Spinal Kinematics in Chronic Low Back Pain
- Conditions
- Chronic Low Back Pain
- Interventions
- Other: Multidisciplinary rehabilitation program
- Registration Number
- NCT03499613
- Lead Sponsor
- Haute Ecole de Santé Vaud
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Chronic low back pain Multidisciplinary rehabilitation program Patients with chronic low back pain participating to a 3 weeks Multidisciplinary rehabilitation program
- Primary Outcome Measures
Name Time Method Pain-related fear 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 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 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 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 Change between baseline and week 4 Surface electromyography of paraspinal and abdominal muscles
Pain intensity 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 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 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).
- Secondary Outcome Measures
Name Time Method Disability (ODI) Baseline (Day 0), week 4, Month 3, Month 12 Oswestry Disability Questionnaire. Score between 0 (no disability) and 100.
Pain intensity Month 3, Month 12 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).
Kinesiophobia Month 3, Month 12 Tampa Scale of Kinesiophobia. The total score is between 17 (no kinesiophobia) to 68 (high level of kinesiophobia).
Disability Month 3, Month 12 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).
Back Pain Attitudes Baseline (Day 0), week 4, Month 3, Month 12 Back Pain Attitudes Questionnaires. Score between 34 (positive attitudes and beliefs) and 170 (negative attitudes and beliefs)
Level of Worry about back pain Baseline (Day 0), week 4, Month 3, Month 12 Worry numeric scale. Worry about current back pain is scored from 0 (no worry) to 10 (extremely worried).
Work ability Baseline (Day 0), Month 3, Month 12 Work ability. Is back pain limiting the ability to work normally (answer: Yes or No)?
Patient Global Impression of Change Month 3, Month 12 This measure is a single-item rating by participants of their improvement with treatment on a 7-point scale that ranges from 'very much improved' (3 points) to 'very much worse' (-3 points) with 'no change' as the mid-point (0 points). The patient will answer this question: "With respect to your low back pain how would you describe yourself now, compared to before the start of the rehabilitation program you did at the University Hospital?"
Catastrophizing Baseline (Day 0), week 4, Month 3, Month 12 Pain Catastrophizing Scale. Score between 0 and 52 (high levels of catastrophizing).
Level of Bothersomeness Baseline (Day 0), week 4, Month 3, Month 12 Bothersomeness mesaured with a scale with one question scored from 0 to 4 (Dunn et al, Spine, 2005).
Trial Locations
- Locations (1)
University of Lausanne Hospitals
🇨🇭Lausanne, Vaud, Switzerland