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NCT Number: NCT07243301

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

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.

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Key information

Conditions

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

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Indonesia

Jakarta Pusat, Dki Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Quality of Life (Short Form-36)

    Time frame: Baseline and Day 14.

    Short Form-36 questionnaire assessing eight domains of quality of life at Day 0 and Day 14.

  2. Analgesic Use

    Time frame: Day 0-14.

    Total postoperative paracetamol dose used within 14 days.

  3. Adverse Events Adverse Events Adverse Events

    Time frame: Up to Day 14

    Frequency and type of adverse reactions (pain, bruising, infection, thread extrusion).

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2025
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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