Efficacy of Integrative Therapy Combining Vestibular Rehabilitation, Vagus Nerve Stimulation, and Craniofacial Release for Tension-Type Headache with Coexisting Vestibular Dysfunction: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Change in number of headache days per month from baseline to 12 weeks
研究概览
简要总结
This randomized controlled trial aims to evaluate the clinical efficacy and safety of an integrative non-pharmacological intervention combining Vestibular Rehabilitation (VT), Transcutaneous Vagus Nerve Stimulation (tcVNS), and Craniofacial Release (CFR) in patients with chronic tension-type headache and coexisting vestibular dysfunction. A total of 135 participants aged 18–65 years will be randomly allocated into three groups: (1) VT alone (control), (2) VT + tcVNS, and (3) VT + tcVNS + CFR (experimental group). The primary outcome is the reduction in headache frequency after 12 weeks of intervention. Secondary outcomes include headache intensity, dizziness handicap, quality of life, pericranial muscle tenderness, autonomic balance (measured by HRV), and safety assessment. The study will follow a single-blinded, parallel-arm design, with all interventions delivered twice weekly for 12 weeks. This trial seeks to establish the added benefit of integrative therapy over standard vestibular rehabilitation in managing tension-type headache with vestibular dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants eligible for inclusion in the study were adults aged between 18 and 65 years with a clinical diagnosis of chronic tension-type headache according to the International Classification of Headache Disorders, third edition (ICHD-3) criteria.
- •In addition, participants were required to have coexisting vestibular dysfunction, confirmed by clinical assessment and a Dizziness Handicap Inventory (DHI) score greater than
- •All participants were required to provide written informed consent and express willingness to comply with the study protocol.
排除标准
- •Participants were excluded if they had secondary headache disorders, a history of epilepsy, severe psychiatric illness, or the presence of a cardiac pacemaker.
- •Pregnant or lactating women were also excluded due to unknown effects of the interventions on fetal and neonatal health.
- •Individuals with recent head trauma within the past six months or those currently enrolled in other clinical trials were not eligible to participate, to avoid confounding factors and ensure the safety and scientific validity of the study results.
结局指标
主要结局
Change in number of headache days per month from baseline to 12 weeks
时间窗: Change in number of headache days per month from baseline to 12 weeks
次要结局
- Change in headache intensity (VAS scale, 0–10)
研究者
Dr Ramesh Chandra Patra
Lovely Professional University Faculty of Applied Medical Sciences