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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Kidney Transplant; Complications
• Intervention / Treatment: Device: Thread implantation acupuncture; Device: Sham thread implantation acupuncture

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Dki Jakarta
    • Jakarta Pusat, Dki Jakarta, Indonesia, 10430
      • Universitas Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Thread implantation acupuncture	Device: Thread implantation acupuncture; 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 Comparator: Control Group; Sham thread implantation acupuncture	Device: Sham thread implantation acupuncture; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic Use	Total postoperative paracetamol dose used within 14 days.	Day 0-14.
Adverse Events Adverse Events Adverse Events	Frequency and type of adverse reactions (pain, bruising, infection, thread extrusion).	Up to Day 14
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.	Baseline and Day 14.

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: KEPK FKUI-RSCM, The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2025
• Primary Completion (Actual): November 10, 2025
• Study Completion (Actual): December 10, 2025

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Estimated): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: 24-12-1864

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