Effect of neural mobilization technique on pain and headache related disability among young adults with tension-type headache: A randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Two tools (a scale and a questionnaire/inventory) will be used to assess the outcome in this study.
研究概览
简要总结
This randomized controlled trial investigates the effect of the Neural Mobilization Technique (NMT) on pain and disability in young adults with Tension-Type Headache (TTH). Forty participants, aged 18-25, will be randomly assigned to either an NMT group, a self-relaxation massage (SRM) group, or a control group. The NMT group will receive specific cranio-cervical and mandibular mobilizations combined with self-relaxation techniques. The control group will be taught to perform SRM after initial application. Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS) and disability through the Headache Disability Index (HDI). Assessments will occur at baseline, 2nd week (interim), 4 weeks post-intervention, and 6 weeks after. Data analysis will involve both categorical and continuous variables, with the results analyzed using appropriate statistical tests such as ANOVA for repeated measures or the Friedman test for non-parametric data, and independent t-tests or Mann-Whitney U tests where necessary as per the normality. Interim Analysis performed. (Intension to treat analysis specified). The study aims to determine whether NMT can significantly reduce pain and improve headache-related disability, offering a non-pharmacological treatment option for TTH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •Young adults between 18-25 years of age.
- •Patients with any of the two following symptoms of TTH mentioned in the international classification of headache disorders (ICHD-3).
- •Pain in bilateral location.
- •Pressing or tightening (non-pulsating) quality.
- •Mild or moderate intensity.
- •Not aggravated by daily activities like climbing stairs or walking.
- •Presence of tender points and trigger points in the peri-cranial, neck and upper back region.
排除标准
- •Participants with neurological disorders, fibromyalgia, or systemic conditions that could affect headache or musculoskeletal symptoms.
- •Patients already undergoing TCA medication or any other physiotherapy for Tension type headache.
- •Individuals with significant psychiatric conditions (e.g., severe anxiety or depression) that might interfere with study outcome.
结局指标
主要结局
Two tools (a scale and a questionnaire/inventory) will be used to assess the outcome in this study.
时间窗: Both NPRS and HDI: | Baseline (0 week) | Post treatment (4 Weeks) | and Follow up (6 weeks)
1. Numeric Pain Rating Scale (NPRS)
时间窗: Both NPRS and HDI: | Baseline (0 week) | Post treatment (4 Weeks) | and Follow up (6 weeks)
2. Headache Disability Index (HDI)
时间窗: Both NPRS and HDI: | Baseline (0 week) | Post treatment (4 Weeks) | and Follow up (6 weeks)
次要结局
- 1. Numeric Pain Rating Scale (NPRS)(2. Headache Disability Index (HDI))
研究者
Huzaifa Yaman Arihole
Yenepoya Physiotherapy College Mangalore