An observational study in Chronic Low Back Pain, sponsored by Haute Ecole de Santé Vaud. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-01-11.
Sponsored by Haute Ecole de Santé Vaud · Observational
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.
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.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's enrollment of 71 is below the median of 100 across 481 observational studies indexed under Low Back Pain.
Browse Low Back Pain studies →Haute Ecole de Santé Vaud is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
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Patients with chronic low back pain for more than three months participating to a 3 weeks' multidisciplinary rehabilitation program
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with chronic low back pain participating to a 3 weeks Multidisciplinary rehabilitation program
Other: Multidisciplinary rehabilitation program
The multimodal rehabilitation program (MRP) based at the University Hospital 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 MRP includes physiotherapy treatments, aiming at improving cardio-vascular endurance, long-term physical activity adherence, proprioception, mobility and strength. Additionally, occupational therapy is mainly focussed on reassuring patients that spinal movements are safe. Finally, psychologists are involved in the MRP to discuss the meaning of LBP, the psychological implications and the patient's resources.
Spinal kinematics
Range of movement and angular velocity at the lower lumbar, upper lumbar, lower thoracic and upper thoracic joints
Time frame: Change between baseline and week 4
Trunk muscle activity
Surface electromyography of paraspinal and abdominal muscles
Time frame: Change between baseline and week 4
Pain intensity
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).
Time frame: Change between baseline and week 4
Disability
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).
Time frame: Change between baseline and week 4
Kinesiophobia
Tampa Scale of Kinesiophobia. The total score is between 17 (no kinesiophobia) to 68 (high level of kinesiophobia).
Time frame: Change between baseline and week 4
Pain-related fear
Photograph Series of Daily Activities. The score is from 0 (no pain-related fear) to 100 (high levels of pain related fear)
Time frame: Change between baseline and week 4
Fear
Fear scale measured before each movement or activity. Score between 0 (no fear) and 10 (high levels of fear).
Time frame: Change between baseline and week 4
Pain expectation
Pain expectation scale before each movement or activity. Score between 0 (no pain expected) and 10 (high levels of pain expected).
Time frame: Change between baseline and week 4
Disability (ODI)
Oswestry Disability Questionnaire. Score between 0 (no disability) and 100.
Time frame: Baseline (Day 0), week 4, Month 3, Month 12
Disability
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).
Time frame: Month 3, Month 12
Pain intensity
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).
Time frame: Month 3, Month 12
Catastrophizing
Pain Catastrophizing Scale. Score between 0 and 52 (high levels of catastrophizing).
Time frame: Baseline (Day 0), week 4, Month 3, Month 12
Back Pain Attitudes
Back Pain Attitudes Questionnaires. Score between 34 (positive attitudes and beliefs) and 170 (negative attitudes and beliefs)
Time frame: Baseline (Day 0), week 4, Month 3, Month 12
Kinesiophobia
Tampa Scale of Kinesiophobia. The total score is between 17 (no kinesiophobia) to 68 (high level of kinesiophobia).
Time frame: Month 3, Month 12
Level of Bothersomeness
Bothersomeness mesaured with a scale with one question scored from 0 to 4 (Dunn et al, Spine, 2005).
Time frame: Baseline (Day 0), week 4, Month 3, Month 12
Level of Worry about back pain
Worry numeric scale. Worry about current back pain is scored from 0 (no worry) to 10 (extremely worried).
Time frame: Baseline (Day 0), week 4, Month 3, Month 12
Work ability
Work ability. Is back pain limiting the ability to work normally (answer: Yes or No)?
Time frame: Baseline (Day 0), Month 3, Month 12
Patient Global Impression of Change
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?"
Time frame: Month 3, Month 12
Fear of moving
Is there any movement or activity that you don't do or do differently because they are harmful or dangerous for your back ?
Time frame: Baseline (Day 0)
Localization of pain
Body chart with localization of pain
Time frame: Baseline (Day 0)
Aggravating factors
Which movements or activity increase pain ?
Time frame: Baseline (Day 0)
Medication
Number of medication for low back pain
Time frame: Baseline (Day 0), week 4, Month 3, Month 12
Plan to share: Undecided
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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