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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pruritus Kidney Failure, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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laser acupuncture

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).

Group Type ACTIVE_COMPARATOR

Laser acupuncture (Olympic)

Intervention Type DEVICE

Physiolaser Olympic laser acupuncture device (50mW, 655nm)

Sham Laser acupuncture (Olympic)

Intervention Type DEVICE

Physiolaser Olympic laser acupuncture device (Low dose of laser energy: 5mW, 655nm)

sham laser acupuncture

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).

Group Type SHAM_COMPARATOR

Laser acupuncture (Olympic)

Intervention Type DEVICE

Physiolaser Olympic laser acupuncture device (50mW, 655nm)

Sham Laser acupuncture (Olympic)

Intervention Type DEVICE

Physiolaser Olympic laser acupuncture device (Low dose of laser energy: 5mW, 655nm)

Interventions

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Laser acupuncture (Olympic)

Physiolaser Olympic laser acupuncture device (50mW, 655nm)

Intervention Type DEVICE

Sham Laser acupuncture (Olympic)

Physiolaser Olympic laser acupuncture device (Low dose of laser energy: 5mW, 655nm)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes