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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
34
TEA is performed once at bilateral ST36 (perpendicular insertion) and BL13 (oblique insertion toward EX-B1) using absorbable PDO thread (CARA® 30G × 38 mm). Standard aseptic procedures are followed. Bleeding is controlled, and insertion sites are covered. Participants continue their routine pharmacological COPD treatment.
Sham TEA involves taping needles onto the surface of bilateral ST36 and BL13 without skin penetration or thread insertion. The direction toward EX-B1 is mimicked without actual insertion. All procedures, including marking and aseptic preparation, are performed identically to maintain blinding. Participants continue their routine pharmacological COPD treatment.
Universitas Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia
Six-minute walking test (6MWT)
Functional capacity will be assessed using the six-minute walking test (6MWT), measured as the distance (in meters) walked in six minutes.
Time frame: Baseline, 1 month, 2 months, 3 months after intervention
Modified Medical Research Council (mMRC) Dyspnea Scale
Dyspnea will be evaluated using the mMRC scale, scored from 0 to 4 based on the degree of breathlessness.
Time frame: Baseline, 1 month, 2 months, 3 months after intervention
COPD Assessment Test (CAT) Score
Health status and quality of life will be assessed using the CAT questionnaire, scored from 0 to 40. Higher scores indicate worse health status.
Time frame: Baseline, 1 month, 2 months, 3 months after intervention
St. George's Respiratory Questionnaire (SGRQ) Score
Quality of life will be evaluated using the SGRQ, which includes symptoms, activity, and impact domains. Scores range from 0 to 100, with higher scores indicating poorer quality of life.
Time frame: Baseline, 1 month, 2 months, 3 months
Frequency of Acute Exacerbation
The number of acute exacerbation events of COPD will be recorded over the study period.
Time frame: From baseline to 3 months post-intervention
Time to First Acute Exacerbation
Time (in days) from intervention to the first recorded acute exacerbation of COPD will be measured.
Time frame: From baseline to 3 months post-intervention
Frequency of Hospitalization
The total number of hospital admissions due to COPD-related causes will be documented.
Time frame: From baseline to 3 months
Duration of Hospitalization
The cumulative duration (in days) of hospitalization related to COPD will be recorded.
Time frame: From baseline to 3 months
Adverse Events Related to Intervention
Any adverse events occurring after the intervention, including infection, pain, or skin irritation at the insertion site, will be monitored and recorded.
Time frame: Immediately post-intervention until 3 months
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