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Completed

NCT Number: NCT06948578

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

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

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Six-minute walking test (6MWT)

    Time frame: Baseline, 1 month, 2 months, 3 months after intervention

    Functional capacity will be assessed using the six-minute walking test (6MWT), measured as the distance (in meters) walked in six minutes.

  2. Modified Medical Research Council (mMRC) Dyspnea Scale

    Time frame: Baseline, 1 month, 2 months, 3 months after intervention

    Dyspnea will be evaluated using the mMRC scale, scored from 0 to 4 based on the degree of breathlessness.

  3. COPD Assessment Test (CAT) Score

    Time frame: Baseline, 1 month, 2 months, 3 months after intervention

    Health status and quality of life will be assessed using the CAT questionnaire, scored from 0 to 40.

    Higher scores indicate worse health status.

  4. St. George's Respiratory Questionnaire (SGRQ) Score

    Time frame: Baseline, 1 month, 2 months, 3 months

    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.

Secondary outcomes

  1. Frequency of Acute Exacerbation

    Time frame: From baseline to 3 months post-intervention

    The number of acute exacerbation events of COPD will be recorded over the study period.

  2. Time to First Acute Exacerbation

    Time frame: From baseline to 3 months post-intervention

    Time (in days) from intervention to the first recorded acute exacerbation of COPD will be measured.

  3. Frequency of Hospitalization

    Time frame: From baseline to 3 months

    The total number of hospital admissions due to COPD-related causes will be documented.

  4. Duration of Hospitalization

    Time frame: From baseline to 3 months

    The cumulative duration (in days) of hospitalization related to COPD will be recorded.

  5. Adverse Events Related to Intervention

    Time frame: Immediately post-intervention until 3 months

    Any adverse events occurring after the intervention, including infection, pain, or skin irritation at the insertion site, will be monitored and recorded.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Effectiveness and Safety of Thread-Embedding Acupuncture in Improving Functional Capacity and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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