Effectiveness of Electro-Acupuncture as an Alternative Therapy among Oral Sub-Mucous Fibrosis patients- A Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1) To evaluate pain score 0-10, mouth opening and burning sensation of mouth score 0-10
研究概览
简要总结
This study is a randomised controlled trial comparing the effectiveness of electro-acupuncture therapy in reducing pain, improving mouth opening and reducing burning sensation among 50 oral sub-mucous fibrosis patients along with conventional treatment in India.
The primary outcome measures will be:
- To evaluate the effectiveness of electro-acupuncture therapy in reducing pain, improving mouth opening and reducing burning sensation of mouth in patients with grade I to grade III oral sub-mucous fibrosis along with conventional treatment.
2. To compare the effect of electro-acupuncture intervention along with conventional treatment and only conventional treatment.
The secondary outcomes will be:
1. To compare the effectiveness of pain and mouth opening between Grade I, Grade II and Grade III oral sub-mucous fibrosis patients in experimental and control group.
- To assess the patient acceptance and satisfaction of electro-acupuncture as an alternate therapy.
NULL HYPOTHESIS:
1. There is NO difference in pain, mouth opening and burning sensation amongst patients who receive electro-acupuncture therapy along with conventional treatment for Grade I to Grade III Oral Sub-Mucous Fibrosis.
-
Electro-acupuncture therapy along with conventional treatment is NOT effective in comparison with conventional treatment in patients with Grade I to Grade III Oral Sub-Mucous Fibrosis.
-
There is NO significant difference in pain and mouth opening among Grade I, Grade II, and Grade III Oral Sub-Mucous Fibrosis patients between the experimental and control groups.
-
Electro-acupuncture does NOT lead to significant levels of patient acceptance and satisfaction in the treatment of Grade I to Grade III oral sub-mucous fibrosis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Oral sub-mucous fibrosis patients suffer from severe burning sensations, dry mouth, pain, taste disorders, tongue mobility limitations less than 35mm, trismus, dysphagia, and altered tone.
排除标准
- •A history of bleeding disorder, acupuncture treatment, pregnant or lactating women and subjects with wounds/ tumour in the area of needling.
结局指标
主要结局
1) To evaluate pain score 0-10, mouth opening and burning sensation of mouth score 0-10
时间窗: Every week for 1month and at the end of 2nd month
2) To compare the effect of electro-acupuncture intervention along with conventional treatment and only conventional treatment.
时间窗: Every week for 1month and at the end of 2nd month
次要结局
- To compare the effectiveness of pain and mouth opening between Grade I, Grade II and Grade III oral sub-mucous fibrosis patients in experimental and control group.(2months)
- To assess the patient acceptance score 0-10 and satisfaction score 0-10 of electro-acupuncture as an alternate therapy.(At the end of 1st month)
研究者
Dr S Priyanka
Shri Dharmasthala Manjunatheshwara College Of Dental Sciences And Hospital