Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laser acupuncture | Active Comparator | 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 Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser acupuncture (Olympic) | Device | Physiolaser Olympic laser acupuncture device (50mW, 655nm) |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang Chiz-Tzung, Ph.D. | Contact | 886 0422052121 | 3483 | D19863@mail.cmuh.org.tw |
| Chen Hung-Chih, M.D. | Contact | 886 0422052121 | 3483 | D18797@mail.cmuh.org.tw |
| Name | Affiliation | Role |
|---|---|---|
| Chang Chiz-Tzung, Ph.D. | School of Medicine, China Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Recruiting | Taichung | Taichung | 420 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33283264 | Derived | Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011537 | Pruritus |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham Laser acupuncture (Olympic) | Device | Physiolaser Olympic laser acupuncture device (Low dose of laser energy: 5mW, 655nm) |
|
| 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 |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |