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

University of Indonesia (UI)

Status: Completed

Conditions: Chronic Pulmonary Obstruction

Treatments: Device: Sham thread-embedding acupuncture; Device: Thread embedding-acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06948578

25-04-0473

Details and patient eligibility

About

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

Enrollment: 34 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Thread-embedding acupuncture

Treatment:

Device: Thread embedding-acupuncture

Control group

Sham Comparator group

Description:

Sham thread-embedding acupuncture

Treatment:

Device: Sham thread-embedding acupuncture