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

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 Overview

• Status: Completed
• Conditions: Chronic Pulmonary Obstruction
• Intervention / Treatment: Device: Thread embedding-acupuncture; Device: Sham thread-embedding acupuncture

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Universitas Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Thread-embedding acupuncture	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.
Sham Comparator: Control group; Sham thread-embedding acupuncture	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline, 1 month, 2 months, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Acute Exacerbation	The number of acute exacerbation events of COPD will be recorded over the study period.	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.	From baseline to 3 months post-intervention
Frequency of Hospitalization	The total number of hospital admissions due to COPD-related causes will be documented.	From baseline to 3 months
Duration of Hospitalization	The cumulative duration (in days) of hospitalization related to COPD will be recorded.	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.	Immediately post-intervention until 3 months

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: KPEK FKUI-RSCM, the Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: April 22, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 25-04-0473

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No