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

May 1, 2015 updated by: China Medical University Hospital

Efficacy of Laser Acupuncture on Pruritus in Patients With Chronic Kidney Disease Undergoing Hemodialysis: A Multiple Centers, Randomized, Assessor- and Participant-blind, Controlled, Cross-over Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 420
        • Recruiting
        • China Medical University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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).
Device: Laser acupuncture (Olympic)
Physiolaser Olympic laser acupuncture device (50mW, 655nm)
Device: Sham Laser acupuncture (Olympic)
Physiolaser Olympic laser acupuncture device (Low dose of laser energy: 5mW, 655nm)
Sham Comparator: 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).
Device: Laser acupuncture (Olympic)
Physiolaser Olympic laser acupuncture device (50mW, 655nm)
Device: Sham Laser acupuncture (Olympic)
Physiolaser Olympic laser acupuncture device (Low dose of laser energy: 5mW, 655nm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pruritus Visual Analogue Scale
Time Frame: 20 weeks

We plan to enroll 200 volunteer patients with uremic pruritus. After the waiting period (4weeks), the patients will be randomized to laser acupuncture and sham laser acupuncture group (4weeks). 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 will perform in the last 4 weeks.

Pruritus Visual Aaalogue Scale questionnaire will perform on each visit of hemodialysis.
20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-Form-36 Health Survey (SF-36)
Time Frame: 20 weeks
SF-36 questionnaire will perform in the begin, 4th, 8th, 12th, 16th and 20th week.
20 weeks
Dermatology Life Quality Index (DLQI)
Time Frame: 20 weeks
DLQI questionnaire will perform in the begin, 4th, 8th, 12th, 16th and 20th week.
20 weeks
The 5-D itch scale
Time Frame: 20 weeks
The 5-D itch scale will perform in the begin, 4th, 8th, 12th, 16th and 20th week.
20 weeks
The Pittsburgh Sleep Quality Index; PSQI
Time Frame: 20 weeks
PSQI will perform in the begin, 4th, 8th, 12th, 16th and 20th week.
20 weeks
Beck Depression Inventory, BDI
Time Frame: 20 weeks
BDI will perform in the begin, 4th, 8th, 12th, 16th and 20th week.
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Study Chair: Chang Chiz-Tzung, Ph.D., School of Medicine, China Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

January 18, 2015

First Submitted That Met QC Criteria

May 1, 2015

First Posted (Estimate)

May 4, 2015

Study Record Updates

Last Update Posted (Estimate)

May 4, 2015

Last Update Submitted That Met QC Criteria

May 1, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-3-2-A/CMUH103-REC2-112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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