MedPath

Effects of Acupuncture for Senile Pruritus

Not Applicable
Recruiting
Conditions
Senile Pruritus
Registration Number
NCT06506240
Lead Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
108
Inclusion Criteria

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.

Exclusion Criteria

Participants will be excluded if they meet any of the following criteria:

  1. Severe skin damage or infection;
  2. Severe underlying diseases including cardiovascular diseases, hepatobiliary diseases, kidney diseases, hematologic diseases, autoimmune diseases, infectious diseases, severe malnutrition, or malignancies;
  3. Mental illness, cognitive dysfunction, or language disorders;
  4. Received acupuncture therapy for pruritus within the past month;
  5. Have a history of drug abuse.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change from baseline in Numeric Rating Scale (NRS) scores for average itching severity at week 6.Week 6

This will be assessed using weekly diaries for pruritus evaluation.

Secondary Outcome Measures
NameTimeMethod
PGICWeek 6, and 18

PGIC

Number of episodes of itching per dayWeek 2, 4, 6, and week 10, 14, and 18

Assessed through weekly diary of pruritus assessment

ODSWeek 6, 10, 14, and 18

ODS

Change from baseline in DLQIWeek 6, 10, 14, and 18

Change from baseline in DLQI

Change from baseline in NRS score for average itching severityWeek 2, 4, 10, 14, and 18

Assessed through weekly diary of pruritus assessment

Change from baseline in PSQIWeek 6, and 18

Change from baseline in PSQI

Change from baseline in HADSWeek 6, and 18

Change from baseline in HADS

Change from baseline in NRS score for maximum itching severityWeek 2, 4, 6, and week 10, 14, and 18

Assessed through weekly diary of pruritus assessment

Change from baseline in itchy area of the body surfaceWeek 6, 10, 14, and 18

Measured using the Chinese Rule of Nine

Trial Locations

Locations (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

🇨🇳

Beijing, Beijing, China

Guang'anmen Hospital, China Academy of Chinese Medical Sciences
🇨🇳Beijing, Beijing, China
He Chen
Contact
+86 19927523321
chenhenick@gmail.com
© Copyright 2025. All Rights Reserved by MedPath