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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events | Week 0 to week 18 |
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| He Chen | Contact | +86 19927523321 | chenhenick@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital, China Academy of Chinese Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40027278 | Derived | 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. |
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The study protocol, statistical analysis plan, informed consent form (ICF) will be shared.
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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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.
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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.
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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 |