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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medeniyet University Faculty of Medicine | Istanbul | 34732 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| C084098 | laminin A |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| 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. |
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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 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |