Spinal Kinematics Variability

Sponsor
Haute Ecole de Santé Vaud (Other)
Overall Status
Completed
CT.gov ID
NCT03507296
Collaborator
(none)
40
1
29.4
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Spinal Kinematics Variability in Healthy Subjects and Patients With Chronic Low Back Pain in Different Functional Activities
    Actual Study Start Date :
    Apr 13, 2018
    Actual Primary Completion Date :
    Sep 25, 2020
    Actual Study Completion Date :
    Sep 25, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Chronic low back pain patients

    Asymptomatic subjects

    Outcome Measures

    Primary Outcome Measures

    1. Spinal kinematics [Change between measure 1 and measure 2 (30 minutes later)]

      Range of movement at the lower lumbar, upper lumbar, lower thoracic and upper thoracic joints

    2. Trunk muscle activity [Change between measure 1 and measure 2 (30 minutes later)]

      Surface electromyography of paraspinal, rectus abdominis and external obliques muscles

    3. 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

    4. 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

    1. 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).

    2. 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).

    3. Disability (ODI) [Measure 1 (Day 0), Measure 3 (Day 7).]

      Oswestry Disability Questionnaire. Score between 0 (no disability) and 100.

    4. 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).

    5. Catastrophizing [Measure 1 (Day 0), Measure 3 (Day 7).]

      Pain Catastrophizing Scale. Score between 0 and 52 (high levels of catastrophizing).

    6. 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)

    7. 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).

    8. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Lausanne Hospitals Lausanne Vaud Switzerland 1011

    Sponsors and Collaborators

    • Haute Ecole de Santé Vaud

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Haute Ecole de Santé Vaud
    ClinicalTrials.gov Identifier:
    NCT03507296
    Other Study ID Numbers:
    • VAR2017
    First Posted:
    Apr 25, 2018
    Last Update Posted:
    Oct 11, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 11, 2021