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

Not Applicable

Not yet recruiting

• Conditions: Chronic Pulmonary Obstruction

• Registration Number: NCT07030452
• Lead Sponsor: Indonesia University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-06-12
• Study First Posted: 2025-06-22
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-27
• Study Start: 2025-08-01
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Universitas Indonesia; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia