Comparison of the Effect of Manuel Therapy on Tension Type Headache in Menopausal and Premenopasual Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain İntensity (Visual Analog Scale - VAS)
研究概览
简要总结
This study aims to investigate the effectiveness of manual therapy in women with tension-type headache and to compare treatment outcomes between menopausal and premenopausal women. Hormonal changes occurring during menopause may influence pain perception and headache characteristics.
Participants diagnosed with tension-type headache will receive manual therapy interventions. Headache intensity, headache-related disability, pressure pain threshold, cervical range of motion, sleep quality, and quality of life will be evaluated before and after treatment using validated assessment tools. The results are expected to contribute to physiotherapy approaches in women experiencing tension-type headache during different hormonal periods.
详细描述
Tension-type headache (TTH) is the most prevalent type of primary headache and is characterized by bilateral, pressing, or tightening pain of mild to moderate intensity. It has a considerable impact on daily activities, psychological status, sleep quality, and overall quality of life. Hormonal changes occurring during the menopausal transition may influence pain perception, musculoskeletal sensitivity, and headache characteristics. Therefore, investigating treatment responses in different hormonal periods may provide valuable clinical insights.
The aim of this study is to investigate and compare the effectiveness of manual therapy applications in menopausal and premenopausal women with tension-type headache. The study will include women diagnosed with tension-type headache who meet the inclusion criteria. Participants will be evaluated before and after the intervention period.
Manual therapy interventions including soft tissue techniques, cervical mobilization, and therapeutic exercises will be applied. Outcome measures will include headache intensity assessed with the Visual Analog Scale (VAS), headache-related disability evaluated using the Headache Impact Test (HIT-6), pressure pain threshold measured by algometer, cervical range of motion assessed using a goniometer, sleep quality evaluated with the Pittsburgh Sleep Quality Index (PSQI), and health-related quality of life measured with the Short Form-36 (SF-36).
The results of this study are expected to provide evidence regarding the role of manual therapy in the management of tension-type headache and contribute to physiotherapy practices targeting women in different hormonal stages.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This study is an open-label study. No masking will be applied to participants, care providers or investigators
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged between 45 and 65 years.
- •Diagnosis of tension-type headache.
- •Premenopausal or menopausal status.
- •HIT-6 score of 49 or higher.
- •Willingness to participate in the study.
排除标准
- •Use of hormone therapy.
- •History of cervical surgery.
- •History of neurological disease.
- •Pregnancy.
- •Inability to understand questionnaire forms.
- •Failure to attend treatment sessions.
研究组 & 干预措施
Premenopausal Women With Tension-Type Headache
Premenopausal women diagnosed with tension-type headache who will receive manual therapy interventions during the study.
干预措施: Manuel Therapy (Procedure)
Menopausal Women With Tension-Type Headache
Menopausal women diagnosed with tension-type headache who will receive manual therapy interventions during the study.
干预措施: Manuel Therapy (Procedure)
结局指标
主要结局
Pain İntensity (Visual Analog Scale - VAS)
时间窗: Baseline and after 2 weeks of treatment
Pain intensity will be assesed using the Visual Analog Scale (VAS). Participants will rate their pain on a 10 cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain)
Headache İmpact (Headache İmpact Test - HİT-6)
时间窗: Baseline and after 2 weeks of treatment
Headache-related disability will be evaluted using the Headache İmpact Test (HİT-6). This questionnaire assesses the impact of headaches on daily functioning, social activities and overall quality of life.
次要结局
- Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)(Baseline and after 2 weeks of treatment)
- Quality of Life (SF-36)(Baseline and after 2 weeks of treatment)
- Pressure Pain Threshold(Baseline and after 2 weeks of treatment)
- Cervical Range of Motion(Baseline and after 2 weeks of treatment)
- Executive Function (Trail Making Test Part B)(Baseline and after 2 weeks of treatment)
- Depression Severity (Beck Depression Inventory)(Baseline and after 2 weeks of treatment)
研究者
Ayça Seda
Principal Investigator
Necmettin Erbakan University