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OpenTrials
Completed

NCT Number: NCT02278549

Comparison of Spinal Kinematics Between Asymptomatic Subjects and Patients With Low Back Pain

Low back pain (LBP) is a complex and common problem with major societal repercussions. Clinical evaluations, and especially functional assessments, are necessary for proper diagnosis and decisions on the most appropriate treatment. The assessment of lumbar kinematics has been frequently described. For instance, measures of range of motion (ROM), angular velocities and acceleration of the total lumbar spine (TLx) have demonstrated some differences between healthy subjects and LBP patients. However, recent evidence has suggested that models evaluating the TLx are insufficient. In fact, regional differences in kinematics have been described between the upper lumbar spine and the lower lumbar spine.

The aim of this study is to evaluate the differences in spinal kinematics between healthy subjects and LBP patients using a multi-segment model of the spine that allows regional analysis.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Lausanne Hospitals

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

A case-controlled study will be performed to compare asymptomatics subjects and patients with low back pain. ROM, angular velocities and coordination of the spine will be collected in a laboratory with a camera-based system (VICON). Subjects will have to perform normal ROM assessment in the three anatomical planes, as well as different functional activities such as sit to stand, step and walking. The measurement session will occur on one occasion for each participant.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Sufficient French level
  • BMI between 18 and 27
  • Non-specific low back pain for more than 3 months (pain provoked by movements, postures or activities)

Exclusion criteria

  • Pregnancy
  • Spondylolisthesis
  • Infection
  • Rheumatological or neurological diseases
  • Spinal fractures
  • Known spinal deformation (scoliosis, …)
  • Back surgery
  • Tumours
  • Radicular symptoms (with neurological signs). Pain irradiating in the lower limbs with decrease strength, sensitivity and reflex.
  • High level of pain (severity and irritability) at the time of experiment that prevents repeated movements.
  • Other concomitant pain or condition that could compromise the evaluation of lumbar kinematics.

Treatment and study plan

Primary outcomes

  1. Spinal kinematics

    Time frame: Participants will be measured once

    kinematics of the spine and pelvis will be measured with a camera-based system. Markers will be placed to have different segments of the spine (lower lumbar spine, upper lumbar spine, lower thoracic spine, upper thoracic spine). Variables such as range of motion, angular velocities or coordination (among others) will be measured.

Secondary outcomes

  1. Score of disability

    Time frame: Participants will be measured once

    Oswestry Disability Index. Outcome used primarily for description of the population and correlational analysis

  2. Score of kinesophobia

    Time frame: Participants will be measured once

    Tampa Scale of kinesophobia. Outcome used primarily for description of the population and correlational analysis

  3. Score of risk of poor outcomes

    Time frame: Participants will be measured once

    Start Back Tool. Outcome used primarily for description of the population and correlational analysis

  4. Pain intensity

    Time frame: Participants will be measured once

    Numeric Pain Rating Scale (NPRS). Outcome used primarily for description of the population and correlational analysis

Sponsors and collaborators

Lead sponsor

Haute Ecole de Santé Vaud

Other

Collaborators

  • University of Brighton
  • University of Lausanne Hospitals

Registry information

Official study title

Comparison of Spinal Kinematics Between Asymptomatic Subjects and Patients With Low Back Pain Using a Multi-segment Model

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 30, 2014
Registry last updated
Oct 27, 2015

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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