Spinal Kinematics Variability

NCT03507296 | Completed

• 1 other identifier: VAR2017
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Pain intensity

  Measure 1 (Day 0), Measure 3 (Day 7)

• Disability

  Measure 1 (Day 0), Measure 3 (Day 7)

• Disability (ODI)

  Measure 1 (Day 0), Measure 3 (Day 7).

• Kinesiophobia

  Measure 1 (Day 0), Measure 3 (Day 7).

• Catastrophizing

  Measure 1 (Day 0), Measure 3 (Day 7).

Study Arms (2)

Chronic low back pain patients

Asymptomatic subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic low back pain patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haute Ecole de Santé Vaud: lead

Study Sites (1)

University of Lausanne Hospitals

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 27262182 BACKGROUND

• 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.

  PMID: 28716466 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: April 25, 2018
• Study Start: April 13, 2018
• Primary Completion: September 25, 2020
• Study Completion: September 25, 2020
• Last Updated: October 11, 2021

Record last verified: 2021-10

Locations

CH (1)