Postoperative PainNCT07243301
Thread Embedding Acupuncture vs Sham on Acute Pain and Quality of Life After Laparoscopic Nephrectomy of Living Donor
A study testing Thread implantation acupuncture in people with Postoperative Pain and Kidney Transplant; Complications, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This randomized, double-blind controlled study aims to evaluate the effectiveness of thread implantation acupuncture at EX-B2 L1 in reducing postoperative pain and improving quality of life in patients undergoing laparoscopic living donor nephrectomy. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Kidney Transplant; Complications
- What is being tested?
- Thread implantation acupuncture
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Feb 2025to 10 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Living kidney donors scheduled to undergo laparoscopic living donor nephrectomy.
- Aged 21-60 years.
- Willing to participate and able to sign written informed consent
Who cannot join
- Hypersensitivity to thread-embedding acupuncture (TEA).
- History of keloid formation or tendency to develop keloids.
- Skin disorders at or near the planned TEA insertion sites.
- Neurological abnormalities or lower-limb deficits on physical examination.
- History of spinal surgery or scheduled for spinal surgery within the next 7 months.
- Scoliosis based on clinical examination.
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- Other causes of low back pain, such as inflammatory spondylitis, spinal infection, or tumor.
- Planning to become pregnant within 7 months after LNDH.
- Body Mass Index (BMI) < 18 kg/m².
- Uncontrolled diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Thread Embedding Acupuncture at the First Lumbar EX-B2 Point With Sham Thread Embedding Acupuncture on Acute Pain and Quality of Life After Laparoscopic Living Donor Nephrectomy
This randomized, double-blind controlled study aims to evaluate the effectiveness of thread implantation acupuncture at EX-B2 L1 in reducing postoperative pain and improving quality of life in patients undergoing laparoscopic living donor nephrectomy. Thirty-four participants will be randomly assigned to receive either thread implantation acupuncture with polydioxanone (PDO) thread at EX-B2 L1 plus standard postoperative therapy or sham thread implantation acupuncture without thread insertion plus the same standard therapy. Pain intensity will be assessed using the Visual Analogue Scale (VAS) and quality of life with the Short-Form 36 (SF-36). The study seeks to determine whether thread implantation acupuncture provides additional analgesic and quality-of-life benefits beyond standard postoperative care.
Read the detailed description
Laparoscopic donor nephrectomy is the preferred technique for kidney donation due to its minimally invasive nature and faster recovery. However, postoperative pain and decreased quality of life remain significant issues. Excessive reliance on pharmacological analgesia can lead to adverse effects such as hepatotoxicity and gastrointestinal symptoms.
Thread implantation acupuncture involves inserting a biodegradable polydioxanone (PDO) thread into acupuncture points to provide prolonged stimulation. The EX-B2 (L1) point has been shown to modulate lumbar innervation and may help reduce nociceptive signaling associated with postoperative pain.
This double-blind randomized controlled trial compares the analgesic and quality-of-life outcomes between patients receiving thread implantation acupuncture at EX-B2 (L1) plus standard therapy and those receiving sham thread implantation acupuncture plus standard therapy. Pain intensity (VAS) will be measured pre-intervention (Day 0), then at postoperative Days 1, 2, 3, and 14. Quality of life (SF-36) will be evaluated at Day 0 and Day 14. The results are expected to strengthen evidence for thread implantation acupuncture as an adjunctive therapy for acute postoperative pain management and recovery after laparoscopic donor nephrectomy.
- Being tested
- Thread implantation acupuncture, Sham thread implantation acupuncture
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thread implantation acupunctureDevice
Thread implantation acupuncture performed bilaterally at EX-B2 (L1) using polydioxanone (PDO) thread (26G × 38 mm) inserted subcutaneously to a depth of approximately 1-1.5 cm. The procedure is conducted once under aseptic conditions before surgery, combined with standard postoperative analgesic therapy.
Sham thread implantation acupunctureDevice
Sham thread embedding acupuncture performed bilaterally at EX-B2 (L1) using a blunt needle without thread insertion, mimicking the procedure but without embedding material. Participants also receive standard postoperative therapy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Thread implantation acupuncture Receives: Device: Thread implantation acupuncture |
| Control Group | Sham comparator | Sham thread implantation acupuncture Receives: Device: Sham thread implantation acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity (Visual Analogue Scale)
Visual Analogue Scale (0-100 mm) measured at Day 0 (baseline), Day 1, 2, 3, and 14 post-surgery.
Measured: From baseline to postoperative Day 14
Secondary outcomes (3)
Change in Quality of Life (Short Form-36)
Short Form-36 questionnaire assessing eight domains of quality of life at Day 0 and Day 14.
Measured: Baseline and Day 14.
Analgesic Use
Total postoperative paracetamol dose used within 14 days.
Measured: Day 0-14.
Adverse Events Adverse Events Adverse Events
Frequency and type of adverse reactions (pain, bruising, infection, thread extrusion).
