Effects of Acupuncture for Senile Pruritus

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

Study Overview

• Status: Recruiting
• Conditions: Senile Pruritus
• Intervention / Treatment: Other: Acupuncture

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: He Chen; Phone Number: +86 19927523321; Email: chenhenick@gmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
      • Contact: He Chen; Phone Number: +86 19927523321; Email: chenhenick@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture group; 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.	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.
Sham Comparator: Sham acupuncture group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Adverse events	Adverse events	Week 0 to week 18

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Acupuncture; Randomized controlled trial; Senile pruritus
• Additional Relevant MeSH Terms: Skin Manifestations; Skin Diseases; Pruritus
• Other Study ID Numbers: 2024-087-KY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol, statistical analysis plan, informed consent form (ICF) will be shared.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No