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

University of Indonesia (UI)

Status: Completed

Conditions: Chronic Kidney Disease Requiring Chronic Dialysis

Treatments: Device: The press needle, antihistamine, and moisturizer therapy; Device: The sham press needle, antihistamine and moisturizer therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07030465

25-06-0788

Details and patient eligibility

About

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

Enrollment: 38 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Intervention Group

Experimental group

Description:

The press needle, antihistamine and moisturizer therapy

Treatment:

Device: The press needle, antihistamine, and moisturizer therapy

Control Group

Sham Comparator group

Description:

The sham press needle, antihistamine and moisturizer therapy

Treatment:

Device: The sham press needle, antihistamine and moisturizer therapy