Effectiveness of an Exercise-based Telerehabilitation Program for Police Officers and Firefighters With Chronic Non-specific Low Back 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
- 66
- 试验地点
- 2
- 主要终点
- Pain Intensity at post-treatment follow-up
研究概览
简要总结
The aim of this clinical trial is to develop and test the effectiveness of a smartphone app-based self-management program based on exercise and pain education for police officers and firefighters with chronic low back pain.
详细描述
Low back pain is the leading cause of year lived with disability worldwide. Workers exposed to physically demanding activities and inappropriate postures, such as those performed by police officers and firefighters, are highly affected by chronic low back pain. Smartphone app-based self-managed interventions have been shown to be an alternative for chronic non-specific low back pain treatment. However, there is still little research on the development and testing of remotely-delivered programs for the management of chronic low back pain, especially in police and fire professionals. The aim of this clinical trial is to develop and test the effectiveness of a smartphone app-based self-management program based on exercise and pain education for police officers and firefighters with chronic low back pain.
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 60 years
- •Chronic low back pain (defined as pain lasting more than 12 weeks)
- •Chronic low back pain of at least 3 points in a 0 to 10 Pain Numerical Rating Scale
- •Own a smartphone with internet access and email account
- •Police officer (federal, federal highway, civil or military) or military firefighter working in the State of Rio Grande do Sul
排除标准
- •Present neurological symptoms (nerve root compromise, or sensation deficits)
- •Present serious spinal diseases (e.g., fracture, tumor, inflammatory, autoimmune, and infectious diseases)
- •Present serious cardiovascular and metabolic diseases (e.g., coronary heart disease, cardiac insufficiency, decompensated diabetes)
- •Recent spine surgery (over the last 12 months) or scheduled to undergo surgery in the next six months, or pregnancy
- •History of physical therapy treatment for low back pain or physical exercise (strength training for core muscles, Pilates, yoga) current or within the last 3 months
- •If have any contraindication to exercise:
- •We will perform a pre-screening for physical activity participation at baseline using the Physical Activity Readiness Questionnaire (PAR-Q) Portuguese version to rule out any contraindication to participate in physical activity
研究组 & 干预措施
App-Based Pain Education and Exercise
Patients allocated to the experimental group will receive a login and password for individual access to the smartphone app designed for the study. The app's content for this group will include three components: 1) a physical exercise program of 8 weeks; 2) weekly messages; and 3) an online booklet. The exercise component will include 8 weeks of training, with two sessions per week of core strengthening exercises. The app will provide illustrations, with animated images (GIFs), descriptions and audios of how to perform each exercise. The message component will provide eight messages (one per week), which will have their contents taken from the online booklet. Messages will include information about the benefits of exercise, motivation, and positive messages about coping with pain. The online booklet will contain general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of exercises.
干预措施: App-Based Pain Education and Exercise (Other)
Online Booklet
Patients allocated to the control group will receive a login and password for individual access to the smartphone app designed for the study. The app's content for this group will include two components: 1) an online booklet; and 2) weekly messages. The online booklet will contain general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of exercises. The message component will provide eight messages (one per week), which will have their contents taken from the online booklet. Messages will include information about the benefits of exercise, motivation, and positive messages about coping with pain.
干预措施: Online booklet (Other)
结局指标
主要结局
Pain Intensity at post-treatment follow-up
时间窗: Post-treatment follow-up (8 weeks)
The primary outcome will be pain intensity measured using the Pain Numerical Rating Scale, a numerical scale of 11 domains, where 0 indicates no pain and 10 indicates maximum pain intensity.
Disability at post-treatment follow-up
时间窗: Post-treatment follow-up (8 weeks)
The primary outcome will be disability measured using the Roland Morris Disability Questionnaire, a 24-item questionnaire that assesses normal activities of daily living, where a higher score indicating a higher level of disability.
次要结局
- Disability at 4 months follow-up(4 months follow-up)
- Health-Related Quality of Life(The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.)
- Depression, Anxiety and Stress(The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.)
- Sleep quality(The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.)
- Muscular activation of flexor and extensor muscles(The outcome will be evaluated after the treatment period (8 weeks).)
- Isometric muscular endurance of the trunk extensor(The outcome will be evaluated after the treatment period (8 weeks).)
- Pain intensity at 4 months follow-up(4 months follow-up)
- Self-efficacy(The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.)
- Work ability(The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.)
- Adverse Effects(The outcome will be evaluated after the treatment period (8 weeks) and after 4 months of randomization of each subject.)
- Maximum isometric strength of the trunk extensor and flexor muscles(The outcome will be evaluated after the treatment period (8 weeks).)
- Isometric muscular endurance of the trunk flexors(The outcome will be evaluated after the treatment period (8 weeks).)
研究者
Cristine Lima Alberton
PhD
Federal University of Pelotas
