Chronic Pulmonary ObstructionNCT06948578
Thread-Embedding Acupuncture for Functional and QoL Improvement in COPD Patients
A study testing Thread embedding-acupuncture in people with Chronic Pulmonary Obstruction, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to learn if thread-embedding acupuncture (TEA) can improve functional capacity and quality of life of chronic pulmonary disease (COPD) patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pulmonary Obstruction
- What is being tested?
- Thread embedding-acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2025to 30 Nov 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged 18 to 70 years.
- Body Mass Index (BMI) ≥18.5 kg/m².
- Diagnosed with stable chronic obstructive pulmonary disease (COPD) based on GOLD criteria.
- Willing to participate in the study until completion and has signed informed consent.
Who cannot join
- Pregnant women.
- Presence of tumors, wounds, inflammation, or skin infection at the needling area.
- Blood disorders or use of blood-thinning medications (antiplatelets or anticoagulants) with INR > 2.0.
- Uncontrolled heart disease or diabetes.
- Capillary blood glucose level ≥200 mg/dL (measured using glucometer).
- History of malignancy, uncontrolled epilepsy, or psychiatric disorders.
- Known allergy to stainless steel or polydioxanone (PDO) thread.
- Undergoing acupuncture therapy within the last 2 weeks or thread-embedding acupuncture (TEA) within the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of Thread-Embedding Acupuncture in Improving Functional Capacity and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease
The goal of this clinical trial is to learn if thread-embedding acupuncture (TEA) can improve functional capacity and quality of life of chronic pulmonary disease (COPD) patients. The main questions it aims to answer are:
- Does TEA, when combined with standard treatment, improve functional capacity measured by the six-minute walking test (6MWT) and the modified Medical Research Council (mMRC) scale at 1, 2, and 3 months after the intervention?
- Does TEA, when combined with standard treatment, improve quality of life as measured by the COPD Assessment Test (CAT) and the St. George's Respiratory Questionnaire (SGRQ) at 1, 2, and 3 months after intervention? Researchers will compare TEA to sham TEA (a placebo procedure without thread implantation) to determine if TEA leads to meaningful improvements in COPD patients.
Read more
Participants will:
- Complete assessment using 6MWT, mMRC, CAT, and SGRQ
- Receive one session of either TEA or sham TEA
- Return to the clinic once a month for follow-up assessments over a 3-month period
- Conditions
- Chronic Pulmonary Obstruction
- Being tested
- Thread embedding-acupuncture, Sham thread-embedding 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.
Thread embedding-acupunctureDevice
TEA is performed once at bilateral ST36 (perpendicular insertion) and BL13 (oblique insertion toward EX-B1) using absorbable PDO thread (CARA® 30G × 38 mm). Standard aseptic procedures are followed. Bleeding is controlled, and insertion sites are covered. Participants continue their routine pharmacological COPD treatment.
Sham thread-embedding acupunctureDevice
Sham TEA involves taping needles onto the surface of bilateral ST36 and BL13 without skin penetration or thread insertion. The direction toward EX-B1 is mimicked without actual insertion. All procedures, including marking and aseptic preparation, are performed identically to maintain blinding. Participants continue their routine pharmacological COPD treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Thread-embedding acupuncture Receives: Device: Thread embedding-acupuncture |
| Control group | Sham comparator | Sham thread-embedding acupuncture Receives: Device: Sham thread-embedding acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walking test (6MWT)
Functional capacity will be assessed using the six-minute walking test (6MWT), measured as the distance (in meters) walked in six minutes.
Measured: Baseline, 1 month, 2 months, 3 months after intervention
Modified Medical Research Council (mMRC) Dyspnea Scale
Dyspnea will be evaluated using the mMRC scale, scored from 0 to 4 based on the degree of breathlessness.
Measured: Baseline, 1 month, 2 months, 3 months after intervention
COPD Assessment Test (CAT) Score
Health status and quality of life will be assessed using the CAT questionnaire, scored from 0 to 40.
Higher scores indicate worse health status.
Measured: Baseline, 1 month, 2 months, 3 months after intervention
St. George's Respiratory Questionnaire (SGRQ) Score
Quality of life will be evaluated using the SGRQ, which includes symptoms, activity, and impact domains.
Scores range from 0 to 100, with higher scores indicating poorer quality of life.
Measured: Baseline, 1 month, 2 months, 3 months
Secondary outcomes (5)
Frequency of Acute Exacerbation
The number of acute exacerbation events of COPD will be recorded over the study period.
Measured: From baseline to 3 months post-intervention
Time to First Acute Exacerbation
Time (in days) from intervention to the first recorded acute exacerbation of COPD will be measured.
Measured: From baseline to 3 months post-intervention
Frequency of Hospitalization
The total number of hospital admissions due to COPD-related causes will be documented.
Measured: From baseline to 3 months
Duration of Hospitalization
The cumulative duration (in days) of hospitalization related to COPD will be recorded.
Measured: From baseline to 3 months
Adverse Events Related to Intervention
Any adverse events occurring after the intervention, including infection, pain, or skin irritation at the insertion site, will be monitored and recorded.
