Chronic Pulmonary Obstruction
Conditions
Brief summary
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: * Does laser acupuncture, when combined with standard pharmacological treatment, improve lung function (measured by FEV1% and FEV1/FVC ratio) more than sham laser acupuncture after 4 weeks of therapy? * Does this combination also lead to better quality of life, as assessed by the COPD Assessment Test (CAT) and the St. George's Respiratory Questionnaire (SGRQ), compared to the control group, after 4 and 8 weeks? * Is there a correlation between lung function (FEV1%) and quality of life scores (CAT and SGRQ)? * Are there any significant adverse effects caused by laser acupuncture compared to sham treatment? Participants will: * Undergo spirometry and complete CAT and SGRQ questionnaires. * Receive either laser acupuncture or sham laser acupuncture sessions. * Return for follow-up assessments at 4 and 8 weeks.
Interventions
DEVICELaser Acupuncture
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.
DEVICESham Laser Acupuncture
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.
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 assessor. Group allocation will not be disclosed to them to minimize assessment bias
Intervention model description
The intervention group will receive laser acupuncture, while the control group will receive sham laser acupuncture
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with stable chronic obstructive pulmonary disease (COPD) based on the Global Initiative for COPD (GOLD). * No acute exacerbation in the last 4 weeks. * Male or female participants aged 20 to 80 years. * Willing to participate in the study until completion and has signed informed consent.
Exclusion criteria
* History of lung surgery as treatment for COPD. * Psychiatric or cognitive disorders. * Underwent acupuncture within the last 2 weeks. * Pregnant or breastfeeding. * Presence of wounds or skin disorders at the laser acupuncture site. * History of uncontrolled epilepsy. * Fever \> 38.0°C.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forced Expiratory Volume in One Second (FEV1%) | Baseline and 4 weeks after intervention | Pulmonary function will be assessed using spirometry to measure the percentage of the predicted FEV1 value. |
| FEV1/FVC Ratio | Baseline and 4 weeks after intervention | Pulmonary function will also be evaluated by calculating the FEV1/FVC ratio through spirometry |
| COPD Assessment Test (CAT) Score | Baseline, 4 weeks, and 8 weeks after intervention | 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. |
| St. George's Respiratory Questionnaire (SGRQ) Score | Baseline, 4 weeks, and 8 weeks after intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between FEV1% and Quality of Life Scores | Baseline, 4 weeks, and 8 weeks | 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. |
| Adverse Events Related to Intervention | Immediately post-intervention until 8 weeks | Any adverse events after the intervention, such as infection, pain, or skin irritation at the laser site, will be monitored and recorded. |
Countries
Indonesia
Outcome results
None listed