The Effect of Press Needle Acupuncture on Pain Reduction and Quality of Life Improvement in Lung Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Indonesia University
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Visual Analogue Scale (VAS) for Pain
Study Overview
Brief Summary
The purpose of this clinical trial is to evaluate the effect of press needle acupuncture on pain management and quality of life improvement in patients with lung cancer.
The main question this study aims to answer is:
Does press needle acupuncture, when combined with standard therapy, provide better pain relief and quality of life improvement in lung cancer patients compared to standard therapy alone?
Researchers will compare press needle acupuncture to sham acupuncture to determine whether press needle acupuncture is more effective in reducing pain and improving quality of life.
Participants will:
Receive either press needle acupuncture or sham press needle acupuncture for 7 days
Visit the clinic once a week for examination and evaluation
Record improvements in pain intensity in a pain diary and assess quality of life using a quality of life questionnaire
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
the participants and the outcome assessors will be blinded to group allocation
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with a confirmed diagnosis of lung cancer through histopathology or radiology.
- •Lung cancer patients aged over 18 years.
- •Stage III-IV lung cancer patients receiving therapy at Dr. Cipto Mangunkusumo National General Hospital (RSUPN) and Tangerang District General Hospital (RSUD Kabupaten Tangerang).
- •Patients with a VAS score >10 mm for baseline pain and >40 mm during breakthrough pain.
- •Willing to participate in the study until completion by signing the informed consent form.
Exclusion Criteria
- •Lung cancer patients with deteriorating general condition.
- •Presence of wounds or infections at the press needle insertion site.
- •History of allergy to stainless steel materials.
- •Patients with blood clotting disorders: platelet count <50,000/μL, ANC <1000/mm³, or patients undergoing anticoagulant therapy with INR >2.142.
Arms & Interventions
Intervention Group
The press needle acupuncture and standart therapy
Intervention: Press Needle Acupuncture and standart therapy (Device)
Control Group
The sham press needle acupuncture and standart therapy
Intervention: Press Needle Acupuncture and standart therapy (Device)
Outcomes
Primary Outcomes
Visual Analogue Scale (VAS) for Pain
Time Frame: Before therapy, Day 1, Day 3, Day 7, and Day 14
Pain intensity will be measured using the Visual Analogue Scale (VAS), which consists of a horizontal or vertical line 10 cm (100 mm) in length, representing a continuum of pain intensity from: 0 = No pain at all 10 = Worst imaginable pain
Secondary Outcomes
- Functional Assessment of Cancer Therapy - Lung (FACT-L)(Before therapy, Day 7, and Day 14)
Investigators
Yuanti Yunus Konda
MD
Indonesia University