Effectiveness of a Cognitive and Physical Program in Reducing Headache, Neck and Shoulder Pain: a Workplace Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 主要终点
- Frequency of headache and neck and shoulder pain after 6 months (monthly frequency, responder rate)
研究概览
简要总结
The primary purpose of this study is to evaluate the effectiveness of a workplace cognitive and physical program (Intervention), in reducing the frequency of head and neck pain
详细描述
Many studies have been performed to assess the efficacy of non invasive physical interventions in the treatment of different types of headache and cervical pain. However the evidence on their effectiveness is still limited and the results of recent studies are conflicting.
The primary objective of this study is to evaluate the effectiveness of a workplace cognitive and physical programme (Intervention) in reducing the frequency of pain involving the head and neck area. The Intervention consists of brief shoulder and neck exercises to be performed several times a day, a relaxation exercise and instructions of how to reduce parafunction and hyperfunction of the craniofacial and cervical muscles during the day.
Comparison(s): Group of employees that will receive a cognitive/physical programme (Intervention), compared to a similar group of employees that will not receive the Intervention (Controls); (frequency of headache and neck and shoulder pain).
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects employed at the Municipality of Turin ( Registry-Tax office) from the 1th January 2005 that will give informed consent before starting the study.
排除标准
- •Because of the pragmatic design, no exclusion criteria are required for this study
结局指标
主要结局
Frequency of headache and neck and shoulder pain after 6 months (monthly frequency, responder rate)
时间窗: 6 months
次要结局
- Analgesic drug consumption after 6 and 12 months(12 months)
- Headache index after 6 and 12 months(12 months)
- Neck and shoulder pain index after 6 and 12 months(12 months)
- Muscle tenderness at palpation after 6 and 12 months(12 months)
- Psychiatric comorbidity and psychosomatic symptoms prevalence(12 months)
- Frequency of pain in head/neck area after 12 months in both groups(12 months)