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Completed

NCT Number: NCT03507296

Spinal Kinematics Variability

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.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Lausanne Hospitals

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Spinal kinematics

    Time frame: 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

    Time frame: Change between measure 1 and measure 2 (30 minutes later)

    Surface electromyography of paraspinal, rectus abdominis and external obliques muscles

  3. Spinal kinematics

    Time frame: 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

    Time frame: Change between measure 1 and measure 3 (day 7)

    Surface electromyography of paraspinal, rectus abdominis and external obliques muscles

Secondary outcomes

  1. Pain intensity

    Time frame: 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

    Time frame: 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)

    Time frame: Measure 1 (Day 0), Measure 3 (Day 7).

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

  4. Kinesiophobia

    Time frame: 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

    Time frame: 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

    Time frame: Measure 1 (Day 0), Measure 3 (Day 7).

    Back Pain Attitudes Questionnaire. Score between 34 (positive attitudes) and 170 (negative attitudes)

  7. Fear

    Time frame: 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Haute Ecole de Santé Vaud

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 25, 2018
Registry last updated
Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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