Evaluation of the Efficacy of Laser Acupuncture on Uremic Pruritus-Randomized Controlled Trial Double Blind
Phase: NA
Conditions: Uremia
Sponsor: Dalin Tzu Chi General Hospital

Study Protocol and Statistical Analysis Plan 
Official Title: 
Evaluation of the Efficacy of Laser Acupuncture on Uremic Pruritus 
NCT Number: NCT06875115 
Unique Protocol ID: B11301036 
Document Date: 2025-12-14 
This document contains the complete study protocol and the statistical analysis plan (SAP) 
for submission to ClinicalTrials.gov. 
 
1. Study Objectives 
The primary objective of this study is to evaluate the efficacy of laser acupuncture in 
reducing uremic pruritus in patients undergoing hemodialysis. 
Secondary objectives include assessment of symptom severity, quality of life, and 
treatment safety. 
 
2. Study Design 
This is a prospective, randomized, controlled clinical study. Eligible participants will be 
allocated to intervention or control groups according to the study protocol. The study 
duration and assessment schedule are predefined. 
 
3. Participants 
Inclusion criteria include adult patients undergoing maintenance hemodialysis with 
clinically significant uremic pruritus. 
Exclusion criteria include severe comorbid conditions or contraindications to laser 
acupuncture. 
 

4. Interventions 
Participants in the intervention group will receive laser acupuncture at predefined 
acupoints according to a standardized protocol. 
The control group will receive usual care or sham treatment as specified. 
 
5. Outcome Measures 
The primary outcome is change in pruritus severity measured by validated scales. 
Secondary outcomes include quality-of-life measures and adverse events. 
 
6. Statistical Analysis Plan (SAP) 
6.1 Analysis Populations 
All randomized participants will be included in the intention-to-treat (ITT) analysis. A per-
protocol analysis may be conducted as a secondary analysis. 
 
6.2 Primary Outcome Analysis 
The primary outcome will be analyzed using appropriate statistical tests based on data 
distribution. Between-group comparisons will be performed to evaluate treatment effects. 
 
6.3 Secondary Outcome Analyses 
Secondary outcomes will be analyzed using suitable parametric or non-parametric 
methods. Repeated measures may be analyzed using appropriate models. 
 
6.4 Handling of Missing Data 

Missing data will be handled using appropriate statistical methods, such as multiple 
imputation or last observation carried forward, depending on the nature and extent of 
missingness. 
 
6.5 Significance Level and Statistical Software 
All statistical tests will be two-sided with a significance level of 0.05. Statistical analyses 
will be conducted using standard statistical software. 
 
7. Ethical Considerations 
The study will be conducted in accordance with ethical principles and has received 
approval from the appropriate institutional review board.