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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Thread-embedding acupuncture |
|
| Control group | Sham Comparator | Sham thread-embedding acupuncture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| KPEK FKUI-RSCM | The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Indonesia | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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The intervention group will receive TEA, while the control group will receive sham TEA.
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Blinding will be applied to participants and outcome assessors. Group allocation will not be disclosed to them to minimize assessment bias.
|
| 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. |
|
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 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |