Clinical trial NCT06948578: Thread-Embedding Acupuncture for Functional and QoL Improvement in COPD Patients
Official title: Effectiveness and Safety of Thread-Embedding Acupuncture in Improving Functional Capacity and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pulmonary Obstruction
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The intervention group will receive TEA, while the control group will receive sham TEA.
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Six-minute walking test (6MWT)
timeFrame: Baseline, 1 month, 2 months, 3 months after intervention
measure: Modified Medical Research Council (mMRC) Dyspnea Scale
timeFrame: Baseline, 1 month, 2 months, 3 months after intervention
measure: COPD Assessment Test (CAT) Score
timeFrame: Baseline, 1 month, 2 months, 3 months after intervention
measure: St. George's Respiratory Questionnaire (SGRQ) Score
timeFrame: Baseline, 1 month, 2 months, 3 months
Secondary outcomes:
measure: Frequency of Acute Exacerbation
timeFrame: From baseline to 3 months post-intervention
measure: Time to First Acute Exacerbation
timeFrame: From baseline to 3 months post-intervention
measure: Frequency of Hospitalization
timeFrame: From baseline to 3 months
measure: Duration of Hospitalization
timeFrame: From baseline to 3 months
measure: Adverse Events Related to Intervention
timeFrame: Immediately post-intervention until 3 months
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Universitas Indonesia
state: DKI Jakarta
Study officials:
affiliation: The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
name: KPEK FKUI-RSCM
role: PRINCIPAL_INVESTIGATOR
References: