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

NCT07030452 | Completed

• 1 other identifier: 25-05-0725
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (2)

• Correlation Between FEV1% and Quality of Life Scores

  Baseline, 4 weeks, and 8 weeks

• Adverse Events Related to Intervention

  Immediately post-intervention until 8 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Laser Acupuncture

Device: Laser Acupuncture

Control Group

SHAM COMPARATOR

Sham Laser Acupuncture

Device: Sham Laser Acupuncture

Interventions

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.

Intervention Group

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.

Control Group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• KPEK FKUI-RSCM

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding will be applied to participants and outcome assessor. Group allocation will not be disclosed to them to minimize assessment bias
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The intervention group will receive laser acupuncture, while the control group will receive sham laser acupuncture

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: August 1, 2025
• Primary Completion: December 10, 2025
• Study Completion: December 10, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

ID (1)