Chronic Pulmonary Obstruction
Conditions
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
Interventions
DEVICEThread 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 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.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Blinding will be applied to participants and outcome assessors. Group allocation will not be disclosed to them to minimize assessment bias.
Intervention model description
The intervention group will receive TEA, while the control group will receive sham TEA.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six-minute walking test (6MWT) | 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. |
| Modified Medical Research Council (mMRC) Dyspnea Scale | 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. |
| COPD Assessment Test (CAT) Score | 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. |
| St. George's Respiratory Questionnaire (SGRQ) Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Acute Exacerbation | From baseline to 3 months post-intervention | The number of acute exacerbation events of COPD will be recorded over the study period. |
| Adverse Events Related to Intervention | 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. |
| Time to First Acute Exacerbation | From baseline to 3 months post-intervention | Time (in days) from intervention to the first recorded acute exacerbation of COPD will be measured. |
| Frequency of Hospitalization | From baseline to 3 months | The total number of hospital admissions due to COPD-related causes will be documented. |
| Duration of Hospitalization | From baseline to 3 months | The cumulative duration (in days) of hospitalization related to COPD will be recorded. |
Countries
Indonesia
Outcome results
None listed