Thread-Embedding Acupuncture for Functional and QoL Improvement in COPD Patients
- Conditions
- Chronic Pulmonary Obstruction
- Registration Number
- NCT06948578
- Lead Sponsor
- Indonesia University
- Brief 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. 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 34
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Six-minute walking test (6MWT) 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 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 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 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.
- Secondary Outcome Measures
Name Time Method Frequency of Acute Exacerbation From baseline to 3 months post-intervention The number of acute exacerbation events of COPD will be recorded over the study period.
Time to First Acute Exacerbation From baseline to 3 months post-intervention Time (in days) from intervention to the first recorded acute exacerbation of COPD will be measured.
Frequency of Hospitalization From baseline to 3 months The total number of hospital admissions due to COPD-related causes will be documented.
Duration of Hospitalization From baseline to 3 months The cumulative duration (in days) of hospitalization related to COPD will be recorded.
Adverse Events Related to Intervention Immediately post-intervention until 3 months Any adverse events occurring after the intervention, including infection, pain, or skin irritation at the insertion site, will be monitored and recorded.
Trial Locations
- Locations (1)
Universitas Indonesia
🇮🇩Jakarta Pusat, DKI Jakarta, Indonesia