Clinical trial NCT03499613: Spinal Kinematics in Chronic Low Back Pain
Official title: Spinal Kinematics in Chronic Low Back Pain: a Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low Back Pain
Keywords: Movement analysis
Spinal kinematics
Muscle activity
Pain-related fear
Rehabilitation
Spine
Lead sponsor: Haute Ecole de Santé Vaud
Sponsor class: OTHER
Collaborators: name: University of Lausanne Hospitals
name: University of Lausanne
First posted: 2018-04-17
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic low back pain for more than three months participating to a 3 weeks' multidisciplinary rehabilitation program

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Spinal kinematics
timeFrame: Change between baseline and week 4
measure: Trunk muscle activity
timeFrame: Change between baseline and week 4
measure: Pain intensity
timeFrame: Change between baseline and week 4
measure: Disability
timeFrame: Change between baseline and week 4
measure: Kinesiophobia
timeFrame: Change between baseline and week 4
measure: Pain-related fear
timeFrame: Change between baseline and week 4
measure: Fear
timeFrame: Change between baseline and week 4
measure: Pain expectation
timeFrame: Change between baseline and week 4
Secondary outcomes:
measure: Disability (ODI)
timeFrame: Baseline (Day 0), week 4, Month 3, Month 12
measure: Disability
timeFrame: Month 3, Month 12
measure: Pain intensity
timeFrame: Month 3, Month 12
measure: Catastrophizing
timeFrame: Baseline (Day 0), week 4, Month 3, Month 12
measure: Back Pain Attitudes
timeFrame: Baseline (Day 0), week 4, Month 3, Month 12
measure: Kinesiophobia
timeFrame: Month 3, Month 12
measure: Level of Bothersomeness
timeFrame: Baseline (Day 0), week 4, Month 3, Month 12
measure: Level of Worry about back pain
timeFrame: Baseline (Day 0), week 4, Month 3, Month 12
measure: Work ability
timeFrame: Baseline (Day 0), Month 3, Month 12
measure: Patient Global Impression of Change
timeFrame: Month 3, Month 12
Other outcomes:
measure: Fear of moving
timeFrame: Baseline (Day 0)
measure: Localization of pain
timeFrame: Baseline (Day 0)
measure: Aggravating factors
timeFrame: Baseline (Day 0)
measure: Medication
timeFrame: Baseline (Day 0), week 4, Month 3, Month 12
Locations:
city: Lausanne
country: Switzerland
facility: University of Lausanne Hospitals
state: Vaud
Study officials:
References:
citation: 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.
citation: 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.