NCT06948578

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Chronic Pulmonary Obstruction

Interventions

Type	Name	Description
DEVICE	Thread embedding-acupuncture	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.
DEVICE	Sham thread-embedding acupuncture	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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2025-04-29
• Last updated: 2025-12-29

Locations

1 site across 1 country: Indonesia