Overview
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
Eligibility
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.