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

University of Indonesia (UI)

Status: Completed

Conditions: Postoperative Pain; Kidney Transplant; Complications

Treatments: Device: Thread implantation acupuncture; Device: Sham thread implantation acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT07243301

24-12-1864

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Thread implantation acupuncture

Treatment:

Device: Thread implantation acupuncture

Control Group

Sham Comparator group

Description:

Sham thread implantation acupuncture

Treatment:

Device: Sham thread implantation acupuncture