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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
Physiolaser Olympic laser acupuncture device (50mW, 655nm)
Physiolaser Olympic laser acupuncture device (Low dose of laser energy: 5mW, 655nm)
China Medical University Hospital
Taichung, Taichung, Taiwan
RECRUITINGPruritus 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.
Time frame: 20 weeks
Short-Form-36 Health Survey (SF-36)
SF-36 questionnaire will perform in the begin, 4th, 8th, 12th, 16th and 20th week.
Time frame: 20 weeks
Dermatology Life Quality Index (DLQI)
DLQI questionnaire will perform in the begin, 4th, 8th, 12th, 16th and 20th week.
Time frame: 20 weeks
The 5-D itch scale
The 5-D itch scale will perform in the begin, 4th, 8th, 12th, 16th and 20th week.
Time frame: 20 weeks
The Pittsburgh Sleep Quality Index; PSQI
PSQI will perform in the begin, 4th, 8th, 12th, 16th and 20th week.
Time frame: 20 weeks
Beck Depression Inventory, BDI
BDI will perform in the begin, 4th, 8th, 12th, 16th and 20th week.
Time frame: 20 weeks
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