Image

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

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

Recruiting
18-65 years
All
Phase N/A

Powered by AI

Overview

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

Eligibility

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 details
    Chronic Kidney Disease Requiring Chronic Dialysis

NCT07030465

Indonesia University

19 August 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.