Effects of Acupuncture for Senile Pruritus: Study Protocol for a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change from baseline in Numeric Rating Scale (NRS) scores for average itching severity at week 6.
研究概览
简要总结
Senile pruritus (SP), characterized by idiopathic itching in individuals aged 60 years and older without primary skin lesions, significantly impacts sleep and quality of life. Effective alternative treatments are needed. Acupuncture has been suggested as a potential intervention to alleviate itching; however, its role in managing SP remains uncertain. This study aims to evaluate the effects and safety of acupuncture for SP. This single-centre, parallel, two-arm, randomized, sham-controlled trial will enroll 108 patients diagnosed with SP in a 1:1 ratio to either the acupuncture or sham acupuncture group. Participants, outcome assessors, and the statistician will be blinded. Treatment will consist of 18 sessions over 6 weeks. The primary outcome is change from baseline in the Numerical Rating Scale (NRS) score for average itching severity at week 6, assessed weekly via weekly diary of pruritus assessment. Secondary outcomes include changes in NRS score for maximum itching severity, daily episodes of itching, itchy area of body surface, overall dry skin score (ODS), the Dermatology Life Quality Index (DLQI), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and Patient Global Impression of Change (PGIC). Adverse events will be monitored throughout the study period. The intention-to-treat (ITT) population will include participants who complete baseline assessments and receive at least one treatment session.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patients meeting the eligibility criteria for SP will be randomly assigned to either the acupuncture or sham acupuncture groups in a 1:1 ratio. The randomization sequence was generated using the blockrand package in R software (version 4.1.1) and is detailed in the supplementary materials. The sequence will be enclosed in sealed, opaque, sequentially numbered envelopes, which will be opened after participants complete all baseline assessments. Allocation to the assigned group will be conducted by a research assistant who is not involved in treatment or outcome assessments. Participants, outcome assessors, and the statistician will be blinded to group assignments, ensuring unbiased evaluation. However, the practitioner administering the intervention will not be blinded.
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged between 60 and 80 years who meet diagnostic criteria for SP, with an average severity score of itching in the past week of ≥4 points on the Numerical Rating Scale (NRS), and who voluntarily provide written informed consent are eligible for inclusion.
排除标准
- •Participants will be excluded if they meet any of the following criteria:
- •Severe skin damage or infection;
- •Severe underlying diseases including cardiovascular diseases, hepatobiliary diseases, kidney diseases, hematologic diseases, autoimmune diseases, infectious diseases, severe malnutrition, or malignancies;
- •Mental illness, cognitive dysfunction, or language disorders;
- •Received acupuncture therapy for pruritus within the past month;
- •Have a history of drug abuse.
研究组 & 干预措施
Acupuncture group
Treatment will be administered by licensed practitioners with over five years of experience, in separate rooms to prevent patient interaction. The selected acupuncture points include LI11 , SP10, ST36, SP6, LR3, LI4, ST25, CV4, GV20, and superior GV29. Sterile disposable stainless-steel needles (0.3 mm×40 mm; Hwato brand, Suzhou Medical Appliance Factory, Suzhou, China) will be used. Patients will lie supine, and routine skin sterilization will be performed locally. Needles will be inserted at depths ranging from 10 to 30 mm at the designated acupuncture points. Each needle will be manually manipulated with lifting, thrusting, twirling, and rotating to elicit Deqi sensation (including soreness, numbness, distention, and heaviness). Needles will remain inserted for 30 minutes per session and manipulated three times, every 10 minutes. Acupuncture sessions will be conducted three times weekly over a six-week period.
干预措施: Acupuncture (Other)
Sham acupuncture group
Patients in the control group will undergo sham acupuncture using sterile disposable stainless-steel needles (0.3 mm×25 mm; Hwato brand, Suzhou Medical Appliance Factory, Suzhou, China). Needles will be inserted to depths of 2 to 3 mm at the same acupuncture points as in the acupuncture group. There will be no needle manipulation or attempt to induce Deqi sensation. Needles will be retained for 30 minutes per session.
干预措施: Acupuncture (Other)
结局指标
主要结局
Change from baseline in Numeric Rating Scale (NRS) scores for average itching severity at week 6.
时间窗: Week 6
This will be assessed using weekly diaries for pruritus evaluation.
次要结局
- Number of episodes of itching per day(Week 2, 4, 6, and week 10, 14, and 18)
- ODS(Week 6, 10, 14, and 18)
- Change from baseline in DLQI(Week 6, 10, 14, and 18)
- PGIC(Week 6, and 18)
- Change from baseline in NRS score for average itching severity(Week 2, 4, 10, 14, and 18)
- Change from baseline in PSQI(Week 6, and 18)
- Change from baseline in HADS(Week 6, and 18)
- Change from baseline in NRS score for maximum itching severity(Week 2, 4, 6, and week 10, 14, and 18)
- Change from baseline in itchy area of the body surface(Week 6, 10, 14, and 18)
研究者
He Chen
Mr.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences