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

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ClinicalTrials.gov Identifier: NCT02432508
Recruitment Status : Unknown
Verified April 2015 by China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : May 4, 2015
Last Update Posted : May 4, 2015
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pruritus Kidney Failure, Chronic Device: Laser acupuncture (Olympic) Device: Sham Laser acupuncture (Olympic) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

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Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. Dermatology Life Quality Index (DLQI) [ Time Frame: 20 weeks ]
    DLQI questionnaire will perform in the begin, 4th, 8th, 12th, 16th and 20th week.

  3. 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.

  4. The Pittsburgh Sleep Quality Index; PSQI [ Time Frame: 20 weeks ]
    PSQI will perform in the begin, 4th, 8th, 12th, 16th and 20th week.

  5. Beck Depression Inventory, BDI [ Time Frame: 20 weeks ]
    BDI will perform in the begin, 4th, 8th, 12th, 16th and 20th week.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432508


Contacts
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Contact: Chang Chiz-Tzung, Ph.D. 886 0422052121 ext 3483 D19863@mail.cmuh.org.tw
Contact: Chen Hung-Chih, M.D. 886 0422052121 ext 3483 D18797@mail.cmuh.org.tw

Locations
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Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 420
Contact: Chang Chiz-Tzung, Ph.D.    886 0422052121 ext 3483    D19863@mail.cmuh.org.tw   
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Study Chair: Chang Chiz-Tzung, Ph.D. School of Medicine, China Medical University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT02432508    
Other Study ID Numbers: A-3-2-A/CMUH103-REC2-112
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: May 4, 2015
Last Verified: April 2015
Keywords provided by China Medical University Hospital:
acupuncture
laser
uremic pruritus
randomized clinical trial
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
 Pruritus
Urologic Diseases
Skin Diseases
Skin Manifestations