Trial Outcomes & Findings for Evaluation of the Efficacy of Laser Acupuncture on Uremic Pruritus (NCT NCT06875115)

Last Updated: 2025-12-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

A 4-week timeframe from enrollment to treatment completion.

Results posted on

2025-12-24

Participant Flow

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.

All 60 consented participants completed baseline assessment and proceeded to randomization without exclusions. No participants withdrew or were removed prior to group assignment.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Efficacy of Laser Acupuncture on Uremic Pruritus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham Laser n=30 Participants 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.	Laser Acupuncture n=30 Participants 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.	Total n=60 Participants Total of all reporting groups
Age, Continuous	57.27 years STANDARD_DEVIATION 12.39 • n=30 Participants	59.20 years STANDARD_DEVIATION 11.52 • n=30 Participants	58.24 years STANDARD_DEVIATION 12.02 • n=60 Participants
Sex: Female, Male Female	15 Participants n=30 Participants	16 Participants n=30 Participants	31 Participants n=60 Participants
Sex: Female, Male Male	15 Participants n=30 Participants	14 Participants n=30 Participants	29 Participants n=60 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Asian	30 Participants n=30 Participants	30 Participants n=30 Participants	60 Participants n=60 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Black or African American	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) White	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants

PRIMARY outcome

Timeframe: A 4-week timeframe from enrollment to treatment completion.

Outcome measures

Outcome measures
Measure	Laser Acupuncture n=30 Participants Participants received laser acupuncture at Quchi (LI11), Xuehai (SP10), and Baichongwo (EX-LE4) twice weekly for 4 weeks.	Sham Laser n=30 Participants Participants received sham laser acupuncture at the same acupoints with an inactive laser device twice weekly for 4 weeks.
Title: Evaluation of the Efficacy of Laser Acupuncture on Ureimc Pruritus baesline	18.13 points Standard Deviation 3.71	17.47 points Standard Deviation 3.58
Title: Evaluation of the Efficacy of Laser Acupuncture on Ureimc Pruritus Week 4	10.20 points Standard Deviation 4.96	17.10 points Standard Deviation 3.72

Adverse Events

Sham Laser

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Laser Acupuncture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ying-Hsu Juan, M.D. Principal Investigator

Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Phone: +886-5-2648000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place