About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Acupuncture
Other interventionTreatment 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Change from baseline in NRS score for average itching severity
Assessed through weekly diary of pruritus assessment
Change from baseline in NRS score for maximum itching severity
Assessed through weekly diary of pruritus assessment
Number of episodes of itching per day
Assessed through weekly diary of pruritus assessment
Change from baseline in itchy area of the body surface
Measured using the Chinese Rule of Nine
Other outcomes
Adverse events
Adverse events
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