Effects of Acupuncture for Senile Pruritus

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Enrolling

Conditions: Senile Pruritus

Treatments: Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06506240

2024-087-KY

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups

Acupuncture group

Experimental group

Description:

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 , SP10, ST36, SP6, LR3, LI4, ST25, CV4, GV20, and superior GV29. Sterile disposable stainless-steel needles (0.3 mm×40 mm; Hwato brand, Suzhou Medical Appliance Factory, Suzhou, China) will be used. Patients will lie supine, and routine skin sterilization will be performed locally. Needles will be inserted at depths ranging from 10 to 30 mm at the designated acupuncture points. Each needle will be manually manipulated with lifting, thrusting, twirling, and rotating to elicit Deqi sensation (including soreness, numbness, distention, and heaviness). Needles will remain inserted for 30 minutes per session and manipulated three times, every 10 minutes. Acupuncture sessions will be conducted three times weekly over a six-week period.

Treatment:

Other: Acupuncture

Sham acupuncture group

Sham Comparator group

Description:

Patients in the control group will undergo sham acupuncture using sterile disposable stainless-steel needles (0.3 mm×25 mm; Hwato brand, Suzhou Medical Appliance Factory, Suzhou, China). Needles will be inserted to depths of 2 to 3 mm at the same acupuncture points as in the acupuncture group. There will be no needle manipulation or attempt to induce Deqi sensation. Needles will be retained for 30 minutes per session.

Treatment:

Other: Acupuncture