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Sixty patients were randomly assigned to either the experimental group (n=30) receiving laser acupuncture or the control group (n=30) receiving sham laser acupuncture. Treatment sessions were conducted during dialysis sessions. The experimental group received laser acupuncture at Xuehai, Quchi, and Bai Chongwo acupoints three times per week for four weeks. The control group received sham laser acupuncture at the same acupoints. The 5-D Pruritus Scale and DLQI were used to assess pruritus severity before and after the intervention.
The subjects were divided into two groups to investigate whether laser acupuncture can improve uremic pruritus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laser acupuncture on acupoint | Active Comparator | The experimental group is a powered, functional laser device, |
|
| shame laser on acupoints | Placebo Comparator | the control group is a non-functional laser device that does not emit light and has no therapeutic effect. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laser acupuncture | Device | laser acupuncture on acupoints |
|
| Measure | Description | Time Frame |
|---|---|---|
| Title: Evaluation of the Efficacy of Laser Acupuncture on Ureimc Pruritus | The severity of uremic pruritus was assessed using the 5-D Itch Scale, a validated instrument that measures itch duration, degree, direction, disability, and distribution. The total score ranges from 5 to 25, with higher scores indicating worse pruritus. Measurements were taken at baseline and at week 4 after completion of the laser acupuncture or sham intervention. | A 4-week timeframe from enrollment to treatment completion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ying-HSU Juan, doctor | doctor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dalin Tzu Chi Hospital | Dalin | Chiayi | 622 | Taiwan |
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All 60 consented participants completed baseline assessment and proceeded to randomization without exclusions. No participants withdrew or were removed prior to group assignment.
Participants were recruited from the hemodialysis center of Dalin Tzu Chi Hospital between January 2024 and December 2024. Eligible patients were screened based on inclusion/exclusion criteria during routine dialysis visits. Written informed consent was obtained prior to enrollment. A total of 60 participants met eligibility criteria and agreed to join the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Laser | Participants received sham laser acupuncture at the same acupoints (Quchi, Xuehai, Baichongwo) using identical device appearance and procedure, without active laser output. Frequency and duration matched the active group. |
| FG001 | Laser Acupuncture | Participants received low-level laser acupuncture delivered to Quchi (LI11), Xuehai (SP10), and Baichongwo (EX-LE4) bilaterally, three times per week for 4 weeks during routine hemodialysis sessions. Laser parameters were standardized for all treatments. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham Laser | Participants received sham laser acupuncture at the same acupoints (Quchi, Xuehai, Baichongwo) using identical device appearance and procedure, without active laser output. Frequency and duration matched the active group. |
| BG001 | Laser Acupuncture |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Title: Evaluation of the Efficacy of Laser Acupuncture on Ureimc Pruritus | The severity of uremic pruritus was assessed using the 5-D Itch Scale, a validated instrument that measures itch duration, degree, direction, disability, and distribution. The total score ranges from 5 to 25, with higher scores indicating worse pruritus. Measurements were taken at baseline and at week 4 after completion of the laser acupuncture or sham intervention. | Posted | Mean | Standard Deviation | points | A 4-week timeframe from enrollment to treatment completion. |
|
From baseline to week 4 during the intervention period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham Laser | Participants received sham laser acupuncture at Quchi (LI11), Xuehai (SP10), and Baichongwo (EX-LE4) using a device with no laser output. |
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This study was conducted in a single center with a relatively small sample size, which may limit the generalizability of the findings. The follow-up period was short (4 weeks), and longer-term effects of laser acupuncture on uremic pruritus could not be evaluated. The study population consisted of stable hemodialysis patients, and results may not apply to other patient groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ying-Hsu Juan, M.D. Principal Investigator | Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | +886-5-2648000 | ddjjaa@tcts.seed.net.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2025 | Dec 20, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014511 | Uremia |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Participants received low-level laser acupuncture delivered to Quchi (LI11), Xuehai (SP10), and Baichongwo (EX-LE4) bilaterally, three times per week for 4 weeks during routine hemodialysis sessions. Laser parameters were standardized for all treatments. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
Participants received sham laser acupuncture at the same acupoints with an inactive laser device twice weekly for 4 weeks.
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Laser Acupuncture | Participants received active laser acupuncture at Quchi (LI11), Xuehai (SP10), and Baichongwo (EX-LE4) using a low-level laser device delivering therapeutic output during each session. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |