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

NCT ID: NCT07030452

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2025-12-10

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.

Conditions

Chronic Pulmonary Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group

Laser Acupuncture

Group Type: EXPERIMENTAL

Laser Acupuncture

Intervention Type: 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.

Control Group

Sham Laser Acupuncture

Group Type: SHAM_COMPARATOR

Sham Laser Acupuncture

Intervention Type: 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.

Interventions

Laser 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.

Intervention Type: DEVICE

Sham 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Dwi Lestari Ayuningtyas

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

KPEK FKUI-RSCM

Role: PRINCIPAL_INVESTIGATOR

The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital

Locations

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

25-05-0725

Identifier Type: -

Identifier Source: org_study_id