Spinal Kinematics in Chronic Low Back Pain: a Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Pain-related fear
研究概览
简要总结
Chronic low back pain (CLBP) is one of the most frequent causes for limitations in daily, leisure and work-related activities. Although alterations in spinal motor behavior were consistently reported in CLBP patients, it remains unclear how improvements in spinal motor behavior through rehabilitation treatment affect pain and disability. Psychological factors, such as pain-related fear, were suggested as a possible main cause of spinal motor behavior in CLBP and better understanding their relationships with kinematic and muscle activity alterations is required to enhance care, particularly physiotherapy. Therefore, this study will test CLBP patients before and after a 3 week rehabilitation program to test the hypotheses that: 1) improvements in spinal motor behavior (kinematics and trunk muscle activity) are associated with decreased pain and disability; 2) decrease in pain-related fear is associated with spinal motor behavior improvements.
详细描述
The research project is a prospective observational cohort study. CLBP patients participating to a 3 weeks' multimodal rehabilitation program will be tested in the motion analysis laboratory before (T1) and after (T2) the program. This program is an intensive 3-weeks multidisciplinary rehabilitation program. Patients come daily for individual and group treatments, with a total of 100 hours of intervention during 3 weeks. The program includes physiotherapy treatments, occupational therapy, psychologists encounters and education session. The programs encompasses a multidimensional view of chronic low back pain. Therefore, this setting is a unique opportunity to improve our understanding of the role of motor behavior alterations in CLBP because it will allow connecting changes in spinal kinematics and muscle activity with changes in pain, disability and pain-related fear.
This project has two aims in relation to motor behavior in patients with CLBP:
The first aim is to analyse the relationship between changes in spinal kinematics and changes in pain and disability during and after a multimodal rehabilitation program. First, changes in spinal kinematics and muscle activity between T1 and T2 will be calculated. The relationship between these changes and changes in pain and disability during the program will be tested. Pain and disability will be also measured at 3 months (T3) and one year (T4) after the program, which will allow to further analyze the relationship between spinal motor behavior and pain and disability.
The second aim concerns the role of pain-related fear, and its decrease, in spinal motor behavior alterations. Consequently, the second aim is to analyse if changes in pain-related fear are associated with changes in spinal kinematics during a multimodal rehabilitation program.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •non-specific low back pain (pain from lower ribs to gluteal folds) for more than 3 months
- •sufficient French level to understand the instructions for the tests, the information sheet, the consent form and the questionnaires
- •both male and female adults will be included
- •age more than 18 years old.
排除标准
- •pregnancy
- •skin allergy to tape
- •body mass index (BMI) above 32
- •any sign of specific low back pain such as the presence of infection, rheumatologic or neurological diseases, spinal fractures, any known important spinal deformities, previous back surgery that limits spinal mobility, tumours
- •high level of pain at the time of experiment that prevents repeated movements (severity and irritability)
- •other concomitant pain or condition that could compromise the evaluation of spinal kinematics.
结局指标
主要结局
Pain-related fear
时间窗: Change between baseline and week 4
Photograph Series of Daily Activities. The score is from 0 (no pain-related fear) to 100 (high levels of pain related fear)
Kinesiophobia
时间窗: Change between baseline and week 4
Tampa Scale of Kinesiophobia. The total score is between 17 (no kinesiophobia) to 68 (high level of kinesiophobia).
Spinal kinematics
时间窗: Change between baseline and week 4
Range of movement and angular velocity at the lower lumbar, upper lumbar, lower thoracic and upper thoracic joints
Disability
时间窗: Change between baseline and week 4
Disability will be quantified by the Patient Specific Functional Scale. The scale assessed three relevant activities for the patient and scores each activity between 0 (impossible to realize the activity) to 10 (capable of doing the activity normally).
Trunk muscle activity
时间窗: Change between baseline and week 4
Surface electromyography of paraspinal and abdominal muscles
Pain intensity
时间窗: Change between baseline and week 4
Pain intensity will be quantified by the 11-point Numeric Pain Rating Scale. The scale range from 0 (no pain at all) to 10 (worst pain).
Fear
时间窗: Change between baseline and week 4
Fear scale measured before each movement or activity. Score between 0 (no fear) and 10 (high levels of fear).
Pain expectation
时间窗: Change between baseline and week 4
Pain expectation scale before each movement or activity. Score between 0 (no pain expected) and 10 (high levels of pain expected).
次要结局
- Disability (ODI)(Baseline (Day 0), week 4, Month 3, Month 12)
- Pain intensity(Month 3, Month 12)
- Kinesiophobia(Month 3, Month 12)
- Disability(Month 3, Month 12)
- Back Pain Attitudes(Baseline (Day 0), week 4, Month 3, Month 12)
- Level of Worry about back pain(Baseline (Day 0), week 4, Month 3, Month 12)
- Work ability(Baseline (Day 0), Month 3, Month 12)
- Patient Global Impression of Change(Month 3, Month 12)
- Catastrophizing(Baseline (Day 0), week 4, Month 3, Month 12)
- Level of Bothersomeness(Baseline (Day 0), week 4, Month 3, Month 12)