Chronic Kidney Disease Requiring Chronic Dialysis
Conditions
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
Interventions
DEVICEThe 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).
DEVICEThe 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.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The participant and outcomes assessor will be blinded to group allocation.
Intervention model description
The press needle, antihistamine, and moisturizer therapy will be designted as the intervention group, while the sham press needle, antihistamine, and moisturizer therapy will be designated as the control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Indonesia
Outcome results
None listed