NCT02278549

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 27, 2015

Status Verified

October 1, 2015

Enrollment Period

7 months

First QC Date

October 27, 2014

Last Update Submit

October 26, 2015

Conditions

Low Back Pain

Keywords

Spinal kinematics

Outcome Measures

Primary Outcomes (1)

  • Spinal kinematics

    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.

    Participants will be measured once

Secondary Outcomes (4)

  • Score of disability

    Participants will be measured once

  • Score of kinesophobia

    Participants will be measured once

  • Score of risk of poor outcomes

    Participants will be measured once

  • Pain intensity

    Participants will be measured once

Study Arms (2)

Asymptomatic

Individuals between 30 and 50 years old that have had no episode of low back pain in the last two years requiring medical attention

Patients with Low Back Pain

Individuals between 30 and 50 years old that present with non-specific low back pain for more than 3 months

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with recurrent low back pain (more than months in duration) recruited through physiotherapy practices and medical consultations in the area of Lausanne, Switzerland.

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lausanne Hospitals

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (7)

  • Cobian DG, Daehn NS, Anderson PA, Heiderscheit BC. Active cervical and lumbar range of motion during performance of activities of daily living in healthy young adults. Spine (Phila Pa 1976). 2013 Sep 15;38(20):1754-63. doi: 10.1097/BRS.0b013e3182a2119c.

    PMID: 23823575BACKGROUND

  • Crosbie J, Nascimento DP, Filho Rde F, Ferreira P. Do people with recurrent back pain constrain spinal motion during seated horizontal and downward reaching? Clin Biomech (Bristol). 2013 Oct;28(8):866-72. doi: 10.1016/j.clinbiomech.2013.09.001. Epub 2013 Sep 9.

    PMID: 24067874BACKGROUND

  • Dankaerts W, O'Sullivan P, Burnett A, Straker L. Differences in sitting postures are associated with nonspecific chronic low back pain disorders when patients are subclassified. Spine (Phila Pa 1976). 2006 Mar 15;31(6):698-704. doi: 10.1097/01.brs.0000202532.76925.d2.

    PMID: 16540876BACKGROUND

  • Lehman GJ. Biomechanical assessments of lumbar spinal function. How low back pain sufferers differ from normals. Implications for outcome measures research. Part I: kinematic assessments of lumbar function. J Manipulative Physiol Ther. 2004 Jan;27(1):57-62. doi: 10.1016/j.jmpt.2003.11.007.

    PMID: 14739876BACKGROUND

  • Marras WS, Ferguson SA, Gupta P, Bose S, Parnianpour M, Kim JY, Crowell RR. The quantification of low back disorder using motion measures. Methodology and validation. Spine (Phila Pa 1976). 1999 Oct 15;24(20):2091-100. doi: 10.1097/00007632-199910150-00005.

    PMID: 10543004BACKGROUND

  • Parkinson S, Campbell A, Dankaerts W, Burnett A, O'Sullivan P. Upper and lower lumbar segments move differently during sit-to-stand. Man Ther. 2013 Oct;18(5):390-4. doi: 10.1016/j.math.2013.02.001. Epub 2013 Mar 7.

    PMID: 23473753BACKGROUND

  • Wade M, Campbell A, Smith A, Norcott J, O'Sullivan P. Investigation of spinal posture signatures and ground reaction forces during landing in elite female gymnasts. J Appl Biomech. 2012 Dec;28(6):677-86. doi: 10.1123/jab.28.6.677. Epub 2012 May 10.

    PMID: 22661081BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Julien Favre, PhD

    University of Lausanne Hospitals

    STUDY DIRECTOR

  • Lucy Redhead, PhD

    University of Brighton

    STUDY DIRECTOR

  • Guillaume Christe, PT

    Haute Ecole de Santé Vaud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT

Study Record Dates

First Submitted

October 27, 2014

First Posted

October 30, 2014

Study Start

November 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 27, 2015

Record last verified: 2015-10

Locations

CH(1)