Evaluation of the Efficacy of Laser Acupuncture on Uremic Pruritus-Randomized Controlled Trial Double Blind
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Title: Evaluation of the Efficacy of Laser Acupuncture on Ureimc Pruritus
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
laser acupuncture on acupoint
The experimental group is a powered, functional laser device,
Intervention: laser acupuncture (Device)
shame laser on acupoints
the control group is a non-functional laser device that does not emit light and has no therapeutic effect.
Intervention: laser acupuncture (Device)
Outcomes
Primary Outcomes
Title: Evaluation of the Efficacy of Laser Acupuncture on Ureimc Pruritus
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported