Spinal Kinematics Variability

Completed

• Conditions: Chronic Low Back Pain

• Registration Number: NCT03507296
• Lead Sponsor: Haute Ecole de Santé Vaud

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.

Study Timeline

• Study First Submitted: 2018-03-14
• Study Start: 2018-04-13
• Study First Submitted QC: 2018-04-24
• Study First Posted: 2018-04-25
• Primary Completion: 2020-09-25
• Study Completion: 2020-09-25
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-08
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spinal kinematics	Change between measure 1 and measure 3 (day 7)	Range of movement at the lower lumbar, upper lumbar, lower thoracic and upper thoracic joints
Trunk muscle activity	Change between measure 1 and measure 3 (day 7)	Surface electromyography of paraspinal, rectus abdominis and external obliques muscles

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Lausanne Hospitals; 🇨🇭 Lausanne, Vaud, Switzerland