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

Kidney Failure, Chronic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02432508
• Other study ID #: A-3-2-A/CMUH103-REC2-112
• Status: Recruiting
• Phase: N/A
• First received: January 18, 2015
• Last updated: May 1, 2015
• Start date: October 2014
• Est. completion date: December 2016

Study information

• Verified date: April 2015
• Source: China Medical University Hospital
• Contact: Chang Chiz-Tzung, Ph.D.
• Phone: 886 0422052121
• Email: D19863[@]mail.cmuh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: National Health Research Institutes
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Failure, Chronic
• Pruritus
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Device:
• Laser acupuncture (Olympic)
Physiolaser Olympic laser acupuncture device (50mW, 655nm)
• Sham Laser acupuncture (Olympic)
Physiolaser Olympic laser acupuncture device (Low dose of laser energy: 5mW, 655nm)

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Short-Form-36 Health Survey (SF-36)	SF-36 questionnaire will perform in the begin, 4th, 8th, 12th, 16th and 20th week.	20 weeks	No
Secondary	Dermatology Life Quality Index (DLQI)	DLQI questionnaire will perform in the begin, 4th, 8th, 12th, 16th and 20th week.	20 weeks	No
Secondary	The 5-D itch scale	The 5-D itch scale will perform in the begin, 4th, 8th, 12th, 16th and 20th week.	20 weeks	No
Secondary	The Pittsburgh Sleep Quality Index; PSQI	PSQI will perform in the begin, 4th, 8th, 12th, 16th and 20th week.	20 weeks	No
Secondary	Beck Depression Inventory, BDI	BDI will perform in the begin, 4th, 8th, 12th, 16th and 20th week.	20 weeks	No