Digital Training Interventions for Low Back Pain - RCT With Longitudinal Evaluation of Clinical Outcome Measures and MRI Examinations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Difference in T2 (transverse relaxation time)
研究概览
简要总结
The patients will be clinically examined, as well as evaluated with Patient Reported Outcome Measures (PROMs) and Magnet Resonance Imaging (MRI) at baseline and at follow-ups.
详细描述
The overall aim is to evaluate two different types of digital training interventions supervised by physiotherapists compared to daily physical activity in terms of clinical, imaging-based and patient-reported outcome in patients with low back pain. Furthermore, to evaluate whether new diagnostic MRI methods can identify longitudinal spine tissue changes and to analyse if there is an exercise-related difference.
Patients seeking primary health care for lower back pain will be randomized to three groups. The patients will be clinically examined, assessed with Magnet Resonance Imaging (MRI) and Patient Reported Outcome Measures (PROMs) will be evaluated at baseline and at follow-ups.
A detailed description of the study protocol, see attached document.
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
- None
盲法说明
Both patients and physiotherapists know what intervention group they were randomized to.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low back pain> 3 months
- •Age 18-50 years
- •Access to computer/tablet/mobile phone
排除标准
- •Inadequate Swedish as the language is an obstacle to be able to fully understand written and oral information regarding the project and to follow training instructions
- •Other ongoing treatment/exercise for their low back pain
- •Patients with radiating leg pain and neurological symptoms where herniated discs are suspected
- •Previous back/neck surgery
- •Pregnancy
- •Diagnosed systematic diseases engaging the spine as rheumatoid arthritis, ankylosing spondylitis
- •Factors that prevent an MRI examination, such as claustrophobia, metal implants, etc.
结局指标
主要结局
Difference in T2 (transverse relaxation time)
时间窗: 12 months compared to baseline and 6 months
MRI can characterize tissue by two different relaxation times, T1 and T2
Change in Patient-reported pain
时间窗: 12 months compared to baseline and 6 months
Visual Analog Scale (VAS) registration 0 (=no pain)-100 (=worst pain), where In the minimal clinically significant change has been estimated as 11 points on a 100-point scale
次要结局
- Change in Functional tests (Åstrand ergometer test)(12 months compared to baseline and 6 months)
- Change in PROM (Generalized Self-Efficacy Scale (GSES))(12 months compared to baseline and 6 months)
- Change in Clinical outcomes (Walking on heels)(12 months compared to baseline and 6 months)
- Change in Functional tests (Prone-bridge test)(12 months compared to baseline and 6 months)
- Change in Clinical outcomes (Muscle hypotrophy)(12 months compared to baseline and 6 months)
- Change in PROM (Oswestry Low Back Disability Index)(12 months compared to baseline and 6 months)
- Change in clinical outcomes (Standing inspection)(6 months compared to baseline)
- Change in clinical outcomes (Standing side-to-side symmetry)(6 months compared to baseline)
- Change in Clinical outcomes (Walking on toes)(12 months compared to baseline and 6 months)
- Change in Functional tests (Sit-to-stand test)(12 months compared to baseline and 6 months)
- Change in PROM (Hospital Anxiety and Depression Scale (HAD))(12 months compared to baseline and 6 months)
- Change in Clinical outcomes (Standing inspection)(12 months compared to baseline and 6 months)
- Change in Clinical outcomes (Standing side-to-side symmetry)(12 months compared to baseline and 6 months)
- Change in PROM (Standardized National standardized questions on physical activity)(12 months compared to baseline and 6 months)
- Change in PROM (The 5-level EQ-5D version (EQ-5D-5L))(12 months compared to baseline and 6 months)
- Change in PROM (Tampa Scale of Kinesiophobia (TSK))(12 months compared to baseline and 6 months)
研究者
Ninni Sernert
Professor
Vastra Gotaland Region