Measured: Immediately post-intervention until 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start1 Jul 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 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 TEA, while the control group will receive sham TEA.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natasha Setiawan, 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
- NCT06948578
- Sponsor's protocol ID
- 25-04-0473
- Status last verified
- Dec 2025
- First submitted
- 22 Apr 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Thread-Embedding Acupuncture in Improving Functional Capacity and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06948578
- Acronym / sponsor ID
- 25-04-0473
- Conditions
- Chronic Pulmonary Obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 29 Apr 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.
The goal of this clinical trial is to learn if thread-embedding acupuncture (TEA) can improve functional capacity and quality of life of chronic pulmonary disease (COPD) patients. The main questions it aims to answer are:
- Does TEA, when combined with standard treatment, improve functional capacity measured by the six-minute walking test (6MWT) and the modified Medical Research Council (mMRC) scale at 1, 2, and 3 months after the intervention?
- Does TEA, when combined with standard treatment, improve quality of life as measured by the COPD Assessment Test (CAT) and the St. George's Respiratory Questionnaire (SGRQ) at 1, 2, and 3 months after intervention? Researchers will compare TEA to sham TEA (a placebo procedure without thread implantation) to determine if TEA leads to meaningful improvements in COPD patients.
Participants will:
- Complete assessment using 6MWT, mMRC, CAT, and SGRQ
- Receive one session of either TEA or sham TEA
- Return to the clinic once a month for follow-up assessments over a 3-month period
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 TEA, while the control group will receive sham TEA.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Thread embedding-acupunctureThread-embedding acupuncture |
| Control group | Sham comparator | Device: Sham thread-embedding acupunctureSham thread-embedding acupuncture |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female participants aged 18 to 70 years.
- Body Mass Index (BMI) ≥18.5 kg/m².
- Diagnosed with stable chronic obstructive pulmonary disease (COPD) based on GOLD criteria.
- Willing to participate in the study until completion and has signed informed consent.
Key exclusion criteria (8 listed)
- Pregnant women.
- Presence of tumors, wounds, inflammation, or skin infection at the needling area.
- Blood disorders or use of blood-thinning medications (antiplatelets or anticoagulants) with INR > 2.0.
- Uncontrolled heart disease or diabetes.
- Capillary blood glucose level ≥200 mg/dL (measured using glucometer).
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 |
|---|---|---|
| Thread embedding-acupunctureTEA is performed once at bilateral ST36 (perpendicular insertion) and BL13 (oblique insertion toward EX-B1) using absorbable PDO thread (CARA® 30G × 38 mm). Standard aseptic procedures are followed. Bleeding is controlled, and insertion sites are covered. Participants continue their routine pharmacological COPD treatment. | Device | Intervention Group |
| Sham thread-embedding acupunctureSham TEA involves taping needles onto the surface of bilateral ST36 and BL13 without skin penetration or thread insertion. The direction toward EX-B1 is mimicked without actual insertion. All procedures, including marking and aseptic preparation, are performed identically to maintain blinding. Participants continue their routine pharmacological COPD treatment. | Device | Control group |
Primary outcome
Six-minute walking test (6MWT)
Time frame: Baseline, 1 month, 2 months, 3 months after intervention
Functional capacity will be assessed using the six-minute walking test (6MWT), measured as the distance (in meters) walked in six minutes.
Modified Medical Research Council (mMRC) Dyspnea Scale
Time frame: Baseline, 1 month, 2 months, 3 months after intervention
Dyspnea will be evaluated using the mMRC scale, scored from 0 to 4 based on the degree of breathlessness.
COPD Assessment Test (CAT) Score
Time frame: Baseline, 1 month, 2 months, 3 months after intervention
Health status and quality of life will be assessed using the CAT questionnaire, scored from 0 to 40. Higher scores indicate worse health status.
St. George's Respiratory Questionnaire (SGRQ) Score
Time frame: Baseline, 1 month, 2 months, 3 months
Quality of life will be evaluated using the SGRQ, which includes symptoms, activity, and impact domains. Scores range from 0 to 100, with higher scores indicating poorer quality of life.
5 secondary outcomes
Frequency of Acute Exacerbation
Time frame: From baseline to 3 months post-intervention
Time to First Acute Exacerbation
Time frame: From baseline to 3 months post-intervention
Frequency of Hospitalization
Time frame: From baseline to 3 months
Duration of Hospitalization
Time frame: From baseline to 3 months
Adverse Events Related to Intervention
Time frame: Immediately post-intervention until 3 months
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 29 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Pulmonary Obstruction
Not yet recruitingPhase 1/2
cfMSC Stem Cell Therapy Targeting COPD
Chronic Obstructive Pulmonary Disease (COPD)
Recruiting
Multimodal Assessment of NMES Effects on Respiratory and Peripheral Muscles in COPD
Chronic Obstructive Pulmonary Disease (COPD), Respiratory Muscle Dysfunction
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and Management of Chronic Airway Diseases
Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis)
RecruitingObservational study
Swiss Chronic Obstructive Pulmonary Disease (COPD) Management Cohort
Chronic Obstructive Pulmonary Disease, COPD Exacerbation
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 Thread embedding-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 8 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 29 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?
Six-minute walking test (6MWT) (time frame: Baseline, 1 month, 2 months, 3 months 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 29 Dec 2025.