NCT02432508

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 4, 2015

Status Verified

April 1, 2015

Enrollment Period

2.2 years

First QC Date

January 18, 2015

Last Update Submit

May 1, 2015

Conditions

PruritusKidney Failure, Chronic

Keywords

acupuncturelaseruremic pruritusrandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    20 weeks

Secondary Outcomes (5)

  • Short-Form-36 Health Survey (SF-36)

    20 weeks

  • Dermatology Life Quality Index (DLQI)

    20 weeks

  • The 5-D itch scale

    20 weeks

  • The Pittsburgh Sleep Quality Index; PSQI

    20 weeks

  • Beck Depression Inventory, BDI

    20 weeks

Study Arms (2)

laser acupuncture

ACTIVE COMPARATOR

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)Device: Sham Laser acupuncture (Olympic)

sham laser acupuncture

SHAM COMPARATOR

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)Device: Sham Laser acupuncture (Olympic)

Interventions

Laser acupuncture (Olympic)DEVICE

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

laser acupuncturesham laser acupuncture
Sham Laser acupuncture (Olympic)DEVICE

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

laser acupuncturesham laser acupuncture

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, Taichung, 420, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33283264DERIVED

MeSH Terms

Conditions

PruritusKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic Processes

Study Officials

  • Chang Chiz-Tzung, Ph.D.

    School of Medicine, China Medical University

    STUDY CHAIR

Central Study Contacts

Chang Chiz-Tzung, Ph.D.

CONTACT

886 0422052121D19863@mail.cmuh.org.tw

Chen Hung-Chih, M.D.

CONTACT

886 0422052121D18797@mail.cmuh.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2015

First Posted

May 4, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 4, 2015

Record last verified: 2015-04

Locations

TW(1)