Spinal Kinematics Variability

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03507296
• Other study ID #: VAR2017
• Status: Completed
• Start date: April 13, 2018
• Est. completion date: September 25, 2020

Study information

• Verified date: October 2021
• Source: Haute Ecole de Santé Vaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 25, 2020
• Est. primary completion date: September 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Locations

Country	Name	City	State
Switzerland	University of Lausanne Hospitals	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Haute Ecole de Santé Vaud

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Trunk muscle activity	Surface electromyography of paraspinal, rectus abdominis and external obliques muscles	Change between measure 1 and measure 2 (30 minutes later)
Primary	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)
Primary	Trunk muscle activity	Surface electromyography of paraspinal, rectus abdominis and external obliques muscles	Change between measure 1 and measure 3 (day 7)
Secondary	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)
Secondary	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)
Secondary	Disability (ODI)	Oswestry Disability Questionnaire. Score between 0 (no disability) and 100.	Measure 1 (Day 0), Measure 3 (Day 7).
Secondary	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).
Secondary	Catastrophizing	Pain Catastrophizing Scale. Score between 0 and 52 (high levels of catastrophizing).	Measure 1 (Day 0), Measure 3 (Day 7).
Secondary	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).
Secondary	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).
Secondary	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).