Uremia
Conditions
Keywords
uremia
Brief summary
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.
Detailed description
The subjects were divided into two groups to investigate whether laser acupuncture can improve uremic pruritus.
Interventions
DEVICElaser acupuncture
laser acupuncture on acupoints
Sponsors
Dalin Tzu Chi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 20 years. * Intact parathyroid hormone (iPTH) levels \< 68 pg/mL (patients with -thyroidectomy excluded). * Urea nitrogen (BUN) clearance rate (Kt/V) ≥ 1.2 at each dialysis session. * Serum phosphate levels \< 5.5 mg/dL. * Receiving hemodialysis three times weekly for at least three consecutive months. * No history of acute illnesses like infections or cardiovascular disease. * Avoiding a high-phosphorus diet. * Adjusting dialysate calcium concentration to 8.6-10 mg/dL. * Replacing the artificial kidney or increasing dialysis blood flow
Exclusion criteria
* Pregnant or nursing. * History of photosensitivity. * Recent use of systemic or local medications for pruritus (e.g., immunosuppressants, opioid agonists/antagonists, glucocorticoids, antihistamines, ultraviolet B therapy). * Hepatobiliary dysfunction based on medical history and liver function tests. * Malignancies. * Other itchy skin conditions diagnosed by a dermatologist. * Wounds near acupuncture points, contraindicating laser acupuncture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Title: Evaluation of the Efficacy of Laser Acupuncture on Ureimc Pruritus | A 4-week timeframe from enrollment to treatment completion. | 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. |
Countries
Taiwan
Participant flow
Recruitment details
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.
Pre-assignment details
All 60 consented participants completed baseline assessment and proceeded to randomization without exclusions. No participants withdrew or were removed prior to group assignment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Laser Acupuncture | Total | Sham Laser |
|---|---|---|---|
| Age, Continuous | 59.20 years STANDARD_DEVIATION 11.52 | 58.24 years STANDARD_DEVIATION 12.02 | 57.27 years STANDARD_DEVIATION 12.39 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 30 Participants | 60 Participants | 30 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 16 Participants | 31 Participants | 15 Participants |
| Sex: Female, Male Male | 14 Participants | 29 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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.
Time frame: A 4-week timeframe from enrollment to treatment completion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Laser Acupuncture | Title: Evaluation of the Efficacy of Laser Acupuncture on Ureimc Pruritus | baesline | 18.13 points | Standard Deviation 3.71 |
| Laser Acupuncture | Title: Evaluation of the Efficacy of Laser Acupuncture on Ureimc Pruritus | Week 4 | 10.20 points | Standard Deviation 4.96 |
| Sham Laser | Title: Evaluation of the Efficacy of Laser Acupuncture on Ureimc Pruritus | baesline | 17.47 points | Standard Deviation 3.58 |
| Sham Laser | Title: Evaluation of the Efficacy of Laser Acupuncture on Ureimc Pruritus | Week 4 | 17.10 points | Standard Deviation 3.72 |
Comparison: Primary Outcome Analysisp-value: <0.05t-test, 1 sided