Press Needle Acupuncture for Pain and Quality of Life in Lung Cancer Patients

NCT07112950 | Not Yet Recruiting

• 1 other identifier: 25-05-0758
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Cancer Patients

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS) for Pain

  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

  Before therapy, Day 1, Day 3, Day 7, and Day 14

Secondary Outcomes (1)

• Functional Assessment of Cancer Therapy - Lung (FACT-L)

  Before therapy, Day 7, and Day 14

Study Arms (2)

Intervention Group

EXPERIMENTAL

The press needle acupuncture and standart therapy

Device: Press Needle Acupuncture and standart therapy

Control Group

SHAM COMPARATOR

The sham press needle acupuncture and standart therapy

Device: Press Needle Acupuncture and standart therapy

Interventions

Press Needle Acupuncture and standart therapy DEVICE

The patient will have a press needle applied, which will be removed on the seventh day.

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Study Officials

• KPEK FKUI-RSCM

  The Health Research Ethics Commitee of Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuanti Yunus Konda, MD

CONTACT

+6285240864987; yuanti.yunus@ui.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the participants and the outcome assessors will be blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Press needle acupuncture and standart therapy will be designated as the intervention group, while the sham press needle acupucnture and standart therapy will be designated as the control group

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: August 11, 2025
• Primary Completion: October 31, 2025
• Study Completion: December 1, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)