The Effectiveness of Polydioxanone Thread Embedding Acupuncture Compared to Manual Acupuncture for Nasolabial Fold Reduction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Nasolabial fold length
研究概览
简要总结
This study was aimed to compare the effectiveness of polydioxanone thread embedding acupuncture and manual acupuncture on the reduction of the nasolabial fold. One cycle of therapy in the manual acupuncture group (MA) was carried out with 6 sessions of manual acupuncture therapy while one cycle of therapy in the thread embedding acupuncture group (TEA) received 1 single session of thread embedding acupuncture. The outcome of the study was assessed based on the length of the nasolabial fold as measured by a digital vernier caliper, changes in wrinkle severity rating scale, and patient's subjective opinion of her nasolabial fold using visual analog scale. Outcome measurements were carried out after completing 1 cycle, and follow up at 2 weeks, 1 month, 2 months and 3 months after completing 1 cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 30-50 years old
- •WSRS scale 3 to 4
- •Willing to follow the research to completion
- •Subjects who do not have a history of filler injection and/implants, laser therapy, microdermabrasion, peeling, botulinum toxin therapy, manual acupuncture on the face, thread embedding acupuncture on the face and does not either oral or topically use collagen within 6 months
- •Body mass index of ≥ 18.5
- •Signed the informed consent
排除标准
- •Subjects with facial muscle paralysis disorders
- •Subjects with history of keloids and/or hypertrophic scars, subjects with tumors or infection or inflammation at the treatment area
- •Subjects with allergies to stainless steel, PDO threads, topical anesthetics lidocaine
- •Pregnant and lactating subjects
- •Subjects with cancer
- •Subjects with history of bleeding disorders or are taking anticoagulant or antiplatelet.
- •Subjects suffering from fever (≥ 37.5°C), cough, fatigue
- •Subjects with blood glucose POCT (Point of Care Testing) levels of ≥ 200 mg/dl
研究组 & 干预措施
Manual acupuncture
The subjects/population of this study is woman at age 30-50 who meet the inclusion criteria. Subjects group with manual acupuncture treatment will be treated with 6 session of manual acupuncture at:
From the superior of zygomatic arch through ST 2 to LI 20 bilaterally using a needle size of 0.25 x 60 mm From the inferior of zygomatic arch through SI 18 to ST 4 bilaterally using a needle size of 0.25 x 60 mm From ST 7 to ST 4 bilaterally using a needle size of 0.25 x 60 mm Along the nasolabial crease through ST 4 to the bilateral EXHN-8 using a needle size of 0.25 x 40 mm
干预措施: Manual acupuncture (Other)
Thread embedding acupuncture
The subjects/population of this study is woman at age 30-50 who meet the inclusion criteria. Subjects group with thread embedding acupuncture group treatment will be treated with 1 session of thread embedding acupuncture at:
From the superior of zygomatic arch through ST 2 to LI 20 bilaterally using a gauge and length of the needle of 31G x 50 mm From the inferior of zygomatic arch through SI 18 to ST 4 bilaterally using a gauge and length of the needle of 31G x 50 mm From ST 7 to ST 4 bilaterally using a gauge and length of the needle of 31G x 50 mm Along the nasolabial crease through ST 4 to the bilateral EXHN-8 using a gauge and length of the needle of 31G x 30 mm
干预措施: Thread embedding acupuncture (Other)
结局指标
主要结局
Nasolabial fold length
时间窗: Before intervention (baseline), after completing 1 cycle, at 2 weeks, 1 month, 2 month, and 3 month follow up
Mean difference of nasolabial fold length (measured using digital vernier calipers in millimeters) between two groups
Wrinkle severity rating scale (WSRS)
时间窗: Before intervention (baseline), after completing 1 cycle, at 2 weeks, 1 month, 2 month, and 3 month follow up
Mean difference of WSRS between two groups
次要结局
- Visual analog scale (VAS)(Before intervention (baseline), after completing 1 cycle, at 2 weeks, 1 month, 2 months, and 3 months follow up)
研究者
Yolanda Teja
Resident Doctor of Medical Acupuncture Study Programme University of Indonesia, Indonesia University
Indonesia University