NCT07030465

Therapeutic Effects of Press Needle on 5-D Pruritus Scale in Hemodialysis Patients With Chronic Kidney Disease-Associated Pruritus

Comparison of the Therapeutic Effects of Press Needle and Sham Press Needle on 5-D Pruritus Scale in Hemodialysis Patients With Chronic Kidney Disease-Associated Pruritus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess whether press needle acupuncture (PN) is more effective than sham press needle (sham PN) in reducing pruritus in patients with chronic kidney disease-associated pruritus (CKDaP) undergoing hemodialysis. The main questions it aims to answer are: * Does PN, compared to sham PN, reduce pruritus severity as measured by 5-D Pruritus Scale after the 2nd, 4th, 6th, and 8th therapy sessions? * Does PN, compared to sham PN, maintain a superior reduction in pruritus severity four weeks after the final session? * Are there any side effects associated with PN or sham PN in CKDaP patients on hemodialysis? Participants will: * Be patients undergoing hemodialysis with confirmed CKDaP * Undergo cognitive screening with MMSE to ensure accurate self-reporting * Be randomly assigned to receive either PN (needle inserted) or sham PN (tape only) * Have PN or sham PN applied unilaterally to acupoints LI11, SP10, ST36, and SP6, replaced every 3-4 days over a 4-week period * Complete the 5-D Pruritus Scale questionnaire before intervention, after every 2 sessions (2nd, 4th, 6th, 8th), and 4 weeks post-treatment

Conditions

• Chronic Kidney Disease Requiring Chronic Dialysis

Interventions

Type	Name	Description
DEVICE	The press needle, antihistamine, and moisturizer therapy	Device: Press Needle (PN) PN is applied unilaterally on acupoints LI11, SP10, ST36, and SP6 alternately. It consists of an adhesive patch with a small sterile needle retained for 3-4 days before replacement. This procedure is repeated over a 4-week period. Needle sizes is 0.22 × 1.5 mm), and all procedures follow standard aseptic protocols. PN provides prolonged stimulation with cumulative effects in a minimally invasive manner. Participants continue their routine hemodialysis and conventional treatments for CKD-associated pruritus (CKDaP).
DEVICE	The sham press needle, antihistamine and moisturizer therapy	Sham PN uses adhesive patches without needles, applied to the same acupoints (LI11, SP10, ST36, and SP6) with the same retention schedule (3-4 days over 4 weeks) as the intervention group. All procedures, including placement and instructions, are performed identically to maintain blinding. There is no skin penetration or real acupoint stimulation. Participants continue their routine hemodialysis and conventional treatments for CKDaP.

Timeline

• Start date: 2025-08-01
• Primary completion: 2025-10-13
• Completion: 2025-10-13
• First posted: 2025-06-22
• Last updated: 2025-12-09

Locations

1 site across 1 country: Indonesia