Comparative effectiveness of Deep, Superficial and Sham Dry Needling on Migraine headache - A randomized clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- 1. Headache frequency will be recorded as the number of headache days in the past week.
研究概览
简要总结
Migraine is associated with a wide range of comorbidities, which range from stress and sleep disturbances to suicide. Migraine Headache prevalence is found to be on the rise due increase in screen time, stress and busy lifestyle.
Aim of this study is to assess the short-term and long-term effectiveness of Deep, Superficial and Sham Dry Needling on headache frequency, intensity, health-related quality of life and pressure-pain threshold in migraine patients.
Objective is to assess the short-term and long-term effectiveness of Deep Dry Needling on headache frequency, intensity, health-related quality of life and pressure-pain threshold in migraine patients.
Procedure: Baseline assessment will be done. Subjects will be divided into 3 groups:
- Deep Dry Needling + Standard Treatment
- Superficial Dry Needling + Standard Treatment
- Sham Dry Needling+ Standard Treatment
All types of Dry needling techniques will be performed twice a week (approximately 10 min per session) for 4 weeks with minimum 24 hours of gap in between.
A follow up assessment will be after 4 weeks, and 3 months and 6 months from the start of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects diagnosed with Episodic Migraine without aura by a Medical Practitioner 2)Subjects of all genders 3)Age between 25-40 years 4)Migraine headache more than 6 months 5)Headache Pain intensity minimum 6 on the Numeric Pain rating Scale (NRS) on average.
- •Minimum 1 episode of migraine headache in previous week.
- •At least one active TrP in minimum 2 of the following muscle – Suboccipetal, Upper Trapezius, Sternocleidomastoid ipsi-laterally over the symptomatic side reproducing their headache symptoms.
排除标准
- •History of head or neck trauma or surgery 2) Cervical radiculopathy 3) Physiotherapy in the cervical area during the previous 3 months 4) Pregnancy 5) Contraindication to DN 6) Any local or systemic infections.
结局指标
主要结局
1. Headache frequency will be recorded as the number of headache days in the past week.
时间窗: 1. Baseline | 2. Post Intervention (4 weeks) | 3. After 3 months | 4. After 6 months
2. A Numerical pain rating scale will be used to assess average headache intensity in past week.
时间窗: 1. Baseline | 2. Post Intervention (4 weeks) | 3. After 3 months | 4. After 6 months
3. Health-related quality of life will be measured using Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ)
时间窗: 1. Baseline | 2. Post Intervention (4 weeks) | 3. After 3 months | 4. After 6 months
4. Pressure-pain threshold will be measured using a manual Mechanical Algometer over Upper Trapezius and Suboccipital muscle.
时间窗: 1. Baseline | 2. Post Intervention (4 weeks) | 3. After 3 months | 4. After 6 months
次要结局
- • A Numerical pain rating scale will be used to assess average headache intensity in past week.(• Health-related quality of life will be measured using Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ))
研究者
Dr Priya Sahasrabuddhe PT
Smt Kashibai Navale College of Physiotherapy