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Evaluation of the Efficacy of Laser Acupuncture on Uremic Pruritus

NCT ID: NCT06875115

Last Updated: 2025-12-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-09

Study Completion Date

2025-04-11

Brief Summary

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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.

Detailed Description

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The subjects were divided into two groups to investigate whether laser acupuncture can improve uremic pruritus.

Conditions

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Uremia

Keywords

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uremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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laser acupuncture on acupoint

The experimental group is a powered, functional laser device,

Group Type ACTIVE_COMPARATOR

laser acupuncture

Intervention Type DEVICE

laser acupuncture on acupoints

shame laser on acupoints

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

Group Type PLACEBO_COMPARATOR

laser acupuncture

Intervention Type DEVICE

laser acupuncture on acupoints

Interventions

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laser acupuncture

laser acupuncture on acupoints

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dalin Tzu Chi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ying-HSU Juan, doctor

Role: STUDY_CHAIR

doctor

Locations

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Dalin Tzu Chi Hospital

Dalin, Chiayi, Taiwan

Site Status

Countries

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Taiwan

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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B11301036

Identifier Type: -

Identifier Source: org_study_id