Measured: Up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start10 Feb 2025
- Primary completion10 Nov 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group will receive thread implantation acupuncture, while the control group will receive sham thread implantation acupuncture.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salman Matoaya Bustan, Universitas Indonesia
- Investigators
- KEPK FKUI-RSCM, Principal investigator, The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243301
- Sponsor's protocol ID
- 24-12-1864
- Status last verified
- Jan 2026
- First submitted
- 17 Nov 2025
- Last updated
- 8 Jan 2026
- 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 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Thread Embedding Acupuncture at the First Lumbar EX-B2 Point With Sham Thread Embedding Acupuncture on Acute Pain and Quality of Life After Laparoscopic Living Donor Nephrectomy
- ClinicalTrials.gov ID
- NCT07243301
- Acronym / sponsor ID
- 24-12-1864
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 21 Nov 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.
This randomized, double-blind controlled study aims to evaluate the effectiveness of thread implantation acupuncture at EX-B2 L1 in reducing postoperative pain and improving quality of life in patients undergoing laparoscopic living donor nephrectomy. Thirty-four participants will be randomly assigned to receive either thread implantation acupuncture with polydioxanone (PDO) thread at EX-B2 L1 plus standard postoperative therapy or sham thread implantation acupuncture without thread insertion plus the same standard therapy. Pain intensity will be assessed using the Visual Analogue Scale (VAS) and quality of life with the Short-Form 36 (SF-36). The study seeks to determine whether thread implantation acupuncture provides additional analgesic and quality-of-life benefits beyond standard postoperative care.
Detailed description
Laparoscopic donor nephrectomy is the preferred technique for kidney donation due to its minimally invasive nature and faster recovery. However, postoperative pain and decreased quality of life remain significant issues. Excessive reliance on pharmacological analgesia can lead to adverse effects such as hepatotoxicity and gastrointestinal symptoms.
Thread implantation acupuncture involves inserting a biodegradable polydioxanone (PDO) thread into acupuncture points to provide prolonged stimulation. The EX-B2 (L1) point has been shown to modulate lumbar innervation and may help reduce nociceptive signaling associated with postoperative pain.
This double-blind randomized controlled trial compares the analgesic and quality-of-life outcomes between patients receiving thread implantation acupuncture at EX-B2 (L1) plus standard therapy and those receiving sham thread implantation acupuncture plus standard therapy. Pain intensity (VAS) will be measured pre-intervention (Day 0), then at postoperative Days 1, 2, 3, and 14. Quality of life (SF-36) will be evaluated at Day 0 and Day 14. The results are expected to strengthen evidence for thread implantation acupuncture as an adjunctive therapy for acute postoperative pain management and recovery after laparoscopic donor nephrectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention group will receive thread implantation acupuncture, while the control group will receive sham thread implantation acupuncture.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Thread implantation acupunctureThread implantation acupuncture |
| Control Group | Sham comparator | Device: Sham thread implantation acupunctureSham thread implantation acupuncture |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Living kidney donors scheduled to undergo laparoscopic living donor nephrectomy.
- Aged 21-60 years.
- Willing to participate and able to sign written informed consent
Key exclusion criteria (10 listed)
- Hypersensitivity to thread-embedding acupuncture (TEA).
- History of keloid formation or tendency to develop keloids.
- Skin disorders at or near the planned TEA insertion sites.
- Neurological abnormalities or lower-limb deficits on physical examination.
- History of spinal surgery or scheduled for spinal surgery within the next 7 months.
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 |
|---|---|---|
| Thread implantation acupunctureThread implantation acupuncture performed bilaterally at EX-B2 (L1) using polydioxanone (PDO) thread (26G × 38 mm) inserted subcutaneously to a depth of approximately 1-1.5 cm. The procedure is conducted once under aseptic conditions before surgery, combined with standard postoperative analgesic therapy. | Device | Intervention Group |
| Sham thread implantation acupunctureSham thread embedding acupuncture performed bilaterally at EX-B2 (L1) using a blunt needle without thread insertion, mimicking the procedure but without embedding material. Participants also receive standard postoperative therapy. | Device | Control Group |
Primary outcome
Change in Pain Intensity (Visual Analogue Scale)
Time frame: From baseline to postoperative Day 14
Visual Analogue Scale (0-100 mm) measured at Day 0 (baseline), Day 1, 2, 3, and 14 post-surgery.
3 secondary outcomes
Change in Quality of Life (Short Form-36)
Time frame: Baseline and Day 14.
Analgesic Use
Time frame: Day 0-14.
Adverse Events Adverse Events Adverse Events
Time frame: Up to Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
KEPK FKUI-RSCM principal investigator
The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thread implantation acupuncture in people with Postoperative Pain and Kidney Transplant; Complications, 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 8 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (Visual Analogue Scale) (time frame: From baseline to postoperative Day 14). 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 8 Jan 2026.