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

NCT ID: NCT06948578

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2025-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group

Thread-embedding acupuncture

Group Type: EXPERIMENTAL

Thread embedding-acupuncture

Intervention Type: DEVICE

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.

Control group

Sham thread-embedding acupuncture

Group Type: SHAM_COMPARATOR

Sham thread-embedding acupuncture

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Natasha Setiawan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

KPEK FKUI-RSCM

Role: PRINCIPAL_INVESTIGATOR

The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital

Locations

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

25-04-0473

Identifier Type: -

Identifier Source: org_study_id