Senile Pruritus
Conditions
Keywords
Acupuncture, Senile pruritus, Randomized controlled trial
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.
Interventions
OTHERAcupuncture
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.
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in NRS score for average itching severity | Week 2, 4, 10, 14, and 18 | Assessed through weekly diary of pruritus assessment |
| Change from baseline in NRS score for maximum itching severity | Week 2, 4, 6, and week 10, 14, and 18 | Assessed through weekly diary of pruritus assessment |
| Number of episodes of itching per day | Week 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 surface | Week 6, 10, 14, and 18 | Measured using the Chinese Rule of Nine |
| Change from baseline in DLQI | Week 6, 10, 14, and 18 | Change from baseline in DLQI |
| Change from baseline in PSQI | Week 6, and 18 | Change from baseline in PSQI |
| Change from baseline in HADS | Week 6, and 18 | Change from baseline in HADS |
| PGIC | Week 6, and 18 | PGIC |
| ODS | Week 6, 10, 14, and 18 | ODS |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Week 0 to week 18 | Adverse events |
Countries
China
Contacts
Primary ContactHe Chen
Outcome results
None listed