Clinical trial NCT03507296: Spinal Kinematics Variability
Official title: Spinal Kinematics Variability in Healthy Subjects and Patients With Chronic Low Back Pain in Different Functional Activities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low Back Pain
Lead sponsor: Haute Ecole de Santé Vaud
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic low back pain patients

Brief summary: This study will test the within and between day variability of spinal kinematics and trunk muscle activity in healthy subjects and chronic low back pain patients during various daily-life activities.

Detailed description: This study will test the within and between day variability of spinal kinematics and trunk muscle activity in healthy subjects and chronic low back pain patients during various daily-life activities. Participants will come twice to the motion laboratory. During the first session, participants will first perform different functional activities (V1), such as sit-to-stand, gait, lifting tasks, stepping up. Their spinal kinematics will be measured with a camera-based system (VICON) using a multi-segment spinal model and trunk muscles activity will be recorded with surface electromyography. After a break, participants will have to perform all the functional activities a second time (V2). These two measures (V1 and V2) will be used to determine the within day variability of spinal kinematics. Finally, all participants will come one week later (V3) to repeat all the measurements to determine the between day variability.

Eligibility criteria: Inclusion Criteria:

* sufficient French level to understand the instructions for the tests, the information sheet, the consent form and the questionnaires
* All chronic low back pain patients should present with non-specific low back pain (pain from lower ribs to gluteal folds) for more than 3 months.

Exclusion Criteria:

* pregnancy
* body mass index (BMI) that is above 32
* patients should not have any sign of specific low back pain such as the presence of infection, rheumatological 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 measure 1 and measure 2 (30 minutes later)
measure: Trunk muscle activity
timeFrame: Change between measure 1 and measure 2 (30 minutes later)
measure: Spinal kinematics
timeFrame: Change between measure 1 and measure 3 (day 7)
measure: Trunk muscle activity
timeFrame: Change between measure 1 and measure 3 (day 7)
Secondary outcomes:
measure: Pain intensity
timeFrame: Measure 1 (Day 0), Measure 3 (Day 7)
measure: Disability
timeFrame: Measure 1 (Day 0), Measure 3 (Day 7)
measure: Disability (ODI)
timeFrame: Measure 1 (Day 0), Measure 3 (Day 7).
measure: Kinesiophobia
timeFrame: Measure 1 (Day 0), Measure 3 (Day 7).
measure: Catastrophizing
timeFrame: Measure 1 (Day 0), Measure 3 (Day 7).
measure: Back Pain Attitudes Questionnaire
timeFrame: Measure 1 (Day 0), Measure 3 (Day 7).
measure: Fear
timeFrame: Measure 1 (Day 0), Measure 2 (Day 0), Measure 3 (Day 7).
measure: Pain expectation
timeFrame: Measure 1 (Day 0), Measure 2 (Day 0), Measure 3 (Day 7).
Other outcomes:
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.