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This clinical trial aims to evaluate the effectiveness and safety of laser acupuncture as an adjunct therapy in patients with chronic obstructive pulmonary disease (COPD). The main research questions are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Laser Acupuncture |
|
| Control Group | Sham Comparator | Sham Laser Acupuncture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Acupuncture | Device | Laser acupuncture irradiation was performed using an RJ Laser laserpen with a wavelength of 785 nm and an output power of 50 mW. The laser probe was positioned perpendicularly to the skin surface, using a continuous wave mode with a dose of 4 Joules. The acupuncture points targeted were EXB1 and CV17, as well as BL13 and ST36 on both sides of the body. Each point received irradiation for 1 minute and 20 seconds. During the therapy session, subjects wore a headset playing music and protective glasses. The treatment was administered twice a week for a total of 8 sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in One Second (FEV1%) | Pulmonary function will be assessed using spirometry to measure the percentage of the predicted FEV1 value. | Baseline and 4 weeks after intervention |
| FEV1/FVC Ratio | Pulmonary function will also be evaluated by calculating the FEV1/FVC ratio through spirometry | Baseline and 4 weeks after intervention |
| COPD Assessment Test (CAT) Score | Health status and quality of life will be assessed using the CAT questionnaire, which scores from 0 to 40. Higher scores indicate worse health status. | Baseline, 4 weeks, and 8 weeks after intervention |
| St. George's Respiratory Questionnaire (SGRQ) Score | Quality of life will be assessed using the SGRQ, which includes symptom, activity, and impact domains. Scores range from 0 to 100, with higher scores indicating poorer quality of life. | Baseline, 4 weeks, and 8 weeks after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between FEV1% and Quality of Life Scores | The correlation between FEV1% and CAT/SGRQ scores will be analyzed. Quality of life was assessed using the COPD Assessment Test (CAT) and the St. George's Respiratory Questionnaire (SGRQ). The CAT score ranges from 0 to 40, with higher scores indicating a worse impact of COPD on the patient's health status. The SGRQ score ranges from 0 to 100, where higher scores indicate poorer quality of life. |
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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 laser acupuncture, while the control group will receive sham laser acupuncture
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Blinding will be applied to participants and outcome assessor. Group allocation will not be disclosed to them to minimize assessment bias
|
| Sham Laser Acupuncture | Device | Sham laser acupuncture irradiation was conducted using an RJ Laser laserpen with a wavelength of 785 nm and an output power of 50 mW at the acupuncture points EXB1 and CV17, as well as BL13 and ST36 on both sides of the body. However, the laser device was not activated, and no radiation was delivered to the patient. The laser probe was positioned perpendicularly to the skin surface at the same acupuncture points, but without activating the laser. During the session, subjects wore a headset with music and protective glasses, similar to the active treatment group. The sham treatment was administered twice a week for a total of 8 sessions. |
|
| Baseline, 4 weeks, and 8 weeks |
| Adverse Events Related to Intervention | Any adverse events after the intervention, such as infection, pain, or skin irritation at the laser site, will be monitored and recorded. | Immediately post-intervention until 8 weeks |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |