Feasibility and Impact of a Tele-rehabilitation Program in Patients With Chronic and Non-specific Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Changes in disability
研究概览
简要总结
Chronic neck pain has a high prevalence in developed countries, being one of the main causes of years lived with disability and deterioration of the quality of life. Telerehabilitation is presented as a resource capable of favoring, with its development and implementation, the transition to a universal and quality health service. The main objective of the study is to assess the change in disability produced by a telerehabilitation program (applied in the intervention group) in patients with chronic and nonspecific neck pain compared to the recommendation of home exercises (control group).
The study that will be carried out will be a controlled and randomized clinical trial (ECCA), single-blind, longitudinal and prospective with two groups (intervention group and control group). The main study variables that are intended to be analyzed pre and post intervention are disability, quality of life, pain, adherence, and depression and anxiety.
The study will take place between June 2020 and May 2021 in specialized physiotherapy clinics.
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 (Investigator)
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
- •People between 18 and 65 years of age
- •Neck pain of more than 3 months of evolution
- •Access and knowledge in the use of the internet
- •Complete the informed consent
排除标准
- •Previous trauma to the cervical region (such as whiplash)
- •Neck surgery
- •Osteoporosis
- •Arthritis
- •Cervical radiculopathy associated with externalized cervical hernia
- •Vertigo or vertebrobasilar insufficiency
- •Vertebral fracture
- •Fibromyalgia
- •Cognitive impairment
- •Psychiatric disorders.
结局指标
主要结局
Changes in disability
时间窗: Baseline, 8 weeks and 2 month after intervention.
Using the Neck Disability Index (NDI). It is made up of 10 items and each item is scored on a 6-point Likert scale (0 to 5), leading to a total score ranging from 0 to 50 (0 to 4 = no disability; 5 to 14 = mild disability; 15 to 24 = moderate disability; 25 to 34 = severe disability; and 35 to 50 = complete disability).
次要结局
- Changes in Kinesiophobia(Baseline, 8 weeks and 2 month after intervention.)
- Changes in the pain: Visual Analog Scale (VAS)(Baseline, 8 weeks and 2 month after intervention.)
- Adherence to treatment(At 4 and 8 weeks of treatment)
- Changes in the health-related quality of life(Baseline, 8 weeks and 2 month after intervention.)
- Changes in depression and anxiety(Baseline, 8 weeks and 2 month after intervention.)
- Pressure pain threshold(Baseline, 8 weeks and 2 month after intervention.)
研究者
Alexander Achalandabaso
Doctor of Health Sciences
University of Jaén