Investigating the Efficacy of Electrical Dry Needling for Auricular Vagus Nerve Stimulation Combined with Craniofacial Manual Therapy in the Management of Cervicogenic Headache and Temporomandibular Disorders: A Randomized Controlled Trial
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Headache Intensity
研究概览
简要总结
This study is a randomized controlled trial to evaluate the efficacy of combining electrical dry needling targeting the auricular branch of the vagus nerve with craniofacial manual therapy for the management of cervicogenic headache and temporomandibular disorders. Sixty adults aged 18 to 65 years diagnosed with both conditions will be randomly assigned to either an experimental group receiving combined therapy or a control group receiving craniofacial manual therapy alone. The intervention will be administered twice weekly for six weeks. Primary outcomes include headache intensity measured by visual analog scale, headache frequency, temporomandibular joint dysfunction assessed by the Helkimo index, jaw pain intensity, and mouth function assessed by the mandibular functional impairment questionnaire. Secondary outcomes include pressure pain threshold, autonomic nervous system balance assessed by heart rate variability parameters, and quality of life measured by SF36 questionnaire. Assessments will be conducted at baseline, after six weeks of intervention, and at twelve weeks follow-up to evaluate both immediate and long term effects. The study aims to determine whether the combined intervention provides superior outcomes compared to manual therapy alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants eligible for the study must have a confirmed diagnosis of cervicogenic headache according to the International Classification of Headache Disorders criteria, as well as a diagnosis of temporomandibular disorders based on the DC/TMD criteria.
- •They must have experienced chronic symptoms for at least three months and provided written informed consent to participate.
排除标准
- •Individuals will be excluded if they have known contraindications to dry needling or manual therapy, suffer from severe systemic illness, are pregnant or lactating, have psychiatric disorders that may interfere with participation, or have experienced recent trauma or surgery in the craniofacial region within the last six months.
结局指标
主要结局
Headache Intensity
时间窗: Baseline, 6 weeks and 12 weeks
Measured using the Visual Analog Scale (VAS), assessed before and after the intervention to quantify the subjective intensity of cervicogenic headache.
时间窗: Baseline, 6 weeks and 12 weeks
Headache Frequency
时间窗: Baseline, 6 weeks and 12 weeks
Number of headache days per month, recorded using a headache diary, compared pre- and post-intervention.
时间窗: Baseline, 6 weeks and 12 weeks
Temporomandibular Joint Dysfunction
时间窗: Baseline, 6 weeks and 12 weeks
Assessed using the Helkimo Clinical Dysfunction Index, which evaluates TMJ function, joint sounds, range of motion, and pain.
时间窗: Baseline, 6 weeks and 12 weeks
Jaw Pain Intensity
时间窗: Baseline, 6 weeks and 12 weeks
Measured using a Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst pain possible), recorded pre- and post-intervention to assess changes in TMD-related pain.
时间窗: Baseline, 6 weeks and 12 weeks
Mouth Function
时间窗: Baseline, 6 weeks and 12 weeks
Assessed by the Mandibular Functional Impairment Questionnaire (MFIQ), which evaluates difficulty in performing functional activities such as chewing, speaking, yawning, and mouth opening.
时间窗: Baseline, 6 weeks and 12 weeks
次要结局
- Pressure Pain Threshold (PPT)(Measured using an algometer at standardized points in the craniofacial and cervical regions to objectively quantify sensitivity and mechanical pain thresholds.)
研究者
Dr Ramesh Chandra Patra
Lovely Professional University Faculty of Applied Medical Sciences