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

NCT06948578 | Completed

• 1 other identifier: 25-04-0473
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Frequency of Acute Exacerbation

  From baseline to 3 months post-intervention

• Time to First Acute Exacerbation

  From baseline to 3 months post-intervention

• Frequency of Hospitalization

  From baseline to 3 months

• Duration of Hospitalization

  From baseline to 3 months

• Adverse Events Related to Intervention

  Immediately post-intervention until 3 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Thread-embedding acupuncture

Device: Thread embedding-acupuncture

Control group

SHAM COMPARATOR

Sham thread-embedding acupuncture

Device: Sham thread-embedding acupuncture

Interventions

Thread embedding-acupuncture 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.

Intervention Group

Sham thread-embedding acupuncture 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.

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• KPEK FKUI-RSCM

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding will be applied to participants and outcome assessors. Group allocation will not be disclosed to them to minimize assessment bias.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The intervention group will receive TEA, while the control group will receive sham TEA.

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: July 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)