Laser Acupuncture for Pulmonary Function Test and Quality of Life in COPD Patients

Universitas Indonesia40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Pulmonary Obstruction

Interventions

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.

Sham Laser AcupunctureDEVICE

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Forced Expiratory Volume in One Second (FEV1%)

Pulmonary function will be assessed using spirometry to measure the percentage of the predicted FEV1 value.

Time frame: Baseline and 4 weeks after intervention

FEV1/FVC Ratio

Pulmonary function will also be evaluated by calculating the FEV1/FVC ratio through spirometry

Time frame: 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.

Time frame: 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.

Time frame: Baseline, 4 weeks, and 8 weeks after intervention

Secondary Outcomes

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.

Time frame: 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.

Time frame: Immediately post-intervention until 8 weeks