Efficacy of Laser Acupuncture on Pruritus in Patients With Chronic Kidney Disease Undergoing Hemodialysis

China Medical University

Status: Unknown

Conditions: Kidney Failure, Chronic; Pruritus

Treatments: Device: Sham Laser acupuncture (Olympic); Device: Laser acupuncture (Olympic)

Study type: Interventional

Funder types: Other

Identifiers

NCT02432508

A-3-2-A/CMUH103-REC2-112

Details and patient eligibility

About

Uremic pruritus is a clinically significant symptom which imposes heavy impact on the quality of life of patients with chronic kidney disease undergoing hemodialysis. In order to investigate the clinical efficacy and mechanism, the investigators designed a multiple centers, randomized, assessor- and participant-blind, controlled, cross-over clinical trial. This trial will be conducted at Taichung branch, Feng-yuan branch and the Eastern branch of CMUH.

Full description

We plan to enroll 200 volunteer patients with uremic pruritus. After the waiting period (as the waiting list group), you will be randomized to laser acupuncture and sham laser acupuncture group. Each group will include 100 patients and given intervention according to their hemodialysis frequency, i.e., BIW or TIW. The intervention will then be crossed over to the other one after 4 week of wash-our period. Outcome measurement includes questionnaires, biochemistry analysis, instrumental analysis and medication score.

Enrollment: 200 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age>20y/o, ESRD patient, pruritus symptoms persist longer than 4 weeks

Exclusion criteria

• immunosupression agents use, undergo chemotherapy
• drug abuser
• pregnancy women
• patient with psychiological disorder
• arrhythemia, pacemaker device use
• local skin infection over laser acupuncture site
• patient allergy to laser acupuncture treament

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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200 participants in 2 patient groups

laser acupuncture

Active Comparator group

Description:

One hundreds of hemodialysis patients include and give intervention with laser acupuncture (50mW) for 4 weeks. After 4 weeks of wash out period, these patients cross over to shame laser acupuncture treatment (5mW).

Treatment:

Device: Laser acupuncture (Olympic)

Device: Sham Laser acupuncture (Olympic)

sham laser acupuncture

Sham Comparator group

Description:

One hundreds of hemodialysis patients include and give intervention with sham laser acupuncture (5mW) for 4 weeks. After 4 weeks of wash out period, these patients cross over to laser acupuncture treatment (50mW).

Treatment:

Device: Laser acupuncture (Olympic)

Device: Sham Laser acupuncture (Olympic)