Thread Embedding Acupuncture vs Sham on Acute Pain and Quality of Life After Laparoscopic Nephrectomy of Living Donor

NCT07243301 | Completed

• 1 other identifier: 24-12-1864
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postoperative Pain; Kidney Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to postoperative Day 14

Secondary Outcomes (3)

• Change in Quality of Life (Short Form-36)

  Baseline and Day 14.

• Analgesic Use

  Day 0-14.

• Adverse Events Adverse Events Adverse Events

  Up to Day 14

Study Arms (2)

Intervention Group

EXPERIMENTAL

Thread implantation acupuncture

Device: Thread implantation acupuncture

Control Group

SHAM COMPARATOR

Sham thread implantation acupuncture

Device: Sham thread implantation acupuncture

Interventions

Thread implantation acupuncture DEVICE

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.

Intervention Group

Sham thread implantation acupuncture DEVICE

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.

Control Group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Living kidney donors scheduled to undergo laparoscopic living donor nephrectomy.
• Aged 21-60 years.
• Willing to participate and able to sign written informed consent

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, Dki Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• KEPK FKUI-RSCM

  The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding will be applied to participants and outcome assessors. Group allocation will not be disclosed to them to minimize assessment bias.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The intervention group will receive thread implantation acupuncture, while the control group will receive sham thread implantation acupuncture.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: February 10, 2025
• Primary Completion: November 10, 2025
• Study Completion: December 10, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)