio will be calculated from spirometry values to evaluate airway obstruction severity.	From baseline to the end of treatment at 6 weeks

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): January 15, 2026

Study Registration Dates

• First Submitted: June 22, 2025
• First Submitted That Met QC Criteria: June 30, 2025
• First Posted (Actual): July 10, 2025

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: COPD; dyspnea; chronic obstructive pulmonary disease; ACUPUNCTURE
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea
• Other Study ID Numbers: MU Acupuncture and COPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No