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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pruritus, Kidney Failure, Chronic

Intervention / Treatment
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* Device: Laser acupuncture (Olympic)
* Device: Sham Laser acupuncture (Olympic)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laser acupuncture<br>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)<br>* Physiolaser Olympic laser acupuncture device (50mW, 655nm)<br>Device: Sham Laser acupuncture (Olympic)<br>* Physiolaser Olympic laser acupuncture device (Low dose of laser energy: 5mW, 655nm)<br>|
| Sham Comparator: sham laser acupuncture<br>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)<br>* Physiolaser Olympic laser acupuncture device (50mW, 655nm)<br>Device: Sham Laser acupuncture (Olympic)<br>* Physiolaser Olympic laser acupuncture device (Low dose of laser energy: 5mW, 655nm)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, laser, uremic pruritus, randomized clinical trial