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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
108
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 (Quchi), SP10 (Xuehai), ST36 (Zusanli), SP6 (Sanyinjiao), LR3 (Taichong), LI4 (Hegu), ST25 (Tianshu), CV4 (Guanyuan), GV20 (Baihui), and superior GV29 (superior Yintang). Patients will receive acupuncture or sham acupuncture three times weekly for 6 weeks.
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGChange from baseline in Numeric Rating Scale (NRS) scores for average itching severity at week 6.
This will be assessed using weekly diaries for pruritus evaluation.
Time frame: Week 6
Change from baseline in NRS score for average itching severity
Assessed through weekly diary of pruritus assessment
Time frame: Week 2, 4, 10, 14, and 18
Change from baseline in NRS score for maximum itching severity
Assessed through weekly diary of pruritus assessment
Time frame: Week 2, 4, 6, and week 10, 14, and 18
Number of episodes of itching per day
Assessed through weekly diary of pruritus assessment
Time frame: Week 2, 4, 6, and week 10, 14, and 18
Change from baseline in itchy area of the body surface
Measured using the Chinese Rule of Nine
Time frame: Week 6, 10, 14, and 18
ODS
ODS
Time frame: Week 6, 10, 14, and 18
Change from baseline in DLQI
Change from baseline in DLQI
Time frame: Week 6, 10, 14, and 18
Change from baseline in PSQI
Change from baseline in PSQI
Time frame: Week 6, and 18
Change from baseline in HADS
Change from baseline in HADS
Time frame: Week 6, and 18
PGIC
PGIC
Time frame: Week 6, and 18
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