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

Primary Purpose

Pruritus, Kidney Failure, Chronic

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Laser acupuncture (Olympic)
Sham Laser acupuncture (Olympic)
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pruritus focused on measuring acupuncture, laser, uremic pruritus, randomized clinical trial

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

laser acupuncture

sham laser acupuncture

Arm 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).

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).

Outcomes

Primary Outcome Measures

Pruritus Visual Analogue Scale
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

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

Full Information

First Posted
January 18, 2015
Last Updated
May 1, 2015
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02432508
Brief Title
Efficacy of Laser Acupuncture on Pruritus in Patients With Chronic Kidney Disease Undergoing Hemodialysis
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 Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus, Kidney Failure, Chronic
Keywords
acupuncture, laser, uremic pruritus, randomized clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laser acupuncture
Arm Type
Active Comparator
Arm 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).
Arm Title
sham laser acupuncture
Arm Type
Sham Comparator
Arm 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).
Intervention Type
Device
Intervention Name(s)
Laser acupuncture (Olympic)
Intervention Description
Physiolaser Olympic laser acupuncture device (50mW, 655nm)
Intervention Type
Device
Intervention Name(s)
Sham Laser acupuncture (Olympic)
Intervention Description
Physiolaser Olympic laser acupuncture device (Low dose of laser energy: 5mW, 655nm)
Primary Outcome Measure Information:
Title
Pruritus Visual Analogue Scale
Description
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.
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Short-Form-36 Health Survey (SF-36)
Description
SF-36 questionnaire will perform in the begin, 4th, 8th, 12th, 16th and 20th week.
Time Frame
20 weeks
Title
Dermatology Life Quality Index (DLQI)
Description
DLQI questionnaire will perform in the begin, 4th, 8th, 12th, 16th and 20th week.
Time Frame
20 weeks
Title
The 5-D itch scale
Description
The 5-D itch scale will perform in the begin, 4th, 8th, 12th, 16th and 20th week.
Time Frame
20 weeks
Title
The Pittsburgh Sleep Quality Index; PSQI
Description
PSQI will perform in the begin, 4th, 8th, 12th, 16th and 20th week.
Time Frame
20 weeks
Title
Beck Depression Inventory, BDI
Description
BDI will perform in the begin, 4th, 8th, 12th, 16th and 20th week.
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chang Chiz-Tzung, Ph.D.
Phone
886 0422052121
Ext
3483
Email
D19863@mail.cmuh.org.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Hung-Chih, M.D.
Phone
886 0422052121
Ext
3483
Email
D18797@mail.cmuh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Chiz-Tzung, Ph.D.
Organizational Affiliation
School of Medicine, China Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
420
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Chiz-Tzung, Ph.D.
Phone
886 0422052121
Ext
3483
Email
D19863@mail.cmuh.org.tw

12. IPD Sharing Statement

Citations:
PubMed Identifier
33283264
Citation
Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
Results Reference
derived

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

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