Kidney Failure, Chronic, Pruritus
Conditions
Keywords
acupuncture, laser, uremic pruritus, randomized clinical trial
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.
Interventions
DEVICELaser acupuncture (Olympic)
Physiolaser Olympic laser acupuncture device (50mW, 655nm)
DEVICESham Laser acupuncture (Olympic)
Physiolaser Olympic laser acupuncture device (Low dose of laser energy: 5mW, 655nm)
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Short-Form-36 Health Survey (SF-36) | 20 weeks | SF-36 questionnaire will perform in the begin, 4th, 8th, 12th, 16th and 20th week. |
| Dermatology Life Quality Index (DLQI) | 20 weeks | DLQI 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. |
| The Pittsburgh Sleep Quality Index; PSQI | 20 weeks | PSQI 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. |
Countries
Taiwan
Contacts
Primary ContactChang Chiz-Tzung, Ph.D.
Backup ContactChen Hung-Chih, M.D.
Outcome results
None listed