Evaluating the Efficacy of Transcutaneous Electrical Nerve Stimulation and Myofascial Release among Young Females with Cervicogenic Headache- A pilot feasibility trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain Intensity (VAS): Measure reduction in pain severity using the Visual Analog Scale (VAS).
研究概览
简要总结
This pilot feasibility trial investigates the effectiveness of a combination therapy using Transcutaneous Electrical Nerve Stimulation (TENS) and Myofascial Release (MFR) in young females with cervicogenic headache (CGH). CGH, a secondary headache originating from the cervical spine, can result in chronic discomfort, limited neck mobility, and reduced quality of life. While TENS is commonly used for pain relief by delivering low-voltage electrical currents to stimulate nerves, MFR is a manual technique aimed at releasing muscle tightness and improving tissue flexibility. Both therapies are non-invasive and are widely used for pain management, but limited research has examined the synergistic effects of using them together.
The primary objective of this study is to assess the feasibility, safety, and initial therapeutic outcomes of combining TENS and MFR in managing CGH. Outcome measures include the frequency, intensity, and duration of headaches, as well as functional capacity and overall quality of life. By evaluating participant adherence, tolerance, and any adverse effects, this study will determine the practicality of conducting a larger randomized controlled trial on this combination therapy.
Preliminary findings could reveal whether TENS and MFR offer complementary effects that enhance pain management, allowing young females with CGH to experience improved physical function and daily comfort. This research contributes to expanding non-pharmacological treatment options for CGH, emphasizing personalized and accessible interventions. If successful, the study could pave the way for more comprehensive approaches in treating CGH, providing an evidence base for integrating TENS and MFR into clinical practice for this demographic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
入选标准
- •1.Gender: Only females will be included in the study.
- •Age Range: Participants aged between 20-40 years.
- •Diagnosis: Clinically diagnosed with cervicogenic headaches as per standardized diagnostic criteria.
- •Duration of Symptoms: Suffering from cervicogenic headaches for a minimum of 3 months.
- •Pain Intensity: Baseline headache intensity of moderate to severe on the visual analog scale (VAS).
- •Willingness to Participate: Participants must provide written informed consent and agree to adhere to the treatment protocol and follow-up schedule.
- •No Recent Treatment: Participants must not have received any physiotherapy, TENS, or manual therapy interventions in the last 3 months.
排除标准
- •Other Headache Types: Exclude participants diagnosed with migraines, tension-type headaches, or any other primary headache disorders.
- •Neck or Spine Surgery: Exclusion of individuals with a history of cervical spine surgery or other surgical interventions.
- •Neurological Disorders: Those with neurological conditions like multiple sclerosis or epilepsy that could influence treatment outcomes.
- •Chronic Pain Syndromes: Exclude individuals diagnosed with fibromyalgia, rheumatoid arthritis, or other systemic musculoskeletal or autoimmune disorders.
- •Pregnancy: Pregnant women or those planning to become pregnant during the study period.
- •Pacemaker or Electrical Implants: Exclude participants with pacemakers or other implanted electrical devices that could interfere with TENS therapy.
- •Psychiatric Conditions: Severe psychiatric disorders (e.g., major depressive disorder, schizophrenia) that might impact the perception of pain or adherence to treatment protocols.
结局指标
主要结局
Pain Intensity (VAS): Measure reduction in pain severity using the Visual Analog Scale (VAS).
时间窗: at baseline
Headache Frequency: Track the number of headache episodes per week.
时间窗: at baseline
Cervical Range of Motion (ROM): Assess improvements in neck mobility.
时间窗: at baseline
Patient Global Impression of Change (PGIC): Evaluate overall patient-reported improvement after treatment.
时间窗: at baseline
次要结局
- Neck Disability Index (NDI): Measure disability caused by neck pain and its impact on daily activities.(Quality of Life (SF-36 or EQ-5D): Assess changes in overall physical, emotional, and social well-being.)
研究者
Dr Sumera Khan
galgotias university