Chronic Pulmonary ObstructionNCT07030452
Laser Acupuncture for Pulmonary Function Test and Quality of Life in COPD Patients
A study testing Laser Acupuncture in people with Chronic Pulmonary Obstruction, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Pulmonary Obstruction
- What is being tested?
- Laser Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Aug 2025to 10 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of Laser Acupuncture on Pulmonary Function Test and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease)
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?
Read more
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
- Being tested
- Laser Acupuncture, Sham Laser Acupuncture
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser AcupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Laser Acupuncture Receives: Device: Laser Acupuncture |
| Control Group | Sham comparator | Sham Laser Acupuncture Receives: Device: Sham Laser Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in One Second (FEV1%)
Pulmonary function will be assessed using spirometry to measure the percentage of the predicted FEV1 value.
Measured: Baseline and 4 weeks after intervention
FEV1/FVC Ratio
Pulmonary function will also be evaluated by calculating the FEV1/FVC ratio through spirometry
Measured: 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.
Measured: 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.
Measured: Baseline, 4 weeks, and 8 weeks after intervention
Secondary outcomes (2)
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.
Measured: 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.
Measured: Immediately post-intervention until 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Aug 2025
- Primary completion10 Dec 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pulmonary ObstructionStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The intervention group will receive laser acupuncture, while the control group will receive sham laser acupuncture
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dwi Lestari Ayuningtyas, Universitas Indonesia
- Investigators
- KPEK FKUI-RSCM, Principal investigator, The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030452
- Sponsor's protocol ID
- 25-05-0725
- Status last verified
- Dec 2025
- First submitted
- 12 Jun 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Laser Acupuncture on Pulmonary Function Test and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease)
- ClinicalTrials.gov ID
- NCT07030452
- Acronym / sponsor ID
- 25-05-0725
- Conditions
- Chronic Pulmonary Obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention group will receive laser acupuncture, while the control group will receive sham laser acupuncture
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Laser AcupunctureLaser Acupuncture |
| Control Group | Sham comparator | Device: Sham Laser AcupunctureSham Laser Acupuncture |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser AcupunctureLaser 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. | Device | Intervention Group |
| Sham Laser AcupunctureSham 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. | Device | Control Group |
Primary outcome
Forced Expiratory Volume in One Second (FEV1%)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
Correlation Between FEV1% and Quality of Life Scores
Time frame: Baseline, 4 weeks, and 8 weeks
Adverse Events Related to Intervention
Time frame: Immediately post-intervention until 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KPEK FKUI-RSCM principal investigator
The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Acupuncture in people with Chronic Pulmonary Obstruction, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Expiratory Volume in One Second (FEV1%) (time frame: Baseline and 4 weeks after intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.