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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02278549
Other study ID # MT001GC
Secondary ID
Status Completed
Phase N/A
First received October 27, 2014
Last updated October 26, 2015
Start date November 2014
Est. completion date June 2015

Study information

Verified date October 2015
Source Haute Ecole Cantonale Vaudoise de Santé
Contact n/a
Is FDA regulated No
Health authority Switzerland: Cantonal Office of Public Health
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 50 Years
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland University of Lausanne Hospitals Lausanne Vaud

Sponsors (3)

Lead Sponsor Collaborator
Haute Ecole Cantonale Vaudoise de Santé University of Brighton, University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

References & 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. — View Citation

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, Avon). 2013 Oct;28(8):866-72. doi: 10.1016/j.clinbiomech.2013.09.001. Epub 2013 Sep 9. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2012 May 10. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Score of disability Oswestry Disability Index. Outcome used primarily for description of the population and correlational analysis Participants will be measured once No
Secondary Score of kinesophobia Tampa Scale of kinesophobia. Outcome used primarily for description of the population and correlational analysis Participants will be measured once No
Secondary Score of risk of poor outcomes Start Back Tool. Outcome used primarily for description of the population and correlational analysis Participants will be measured once No
Secondary Pain intensity Numeric Pain Rating Scale (NPRS). Outcome used primarily for description of the population and correlational analysis Participants will be measured once No
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