A Comparative Study of Postural Garment Versus Exercises for Women With Non-specific Cervical Pain: a Randomised Crossover Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change from baseline cervical Pain measured with a visual analog scale at 3 months
研究概览
简要总结
This study aim to compare a new postural garment (Posture Plus Force ®) versus exercises in women with non specific cervical pain. The investigators focus on nurses and allied health professionals due to the importance of posture in work related musculoskeletal disorders.
详细描述
OBJECTIVE: To investigate the effects of a postural garment versus exercises in nurses with non-specific cervical pain.
DESIGN: Randomized cross over clinical trial with a 3 months sequence treatment and a 3 months washout period..
PARTICIPANTS: Nurses and allied health professionals with cervical pain aged 21 to 55 years.
INTERVENTIONS:
Participants are allocated at random to receive interventions in two groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Postural assessment is performed by a blinded investigator with a device for computerized measurement of surface curvature in the upright position (SpinalMouse®).
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nurses and health allied professionals females with cervical pain
- •Voluntarily signed informed consent
- •Able to wear the garment and to do exercises and follow up assessments
排除标准
- •Pregnancy
- •Malignancy or other severe disease
- •Cervical pain with significant extremity symptoms and/or neurological dysfunction (cervical radiculopathy and cervical spondylotic myelopathy)
- •Unable to perform exercises
- •Unwilling to do follow up assessments
- •Psychiatric disorders
结局指标
主要结局
Change from baseline cervical Pain measured with a visual analog scale at 3 months
时间窗: Pain is assessed pre-intervention (Day 0) and at Month 3 of follow-up.
Visual analogue scale is a psychometric measuring instrument designed to document cervical pain severity in individual subjects. It achieves a rapid (statistically measurable and reproducible) classification of symptom severity. A 100-mm long horizontal line with verbal descriptors is used to grade the amount of pain that a patient feels from no pain (left 0 mm) to an extreme amount of pain (right 100 mm).
Change from baseline cervical Pain at 3 months (after the wash out period)
时间窗: After the washout period, pain is assessed at baseline (Month 6) and after 3 months of intervention (Month 9)
Visual analogue scale is a psychometric measuring instrument designed to document cervical pain severity in individual subjects. It achieves a rapid (statistically measurable and reproducible) classification of symptom severity. A 100-mm long horizontal line with verbal descriptors is used to grade the amount of pain that a patient feels from no pain (left 0 mm) to an extreme amount of pain (right 100 mm).
次要结局
- Posture measured by angle of Kyphosis and angle of lordosis with a computerized device (SpinalMouse® )(Posture is assessed at Month 9 (end of study) after the washout period and the cross over 3 months intervention)
- Neck Disability Index(Neck disability is assessed at Month 9 (end of study) after the washout period and the cross over 3 months intervention)
- Pain Catastrophizing Scale(Catastrophizing is assessed at Month 9 (end of study) after the washout period and the cross over 3 months intervention)
研究者
Merce AVELLANET
Head of Rehabilitation Department - Adjunct professor
University of Andorra