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

University of Indonesia (UI)

Status: Completed

Conditions: Chronic Pulmonary Obstruction

Treatments: Device: Laser Acupuncture; Device: Sham Laser Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT07030452

25-05-0725

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Laser Acupuncture

Treatment:

Device: Laser Acupuncture

Control Group

Sham Comparator group

Description:

Sham Laser Acupuncture

Treatment:

Device: Sham Laser Acupuncture