Evaluation of the Efficacy of Laser Acupuncture on Uremic Pruritus

NCT06875115 | Completed Results

• 1 other identifier: B11301036
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Sixty patients were randomly assigned to either the experimental group (n=30) receiving laser acupuncture or the control group (n=30) receiving sham laser acupuncture. Treatment sessions were conducted during dialysis sessions. The experimental group received laser acupuncture at Xuehai, Quchi, and Bai Chongwo acupoints three times per week for four weeks. The control group received sham laser acupuncture at the same acupoints. The 5-D Pruritus Scale and DLQI were used to assess pruritus severity before and after the intervention.

Conditions

Uremia

Keywords

uremia

Outcome Measures

Primary Outcomes (1)

• Title: Evaluation of the Efficacy of Laser Acupuncture on Ureimc Pruritus

  The severity of uremic pruritus was assessed using the 5-D Itch Scale, a validated instrument that measures itch duration, degree, direction, disability, and distribution. The total score ranges from 5 to 25, with higher scores indicating worse pruritus. Measurements were taken at baseline and at week 4 after completion of the laser acupuncture or sham intervention.

  A 4-week timeframe from enrollment to treatment completion.

Study Arms (2)

laser acupuncture on acupoint

ACTIVE COMPARATOR

The experimental group is a powered, functional laser device,

Device: laser acupuncture

shame laser on acupoints

PLACEBO COMPARATOR

the control group is a non-functional laser device that does not emit light and has no therapeutic effect.

Device: laser acupuncture

Interventions

laser acupuncture DEVICE

laser acupuncture on acupoints

laser acupuncture on acupoint; shame laser on acupoints

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 20 years.
• Intact parathyroid hormone (iPTH) levels \< 68 pg/mL (patients with -thyroidectomy excluded).
• Urea nitrogen (BUN) clearance rate (Kt/V) ≥ 1.2 at each dialysis session.
• Serum phosphate levels \< 5.5 mg/dL.
• Receiving hemodialysis three times weekly for at least three consecutive months.
• No history of acute illnesses like infections or cardiovascular disease.
• Avoiding a high-phosphorus diet.
• Adjusting dialysate calcium concentration to 8.6-10 mg/dL.
• Replacing the artificial kidney or increasing dialysis blood flow

You may not qualify if:

• Pregnant or nursing.
• History of photosensitivity.
• Recent use of systemic or local medications for pruritus (e.g., immunosuppressants, opioid agonists/antagonists, glucocorticoids, antihistamines, ultraviolet B therapy).
• Hepatobiliary dysfunction based on medical history and liver function tests.
• Malignancies.
• Other itchy skin conditions diagnosed by a dermatologist.
• Wounds near acupuncture points, contraindicating laser acupuncture

Sponsors & Collaborators

• Dalin Tzu Chi General Hospital: lead

Study Sites (1)

Dalin Tzu Chi Hospital

Dalin, Chiayi, 622, Taiwan

Location

MeSH Terms

Conditions

Uremia

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

This study was conducted in a single center with a relatively small sample size, which may limit the generalizability of the findings. The follow-up period was short (4 weeks), and longer-term effects of laser acupuncture on uremic pruritus could not be evaluated. The study population consisted of stable hemodialysis patients, and results may not apply to other patient groups.

Results Point of Contact

• Title: Ying-Hsu Juan, M.D. Principal Investigator
• Organization: Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

ddjjaa@tcts.seed.net.tw

+886-5-2648000

Study Officials

• Ying-HSU Juan, doctor

  doctor

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: March 13, 2025
• Study Start: April 9, 2024
• Primary Completion: May 11, 2024
• Study Completion: April 11, 2025
• Last Updated: December 24, 2025
• Results First Posted: December 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)