Effects of Acupuncture for Senile Pruritus

NCT06506240 | Recruiting

• 1 other identifier: 2024-087-KY
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Senile Pruritus

Keywords

Acupuncture; Senile pruritus; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change from baseline in NRS score for average itching severity

  Week 2, 4, 10, 14, and 18

• Change from baseline in NRS score for maximum itching severity

  Week 2, 4, 6, and week 10, 14, and 18

• Number of episodes of itching per day

  Week 2, 4, 6, and week 10, 14, and 18

• Change from baseline in itchy area of the body surface

  Week 6, 10, 14, and 18

• ODS

  Week 6, 10, 14, and 18

Other Outcomes (1)

• Adverse events

  Week 0 to week 18

Study Arms (2)

Acupuncture group

EXPERIMENTAL

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

Sham acupuncture group

SHAM COMPARATOR

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

Interventions

Acupuncture OTHER

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.

Acupuncture group; Sham acupuncture group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Participants will be excluded if they meet any of the following criteria:
• 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;
• Have a history of drug abuse.

Sponsors & Collaborators

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

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (1)

• Chen H, Liu S, Gao S, Yi J, Shi H, Fang J, Wang W, Chen H, Liu Z. Effects and safety of acupuncture versus non-penetrating sham acupuncture for senile pruritus: Rationale and design for a randomized controlled trial. Contemp Clin Trials Commun. 2025 Feb 12;44:101454. doi: 10.1016/j.conctc.2025.101454. eCollection 2025 Apr.

  PMID: 40027278 DERIVED

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

He Chen

CONTACT

+86 19927523321; chenhenick@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients meeting the eligibility criteria for SP will be randomly assigned to either the acupuncture or sham acupuncture groups in a 1:1 ratio. The randomization sequence was generated using the blockrand package in R software (version 4.1.1) and is detailed in the supplementary materials. The sequence will be enclosed in sealed, opaque, sequentially numbered envelopes, which will be opened after participants complete all baseline assessments. Allocation to the assigned group will be conducted by a research assistant who is not involved in treatment or outcome assessments. Participants, outcome assessors, and the statistician will be blinded to group assignments, ensuring unbiased evaluation. However, the practitioner administering the intervention will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr.

Model Details: This trial is a single-center, parallel-arm, randomized, sham-controlled clinical trial. Eligible participants are randomized and allocated to either the acupuncture or sham acupuncture groups at a 1:1 ratio.

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: March 1, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (1)