Investigation of the Efficacy of Therapeutic Ultrasound in the Treatment of Migraine; Prospective, Randomized, Placebo Controlled, Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Numeric rating scale (NRS)
研究概览
简要总结
Headache affects the daily quality of life of patients. It has been reported that headaches may be associated with neck muscles, neck movements and trigger points in the neck Drug and non-drug treatments can be used today in the treatment of headaches. Various physical therapies are applied to cranial and cervical regions in non-drug therapies. Therapeutic ultrasound, Transcutaneous Electrical Nerve Stimulation (TENS), Hotpack and manipulation are some of them.This is a randomised placebo- controlled trial to determine the efficacy of the therapeutic ultrasound in the treatment of migraine.
详细描述
Evidence from controlled studies suggests that non-invasive physical therapies may help prevent headaches. Therapeutic ultrasound studies have generally been used in combination with other physical therapies.
Therapeutic ultrasound is known to act in two different ways, thermal and non-thermal. With thermal effect, it is possible to reduce pain and joint joints and increase local blood flow, while stimulating tissue regeneration, soft tissue repair, blood flow regulation in chronic ischemic tissues and protein synthesis with nonthermal effect. In addition, its effect on inflammation accelerated repair by affecting cell activities, altering platelet membrane permeability, leading to the release of serotonin and accelerating wound healing.
The aim of this study is to determine whether therapeutic ultrasound is superior to placebo ultrasound in the treatment of migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 20-65 years
- •Patients diagnosed with migraine according to the International Headache Society (IHS) criteria
排除标准
- •Patients with bleeding disorders,
- •Patients with mental disorders,
- •Patients with malignancy,
- •Patients with uncontrolled hypertension,
- •Patients with uncontrolled diabetes mellitus,
- •Patients with infection,
- •Patients who underwent surgery in the posterior cranial region and cervical vertebra.
研究组 & 干预措施
Group A
Group A: ultrasound group
干预措施: therapeutic ultrasound (Device)
Group P
Group P: placebo ultrasound group
干预措施: placebo ultrasound (Device)
结局指标
主要结局
Numeric rating scale (NRS)
时间窗: 4 months
It is commonly used to measure the severity of the patients' pain. It consists of a line 10 cm. long and marked with numbers from 0 to 10. The patient is asked to mark the point corresponding to the severity of the pain on this line in the range from 0 (no pain) to 10 (most severe pain).
Migraine Disability Assessment Questionnaire Score (MIDAS)
时间窗: 4 months
The Migraine Disability Assessment (MIDAS) questionnaire is a brief, self-administered questionnaire designed to quantify headache-related disability over a 3 month period. The MIDAS score is based on five disability questions in three dimensions: questions one and two assess the number of missed or significant limitations to activity (defined as at least 50% reduced productivity) days due to headache in school or paid work activities (school/job dimension); questions three and four assess the number of missed or significant limitations to activity (defined as at least 50% reduced productivity) days due to headache in housework activities (housework dimension); question five assesses missed days due to headache in family, social, or leisure activities (social dimension). 0 to 5 - MIDAS Grade I, Little or no disability 6 to 10 - MIDAS Grade II, Mild disability 11 to 20 - MIDAS Grade III, Moderate disability 21+ - MIDAS Grade IV, Severe disability
次要结局
- paracetamol consumption(4 months)
- the number of migraine attacks per month.(4 months)
研究者
Dr. Burcu Metin Ökmen
Principal Investigator
Bursa Yüksek İhtisas Education and Research Hospital