The Analgesia Effect of Electroacupuncture Battlefield Acupuncture Versus Sham Electroakupuncture Post Surgery

The Analgesia Effect of Electroacupuncture of Battlefield Acupuncture (BFA) Versus Sham Electroacupuncture on Pain, Analgesic Dose Reduction and Quality of Life Post Percutaneous Nephrolithotomy Surgery

The goal of this clinical trial is to learn the effect of ear electroacupuncture BFA therapy in reducing pain, analgesic dose, and improving patient quality of live post percutaneous nephrolithotomy surgery. The main questions it aims to answer are:

• Does BFA ear electroacupuncture reduce postoperative pain of percutaneous nephrolithotomy surgery better than sham electroacupuncture group?
• Does BFA ear electroacupuncture reduce postoperative analgesic dose of percutaneous nephrolithotomy surgery better than sham electroacupuncture group?
• Does BFA ear electroacupuncture improve postoperative quality of life of percutaneous nephrolithotomy surgery better than sham electroacupuncture group?

Researchers will compare ear electroacupuncture BFA to sham electroacupuncture to see the different analgesia effect between these groups.

Participants will:

• Get ear electroacupuncture BFA or sham electroacupuncture therapy, 2 hours before surgery for 30 minutes
• Take drug paracetamol 1000 mg intravenous after surgery according to the needs of the patient's pain complaints after surgery in both groups

Study Overview

• Status: Not yet recruiting
• Conditions: Percutaneous Nephrolithotomy
• Intervention / Treatment: Device: The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy; Device: The sham electroacupuncture and paracetamol intravenous therapy

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hermin Widyaprastuti, MD; Phone Number: +6281286190436; Email: widyaprastuti.hermin1@gmail.com

Study Locations

• Indonesia
  • Dki Jakarta
    • Jakarta Pusat, Dki Jakarta, Indonesia, 10430
      • Universitas Indonesia
      • Contact: Hermin Widyaprastuti; Phone Number: +6281286190436; Email: hermin.widyaprastuti1@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men or women aged 18-65 years
• Patients who have been diagnosed with kidney stones measuring > 2 cm and will undergo PCNL surgery
• VAS score <7, assessed 2 hours before PCNL surgery
• Receive standard analgesic therapy
• Willing to participate in this study until completion and sign an informed consent.

Exclusion Criteria:

• Kidney anatomical abnormalities
• Ear deformities (microtia)
• Patients with cognitive impairment, uncooperative (receiving antidepressants or strong opioid or narcotic analgesics)
• Tumors, wounds or skin infections in the needling area.
• Heart rhythm disorder, unstable hemodynamics that require intensive care including extremely high body temperature and using a pacemaker.
• Allergy to acupuncture needles or certain metals
• Patients who have had a DJ stent or nephrostomy before PCNL
• History of metal implants in the body except amalgam

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy	Device: The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy; Electroacupuncture therapy was performed 2 hours before PCNL surgery. Needle insertion was performed perpendicularly at the Battlefield Acupuncture (BFA) points of the ear, namely MA-IT1 Cingulate gyrus, MA-AT2 Thalamus, MA-H2 Omega2, MA-H1 Point Zero and MA-TF1 Shenmen bilaterally. Then the electrostimulator cable was connected to the ear acupuncture points MA-AT2 and MA-TF1 bilaterally on the same side and then fixed with plaster. Electroacupuncture uses continuous waves of 2 Hz frequency with an intensity that can be tolerated by the patient for 30 minutes. Patients also received standard therapy with 1000 mg intravenous paracetamol with a maximum of 3 times administration per 24 hours and can be reduced according to the needs of the patient's pain complaints.
Sham Comparator: Control Group; The sham electroacupuncture and paracetamol intravenous therapy	Device: The sham electroacupuncture and paracetamol intravenous therapy; Sham electroacupuncture therapy was performed 2 hours before PCNL surgery. Needle only attached using plester (not inserted) at the Battlefield Acupuncture (BFA) points of the ear, namely MA-IT1 Cingulate gyrus, MA-AT2 Thalamus, MA-H2 Omega2, MA-H1 Point Zero and MA-TF1 Shenmen bilaterally. Then the electrostimulator cable was connected to the ear acupuncture points MA-AT2 and MA-TF1 bilaterally on the same side and then fixed with plaster. Electroacupuncture device is not turned on. The therapy is carried out for 30 minutes. Patients also received standard therapy with 1000 mg intravenous paracetamol with a maximum of 3 times administration per 24 hours and can be reduced according to the needs of the patient's pain complaints.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	Visual Analogue Scale is the tool that measures pain intensity. It use a scale with a minimum range of 0 and a maximum of 10, where 0 indicates no pain and 10 indicates the worst pain. Higher scores indicate worse pain.	Before therapy, minute 0, hour 8, hour 24, hour 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic dose reduction	Paracetamol 1000 mg IV is given to patient with a maximum of 3 times administration per 24 hours. The dose of paracetamol can be reduced when the patien's pain score of Visual Analogue Score is less than 3. Measurements were made by measuring the cumulative dose of analgesics after acupuncture therapy. Then compared between the two groups, which group had a greater decrease in analgesic dose.	hour 8, hour 24, hour 48
Short Form 36 (SF-36) Questionnaire	The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status.	Before therapy, day 7
Adverse effects	Record the adverse effects that occur after acupuncture therapy. It will be monitored for 7 days after therapy and recorded on the 7th day by assessor.	Day 7

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: KPEK FKUI-RSCM, the Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2025
• Primary Completion (Estimated): April 20, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 18, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Acetaminophen
• Other Study ID Numbers: 24-12-1845

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No