Spinal Kinematics Variability

Spinal Kinematics Variability in Healthy Subjects and Patients With Chronic Low Back Pain in Different Functional Activities

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • University of Lausanne Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chronic low back pain patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Chronic low back pain patients
Asymptomatic subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spinal kinematics	Range of movement at the lower lumbar, upper lumbar, lower thoracic and upper thoracic joints	Change between measure 1 and measure 2 (30 minutes later)
Trunk muscle activity	Surface electromyography of paraspinal, rectus abdominis and external obliques muscles	Change between measure 1 and measure 2 (30 minutes later)
Spinal kinematics	Range of movement at the lower lumbar, upper lumbar, lower thoracic and upper thoracic joints	Change between measure 1 and measure 3 (day 7)
Trunk muscle activity	Surface electromyography of paraspinal, rectus abdominis and external obliques muscles	Change between measure 1 and measure 3 (day 7)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Measure 1 (Day 0), Measure 3 (Day 7)
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).	Measure 1 (Day 0), Measure 3 (Day 7)
Disability (ODI)	Oswestry Disability Questionnaire. Score between 0 (no disability) and 100.	Measure 1 (Day 0), Measure 3 (Day 7).
Kinesiophobia	Tampa Scale of Kinesiophobia. The total score is between 17 (no kinesiophobia) to 68 (high level of kinesiophobia).	Measure 1 (Day 0), Measure 3 (Day 7).
Catastrophizing	Pain Catastrophizing Scale. Score between 0 and 52 (high levels of catastrophizing).	Measure 1 (Day 0), Measure 3 (Day 7).
Back Pain Attitudes Questionnaire	Back Pain Attitudes Questionnaire. Score between 34 (positive attitudes) and 170 (negative attitudes)	Measure 1 (Day 0), Measure 3 (Day 7).
Fear	Fear scale measured before each movement or activity. Score between 0 (no fear) and 10 (high levels of fear).	Measure 1 (Day 0), Measure 2 (Day 0), Measure 3 (Day 7).
Pain expectation	Pain expectation scale before each movement or activity. Score between 0 (no pain expected) and 10 (high levels of pain expected).	Measure 1 (Day 0), Measure 2 (Day 0), Measure 3 (Day 7).

Collaborators and Investigators

• Sponsor: Haute Ecole de Santé Vaud

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): April 13, 2018
• Primary Completion (Actual): September 25, 2020
• Study Completion (Actual): September 25, 2020

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: April 24, 2018
• First Posted (Actual): April 25, 2018

Study Record Updates

• Last Update Posted (Actual): October 11, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: VAR2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No