NCT06506240

Effects of Acupuncture for Senile Pruritus

Effects of Acupuncture for Senile Pruritus: Study Protocol for a Randomised Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Senile Pruritus

Interventions

Type	Name	Description
OTHER	Acupuncture	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.

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2024-07-17
• Last updated: 2024-11-20

Locations

1 site across 1 country: China