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

Not Applicable

Not yet recruiting

• Conditions: Chronic Kidney Disease Requiring Chronic Dialysis

• Registration Number: NCT07030465
• Lead Sponsor: Indonesia University

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-06-12
• Study First Posted: 2025-06-22
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-26
• Study Start: 2025-08-01
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Patients with CKD-associated pruritus (CKDaP) undergoing regular hemodialysis twice a week for at least 6 months and in a hemodynamically stable condition, who meet the criteria for moderate to severe pruritus based on the 5-D Pruritus Scale
• Subjects aged between 18 and 65 years.
• Subjects have not received acupuncture therapy for at least one month prior to the study.
• Subjects have good cognitive function as assessed by the MMSE.
• Subjects are willing to participate in the study according to the scheduled timeline and have signed the informed consent form.

Exclusion Criteria

• Subjects have malignancies or infectious lesions at the acupuncture points to be treated.
• Subjects have primary skin diseases such as allergic dermatitis, irritant contact dermatitis, neurodermatitis, or psoriasis.
• Subjects have a history of hypersensitivity reactions to previous acupuncture therapy (such as metal allergy, atopy, keloids, or other hypersensitivities).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
5-D Pruritus Scale	Baseline, after 2nd, 4th, 6th, and 8th treatment sessions, and 4 weeks post-treatment	Pruritus severity will be assessed using the validated 5-D Pruritus Scale, which evaluates five dimensions: duration, degree, direction, disability, and distribution. Scores range from 5 to 25, with higher scores indicating more severe pruritus.
Adverse events	After 2nd, 4th, 6th, and 8th treatment sessions, and 4 weeks post-treatment	Any adverse events related to the intervention, including pain, bleeding, skin irritation, or infection at the site of application, will be recorded and monitored.

Trial Locations

Locations (1)

Universitas Indonesia; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia