Clinical trial NCT06506240: Effects of Acupuncture for Senile Pruritus
Official title: Effects of Acupuncture for Senile Pruritus: Study Protocol for a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Senile Pruritus
Keywords: Acupuncture
Senile pruritus
Randomized controlled trial
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 108
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Numeric Rating Scale (NRS) scores for average itching severity at week 6.
timeFrame: Week 6
Secondary outcomes:
measure: Change from baseline in NRS score for average itching severity
timeFrame: Week 2, 4, 10, 14, and 18
measure: Change from baseline in NRS score for maximum itching severity
timeFrame: Week 2, 4, 6, and week 10, 14, and 18
measure: Number of episodes of itching per day
timeFrame: Week 2, 4, 6, and week 10, 14, and 18
measure: Change from baseline in itchy area of the body surface
timeFrame: Week 6, 10, 14, and 18
measure: ODS
timeFrame: Week 6, 10, 14, and 18
measure: Change from baseline in DLQI
timeFrame: Week 6, 10, 14, and 18
measure: Change from baseline in PSQI
timeFrame: Week 6, and 18
measure: Change from baseline in HADS
timeFrame: Week 6, and 18
measure: PGIC
timeFrame: Week 6, and 18
Other outcomes:
measure: Adverse events
timeFrame: Week 0 to week 18
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
References: