Effectiveness and Safety of Thread-Embedding Acupuncture in Improving Functional Capacity and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indonesia University
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Six-minute walking test (6MWT)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Blinding will be applied to participants and outcome assessors. Group allocation will not be disclosed to them to minimize assessment bias.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
- •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.
Arms & Interventions
Intervention Group
Thread-embedding acupuncture
Intervention: Thread embedding-acupuncture (Device)
Control group
Sham thread-embedding acupuncture
Intervention: Sham thread-embedding acupuncture (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Frequency of Acute Exacerbation(From baseline to 3 months post-intervention)
- Time to First Acute Exacerbation(From baseline to 3 months post-intervention)
- Frequency of Hospitalization(From baseline to 3 months)
- Duration of Hospitalization(From baseline to 3 months)
- Adverse Events Related to Intervention(Immediately post-intervention until 3 months)
Investigators
Natasha Setiawan
Principal Investigator
Indonesia University