Comparison of Somatosensory Exercise Versus Endurance-strength Exercise in Patients With Chronic Neck Pain: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain change
研究概览
简要总结
Aim: To compare the effects of somatosensory exercise vs endurance-strength exercise on the deep cervical flexor muscles on pain and perceived disability in patients with chronic neck pain.
Study design: Protocol of a clinical trial, controlled, parallel and a blinded assessor.
Population: Subjects aged 18 to 65 years with neck pain of 3 or more months of evolution.
详细描述
The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. A total of 60 subjects with nonspecific chronic neck pain will be selected and randomly assigned into two intervention groups. The first group will perform a somatosensory exercise program and a second group will perform activation and endurance-strength exercises of the deep cervical flexors. The duration of the intervention will be 8 weeks, with 6 sessions of physical therapy and daily home exercise. The variables pain, pressure pain threshold, disability, endurance-strength, proprioception, quality of life, kinesiophobia, quality of sleep and depression will be analyzed. Measurements will be taken pre-treatment, post-treatment and a follow-up at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The evaluator will not know to which treatment group each belongs.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of age between 18 and 65 years
- •Neck pain of 3 or more months of evolution
排除标准
- •Cervical Disability Index less than 15/50
- •Infection
- •Oncological processes
- •Neck or arm surgery
- •Neck or arm trauma
- •Positive neurological signs
- •Rheumatic diseases
研究组 & 干预措施
Somatosensory training
It consists of head relocation exercises, eye tracking, gaze stability and eye-head coordination. It requires the use of special material, the pupillary glasses allow the gaze to be fixed by restricting peripheral vision and the laser pointer provides visual feedback on the positioning of the head.
干预措施: Therapeutic exercises (Other)
Endurance-strength training
It consists of low-load training of the craniocervical flexor muscles. This exercise is specific for the deep cervical flexor muscles, while seeking minimal activation of the superficial flexor muscles. This training consists of 5 phases, starting with a pressure of 20 mmHg, progressively increasing 2 mmHg in each phase.
干预措施: Therapeutic exercises (Other)
结局指标
主要结局
Pain change
时间窗: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
To assess pain, the Visual Analogue Scale will be used, which consists of a 10-centimeter horizontal line, at whose ends is the maximum expression of a symptom.
Disability change
时间窗: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Disability will be assessed using the validated Spanish version of the Cervical Disability Index. Its range score is 0-50, higher values mean greater disability.
次要结局
- Pressure Pain Threshold change(Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.)
- Endurance of craniocervical flexion change(Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.)
- Proprioception change(Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.)
- Kinesiophobia change(Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.)
- Quality of life change(Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.)
- Depression change(Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.)
- Sleep quality change(Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.)
研究者
Alexander Achalandabaso
Clinical professor
University of Jaén