Effects of Acupuncture for Senile Pruritus
NCT Number: NCT06506240
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Senile Pruritus
Interventions: OTHER: Acupuncture
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2026-02-28
Locations: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, Beijing, 100053, China

Summary:
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 64 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.

Primary Outcome Measures: Change 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., Week 6
Secondary Outcome Measures: Change from baseline in NRS score for average itching severity, Assessed through weekly diary of pruritus assessment, Week 2, 4, 10, 14, and 18|Change from baseline in NRS score for maximum itching severity, Assessed through weekly diary of pruritus assessment, Week 2, 4, 6, and week 10, 14, and 18|Number of episodes of itching per day, Assessed through weekly diary of pruritus assessment, 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, Week 6, 10, 14, and 18|ODS, ODS, Week 6, 10, 14, and 18|Change from baseline in DLQI, Change from baseline in DLQI, Week 6, 10, 14, and 18|Change from baseline in PSQI, Change from baseline in PSQI, Week 6, and 18|Change from baseline in HADS, Change from baseline in HADS, Week 6, and 18|PGIC, PGIC, Week 6, and 18
Other Outcome Measures: Adverse events, Adverse events, Week 0 to week 18