Transcutaneous Vagus Nerve Stimulation As a Pain Modulator in Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- visual analogue scale
研究概览
简要总结
a single-blinded, randomized clinical trial, 68 patients divided into 2 groups: active and sham treatment. Afferents of the Auricular branch of vagus nerve are stimulated using a transcutaneous Vagus Nerve Stimulation device (TENS 7000TM). The electrode was placed in the left cymba concha with direct contact on the skin. The stimulation for both groups will last for 30 minutes once a day for 3 days per week for 12 weeks. The amplitude of the output current was between 0.25-2.0 mA as tolerated and 250 µs width at 25 Hz. All participants initially will be evaluated before and after intervention and 3 months after the end of the sessions.
详细描述
The included study population is 68.
- Group (1): (tVNS group): This group of study subjects will include 34 patients of knee osteoarthritis and will be subjected to tVNS.
- Group (2): (sham group): This group of study subjects will include 34 patients of knee osteoarthritis and will be subjected to sham treatment.
DESCRIPTION OF THE TECHNIQUE
Active treatment:
Afferents of the Auricular branch of vagus nerve were stimulated using a t-VNS device (TENS 7000TM made by Roscoe Medical Inc., will be used. TENS 7000TM device was labeled as nerve stimulator and low-risk medical device (Instruction manual for TENS 7000). The electrode was placed in the left cymba concha with direct contact on the skin after cleaning with an alcohol swab. The stimulation for both groups will last for 30 minutes once a day for 3 days per week for 12 weeks. The amplitude of the output current was between 0.25-2.0 mA as tolerated and 250 µs width at 10 Hz.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders.
- •Adult over 18 years.
- •People who were diagnosed.
- •Reported pain on visual analogue scale (VAS)>4/
- •Able to understand the informed consent.
排除标准
- •Peptic ulcer
- •Pace maker
- •Asthma or severe chronic obstructive pulmonary disease
- •Pregnancy.
- •Cellulites, skin ulceration at area of therapy application.
- •Inability to fulfill follow-up criteria.
结局指标
主要结局
visual analogue scale
时间窗: 3 months
to describe pain on 0 to 10 scale
次要结局
- Knee injury and Osteoarthritis Outcome Score (KOOS)(3 months)
研究者
Gehad Gamal Elsehrawy
Assistant Lecturer
Suez Canal University