Acupuncture for Persistent Dyspnea Despite Medical Treatment in COPD

NCT07058259 | Active Not Recruiting

• 1 other identifier: MU Acupuncture and COPD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Acupuncture

Keywords

COPD; ACUPUNCTURE; dyspnea; chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Standard COPD Pharmacological Treatment Group (Control)

ACTIVE COMPARATOR

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)

Acupuncture + Standard COPD Pharmacological Treatment Group (Intervention)

EXPERIMENTAL

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.

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

Interventions

Acupuncture 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.

Acupuncture + Standard COPD Pharmacological Treatment Group (Intervention)

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

Also known as: Dual therapy (LAMA+LABA), Triple Therapy (LAMA+LABA+ICS)

Acupuncture + Standard COPD Pharmacological Treatment Group (Intervention); Standard COPD Pharmacological Treatment Group (Control)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University Faculty of Medicine

Istanbul, 34732, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Interventions

Acupuncture Therapy; laminin A

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Specialist of PMR,Principal Investigator

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 10, 2025
• Study Start: November 15, 2024
• Primary Completion: June 30, 2025
• Study Completion: January 15, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)