Short-term Comparative Clinical Outcomes of Acupuncture and Phototherapy in Chronic Generalized Pruritus: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Visual Analogue Scale for Pruritus
研究概览
简要总结
Chronic pruritus is a common and challenging condition with limited effective treatment options. This prospective, randomized comparative study aimed to evaluate the short-term clinical efficacy and safety of acupuncture compared with narrow-band UVB phototherapy in patients with chronic generalized pruritus. A total of 90 adult patients were enrolled and treated for one month. Pruritus severity was assessed using the Visual Analogue Scale (VAS) and Investigator's Global Assessment (IGA) at baseline and after treatment.
详细描述
This prospective comparative study included 90 adult patients diagnosed with chronic generalized pruritus. Participants were randomized into two parallel groups: an acupuncture group (n=50) and a narrow-band UVB phototherapy group (n=40). Acupuncture was administered twice weekly for one month (eight sessions total) using standardized acupuncture points in accordance with STRICTA recommendations. Phototherapy was administered three times weekly for one month. The primary outcomes were changes in pruritus severity measured by VAS and IGA at baseline and at one month. Safety and comparative short-term efficacy were evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Clinical diagnosis of chronic generalized pruritus lasting longer than 6 weeks
- •Ability to understand the study procedures and provide written informed consent
- •Willingness to comply with the study protocol and attend scheduled visits
排除标准
- •(Acupuncture Group):
- •Pregnancy or breastfeeding
- •Bleeding disorders or use of anticoagulant therapy
- •Skin diseases or lesions impairing skin integrity at acupuncture application sites
- •Advanced hypertension or heart failure
- •Exclusion Criteria (Phototherapy Group):
- •Pregnancy or breastfeeding
- •Sun hypersensitivity or photodermatoses
- •Skin diseases triggered by sunlight
- •Claustrophobia
- •Advanced hypertension or heart failure
研究组 & 干预措施
Acupunture
Patients received acupuncture treatment twice weekly for one month (total of eight sessions). Sterile disposable steel needles (0.25 × 25 mm) were applied at standardized acupuncture points: LI11 (Quchi), LI4 (Hegu), ST36 (Zusanli), SP4 (Gongsun), SP6 (Sanyinjiao), SP10 (Xuehai), GB31 (Fengshi), LU10 (Yuji), PC6 (Neiguan), and DU20 (Baihui). Each session lasted 30 minutes, with manual stimulation performed every 10 minutes until the Deqi sensation was achieved.
干预措施: Sterile disposable acupuncture needles (Device)
Narrow-band UVB Phototherapy
Patients underwent narrow-band UVB phototherapy three times per week for one month. Treatment doses ranged between 3.6 and 5.34 J/cm², adjusted according to individual skin type.
干预措施: Narrow Band UVB Phototherapy Unit (Device)
结局指标
主要结局
Change in Visual Analogue Scale for Pruritus
时间窗: Baseline to 1 month
The Visual Analogue Scale (VAS) is a patient-reported scale used to assess pruritus severity. Unit of Measure: Units on a Scale Scale Description : Visual Analogue Scale ranges from 0 to 10, where 0 indicates no pruritus and 10 indicates the worst imaginable pruritus. Higher scores indicate worse pruritus severity.
次要结局
- Change in Investigator's Global Assessment for Chronic Pruritus(Baseline to 1 month)
研究者
Nermin Karaosmanoğlu
Associate Professor of Dermatology, MD
Ankara Education and Research Hospital