- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03499613
Spinal Kinematics in Chronic Low Back Pain
Spinal Kinematics in Chronic Low Back Pain: a Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Vaud
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Lausanne, Vaud, Switzerland, 1011
- University of Lausanne Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Chronic low back pain
Patients with chronic low back pain participating to a 3 weeks 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spinal kinematics
Time Frame: Change between baseline and week 4
|
Range of movement and angular velocity at the lower lumbar, upper lumbar, lower thoracic and upper thoracic joints
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Change between baseline and week 4
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Trunk muscle activity
Time Frame: Change between baseline and week 4
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Surface electromyography of paraspinal and abdominal muscles
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Change between baseline and week 4
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Pain intensity
Time Frame: 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).
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Change between baseline and week 4
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Disability
Time Frame: 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).
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Change between baseline and week 4
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Kinesiophobia
Time Frame: Change between baseline and week 4
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Tampa Scale of Kinesiophobia.
The total score is between 17 (no kinesiophobia) to 68 (high level of kinesiophobia).
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Change between baseline and week 4
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Pain-related fear
Time Frame: Change between baseline and week 4
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Photograph Series of Daily Activities.
The score is from 0 (no pain-related fear) to 100 (high levels of pain related fear)
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Change between baseline and week 4
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Fear
Time Frame: Change between baseline and week 4
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Fear scale measured before each movement or activity.
Score between 0 (no fear) and 10 (high levels of fear).
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Change between baseline and week 4
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Pain expectation
Time Frame: Change between baseline and week 4
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Pain expectation scale before each movement or activity.
Score between 0 (no pain expected) and 10 (high levels of pain expected).
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Change between baseline and week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disability (ODI)
Time Frame: Baseline (Day 0), week 4, Month 3, Month 12
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Oswestry Disability Questionnaire.
Score between 0 (no disability) and 100.
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Baseline (Day 0), week 4, Month 3, Month 12
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Disability
Time Frame: Month 3, Month 12
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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).
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Month 3, Month 12
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Pain intensity
Time Frame: Month 3, Month 12
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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).
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Month 3, Month 12
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Catastrophizing
Time Frame: Baseline (Day 0), week 4, Month 3, Month 12
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Pain Catastrophizing Scale.
Score between 0 and 52 (high levels of catastrophizing).
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Baseline (Day 0), week 4, Month 3, Month 12
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Back Pain Attitudes
Time Frame: Baseline (Day 0), week 4, Month 3, Month 12
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Back Pain Attitudes Questionnaires.
Score between 34 (positive attitudes and beliefs) and 170 (negative attitudes and beliefs)
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Baseline (Day 0), week 4, Month 3, Month 12
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Kinesiophobia
Time Frame: Month 3, Month 12
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Tampa Scale of Kinesiophobia.
The total score is between 17 (no kinesiophobia) to 68 (high level of kinesiophobia).
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Month 3, Month 12
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Level of Bothersomeness
Time Frame: Baseline (Day 0), week 4, Month 3, Month 12
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Bothersomeness mesaured with a scale with one question scored from 0 to 4 (Dunn et al, Spine, 2005).
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Baseline (Day 0), week 4, Month 3, Month 12
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Level of Worry about back pain
Time Frame: Baseline (Day 0), week 4, Month 3, Month 12
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Worry numeric scale.
Worry about current back pain is scored from 0 (no worry) to 10 (extremely worried).
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Baseline (Day 0), week 4, Month 3, Month 12
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Work ability
Time Frame: Baseline (Day 0), Month 3, Month 12
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Work ability.
Is back pain limiting the ability to work normally (answer: Yes or No)?
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Baseline (Day 0), Month 3, Month 12
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Patient Global Impression of Change
Time Frame: Month 3, Month 12
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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?"
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Month 3, Month 12
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fear of moving
Time Frame: Baseline (Day 0)
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Is there any movement or activity that you don't do or do differently because they are harmful or dangerous for your back ?
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Baseline (Day 0)
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Localization of pain
Time Frame: Baseline (Day 0)
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Body chart with localization of pain
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Baseline (Day 0)
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Aggravating factors
Time Frame: Baseline (Day 0)
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Which movements or activity increase pain ?
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Baseline (Day 0)
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Medication
Time Frame: Baseline (Day 0), week 4, Month 3, Month 12
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Number of medication for low back pain
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Baseline (Day 0), week 4, Month 3, Month 12
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Christe G, Redhead L, Legrand T, Jolles BM, Favre J. Multi-segment analysis of spinal kinematics during sit-to-stand in patients with chronic low back pain. J Biomech. 2016 Jul 5;49(10):2060-2067. doi: 10.1016/j.jbiomech.2016.05.015. Epub 2016 May 20.
- Christe G, Kade F, Jolles BM, Favre J. Chronic low back pain patients walk with locally altered spinal kinematics. J Biomech. 2017 Jul 26;60:211-218. doi: 10.1016/j.jbiomech.2017.06.042. Epub 2017 Jul 5. Erratum In: J Biomech. 2019 Jan 23;83:329.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LBPKINCOH2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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