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NCT Number: NCT07030465

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

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

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Key information

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

The press needle, antihistamine, and moisturizer therapy

Device

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).

The sham press needle, antihistamine and moisturizer therapy

Device

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.

Primary outcomes

  1. 5-D Pruritus Scale

    Time frame: 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.

  2. Adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2025
Registry last updated
Dec 9, 2025

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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