Thread-Embedding Acupuncture for Functional and QoL Improvement in COPD Patients

Effectiveness and Safety of Thread-Embedding Acupuncture in Improving Functional Capacity and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease

The goal of this clinical trial is to learn if thread-embedding acupuncture (TEA) can improve functional capacity and quality of life of chronic pulmonary disease (COPD) patients. The main questions it aims to answer are:

• Does TEA, when combined with standard treatment, improve functional capacity measured by the six-minute walking test (6MWT) and the modified Medical Research Council (mMRC) scale at 1, 2, and 3 months after the intervention?
• Does TEA, when combined with standard treatment, improve quality of life as measured by the COPD Assessment Test (CAT) and the St. George's Respiratory Questionnaire (SGRQ) at 1, 2, and 3 months after intervention? Researchers will compare TEA to sham TEA (a placebo procedure without thread implantation) to determine if TEA leads to meaningful improvements in COPD patients.

Participants will:

• Complete assessment using 6MWT, mMRC, CAT, and SGRQ
• Receive one session of either TEA or sham TEA
• Return to the clinic once a month for follow-up assessments over a 3-month period

Inclusion Criteria:

• Male or female participants aged 18 to 70 years.
• Body Mass Index (BMI) ≥18.5 kg/m².
• Diagnosed with stable chronic obstructive pulmonary disease (COPD) based on GOLD criteria.
• Willing to participate in the study until completion and has signed informed consent.

Exclusion Criteria:

• Pregnant women.
• Presence of tumors, wounds, inflammation, or skin infection at the needling area.
• Blood disorders or use of blood-thinning medications (antiplatelets or anticoagulants) with INR > 2.0.
• Uncontrolled heart disease or diabetes.
• Capillary blood glucose level ≥200 mg/dL (measured using glucometer).
• History of malignancy, uncontrolled epilepsy, or psychiatric disorders.
• Known allergy to stainless steel or polydioxanone (PDO) thread.
• Undergoing acupuncture therapy within the last 2 weeks or thread-embedding acupuncture (TEA) within the last 6 months.