Percutaneous NephrolithotomyNCT06783556
The Analgesia Effect of Electroacupuncture Battlefield Acupuncture Versus Sham Electroakupuncture Post Surgery
A study testing The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy in people with Percutaneous Nephrolithotomy, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Percutaneous Nephrolithotomy
- What is being tested?
- The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 20 Jan 2025to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Universitas Indonesia
Jakarta Pusat, DKI Jakarta, 10430
Hermin Widyaprastuti, +6281286190436, hermin.widyaprastuti1@gmail.com
About this study
Official title: 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?
Read more
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
- Conditions
- Percutaneous Nephrolithotomy
- Being tested
- The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy, The sham electroacupuncture and paracetamol intravenous therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapyDevice
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.
The sham electroacupuncture and paracetamol intravenous therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy Receives: Device: The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy |
| Control Group | Sham comparator | The sham electroacupuncture and paracetamol intravenous therapy Receives: Device: The sham electroacupuncture and paracetamol intravenous therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before therapy, minute 0, hour 8, hour 24, hour 48
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start20 Jan 2025 (estimated)
- Primary completion20 Apr 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous NephrolithotomyStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy will be designated as the intervention group, while the sham electroacupuncture and paracetamol intravenous therapy will be designated as the control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hermin Widyaprastuti, Universitas Indonesia
- Investigators
- KPEK FKUI-RSCM, Principal investigator, The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783556
- Sponsor's protocol ID
- 24-12-1845
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06783556
- Acronym / sponsor ID
- 24-12-1845
- Conditions
- Percutaneous Nephrolithotomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 20 Apr 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy will be designated as the intervention group, while the sham electroacupuncture and paracetamol intravenous therapy will be designated as the control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapyThe Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy |
| Control Group | Sham comparator | Device: The sham electroacupuncture and paracetamol intravenous therapyThe sham electroacupuncture and paracetamol intravenous therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapyElectroacupuncture 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. | Device | Intervention Group |
| The sham electroacupuncture and paracetamol intravenous therapySham 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. | Device | Control Group |
Primary outcome
Visual Analogue Scale
Time frame: Before therapy, minute 0, hour 8, hour 24, hour 48
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.
3 secondary outcomes
Analgesic dose reduction
Time frame: hour 8, hour 24, hour 48
Short Form 36 (SF-36) Questionnaire
Time frame: Before therapy, day 7
Adverse effects
Time frame: Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Percutaneous Nephrolithotomy
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Recruiting
Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
Kidney Stone
Recruiting
Supine vs. Prone Mini-PCNL in Children
Kidney Calculi (or Renal Calculi / Nephrolithiasis), Supine Mini Percutaneous Nephrolithotomy
Recruiting
Nephrostomy Tract Infiltration for Pain Control After PCNL
Postoperative Pain, Kidney Calculi
Not yet recruitingPhase 4
Effect of a Low-Dose Ketamine-Dexmedetomidine-Based Opioid-Sparing Anesthesia Protocol on Postoperative Quality of Recovery After Percutaneous Nephrolithotomy
Nephrolithiasis, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
KPEK FKUI-RSCM principal investigator
The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy in people with Percutaneous Nephrolithotomy, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hermin Widyaprastuti, MD (+6281286190436, widyaprastuti.hermin1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: Before therapy, minute 0, hour 8, hour 24, hour 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.