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

Not Applicable

• Conditions: Kidney Failure, Chronic; Pruritus
• Interventions: Device: Laser acupuncture (Olympic); Device: Sham Laser acupuncture (Olympic)

• Registration Number: NCT02432508
• Lead Sponsor: China Medical University Hospital

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-01-18
• Status Verified: 2015-04
• Study First Submitted QC: 2015-05-01
• Last Update Submitted: 2015-05-01
• Study First Posted: 2015-05-04
• Last Update Posted: 2015-05-04
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
laser acupuncture	Sham Laser acupuncture (Olympic)	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).
sham laser acupuncture	Sham Laser acupuncture (Olympic)	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).
sham laser acupuncture	Laser acupuncture (Olympic)	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).
laser acupuncture	Laser acupuncture (Olympic)	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).

Primary Outcome Measures

Name	Time	Method
Pruritus Visual Analogue Scale	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

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

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan