Effectiveness of Therapeutic Exercise Controlled Through App Adding Face-to-face Supervision Executed by Physical Therapist in the Subacute and Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Number of participants with improve intensity of Low Back pain based in Pain Intensity- Numerical Rating Scale
研究概览
简要总结
Low Back Pain (LBP) is one of the most usual illness in our society. Therapeutic Exercise (TE) has been shown the most effective and cheaper treatment in patients suffering LBP, but the lack of engagement to the therapeutic exercise programs is related with later acute LBP and chronic situations, despite symptoms slightly improve.
The value of personalized therapeutic exercised programs in patients suffering LBP has been shown nowadays, improving symptomatology and quality of life.
New technologies help patients to engage more in treatment, while time that health education make people "active patients".
The aim of the study is to evaluate the effectiveness of a Home Therapeutic Exercise Program (HTEP) based in an app with McGill's exercised adding 6 face-to-face sessions every 15 days with a physical therapist .
详细描述
INTRODUCTION
Low back pain is defined as pain and discomfort, localized below the costal margin and above the inferior gluteal folds, with or without leg pain . Sub-acute low back pain as low back pain persisting between 6 and 12 weeks; chronic low back pain as low back pain persisting for 12 weeks or more. It is not usual define specific causes of LBP, no more than 15 % patients have a define cause. Non-specific low back pain is defined as low back pain not attributed to recognizable, known specific pathology (e.g. infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome or cauda equina syndrome).
LBP is one of main world health problems, 23.9 % world citizens suffer LBP over a month in their life. World aging foresee this percentage will increase more in women from 40 to 80 years old. In 2017 LBP was an important men and women chronic health problem in Spain, the second cause more important in women with 23.5 % Spanish women suffering it and the third one in men with 15.8 % Spanish men suffering it. LBP is also the most important cause of work absenteeism with general back pain and migraine.
LBP is related with sedentary lifestyle. Recurrent low back pain is usual. There are several studies searching LBP's risks and LBP's risks factors but they did not show a clear reason.
Studies about app beef up treatment engagement and treatment effectiveness. Last studies about engagement and health improvement using app had shown positive results in diabetes patients, hypertension patients, heart pathology or daily pain management without help (for example Keele Pain Recorder app).
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
- Double (Investigator, Outcomes Assessor)
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
- •≥ 18 and ≤ 65 years old.
- •Suffering low back pain.
- •In a subacute and chronic phase
排除标准
- •Non signature of the informed consent
- •Red Flags are risk factors detected in low back pain patients' past medical history and symptomatology and are associated with a higher risk of serious disorders causing low back pain compared to patients without these characteristics.
- •Yellow Flags are psychosocial factors that increase the risk of developing, or perpetuating chronic pain and long-term disability (including) work-loss associated with low back pain.
- •Pregnancy and lactation
- •Serious trauma or back surgery before the study
- •Illness or dysfunction of balance
- •Visual dysfunction.
- •Neurological illness, dysfunction or pain.
- •Inability to stand up and sit without help
- •Inability to read, understand and complete questionnaires, read and understand a brochure, or understand and follow verbal instructions (e.g. Illiteracy, dementia or blindness) or read, understand and use an app
结局指标
主要结局
Number of participants with improve intensity of Low Back pain based in Pain Intensity- Numerical Rating Scale
时间窗: 12 weeks treatment
Intensity of low back pain (measured by Pain Intensity- Numerical Rating Scale ( PI-NRS)) at rest. It will be valued three times with 1 min between the three valuations. 1 item, minimum value 0 and maximum value 10, and 10 is the worse value and the average will be recorded.
次要结局
- Number of participants with improve degree of quality of life based in Spanish version of the Short Form Health Survey(At baseline, 4 weeks treatment, 8 weeks treatmentment,12 weeks treatment and 2 months post-treatment)
- Number of participants with improve degree of Low Back pain disability based in Oswestry test(At baseline, 4 weeks treatment, 8 weeks treatmentment,12 weeks treatment and 2 months post-treatment)
- Level of physical therapy intervention satisfaction based in Spanish version of the Patient Satisfaction Questionnaire(12 weeks treatment)