Low Back PainNCT02278549
Comparison of Spinal Kinematics Between Asymptomatic Subjects and Patients With Low Back Pain
An observational study of Low Back Pain, run by Haute Ecole de Santé Vaud at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2014to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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)
Who cannot join
- Pregnancy
- Spondylolisthesis
- Infection
- Rheumatological or neurological diseases
- Spinal fractures
- Known spinal deformation (scoliosis, …)
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Lausanne Hospitals
Lausanne, Canton of Vaud, 1011
About this study
Official title: Comparison of Spinal Kinematics Between Asymptomatic Subjects and Patients With Low Back Pain Using a Multi-segment Model
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.
Read the detailed 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.
- Conditions
- Low Back Pain
- Keywords
- Spinal kinematics
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be measured once
Secondary outcomes (4)
Score of disability
Oswestry Disability Index. Outcome used primarily for description of the population and correlational analysis
Measured: Participants will be measured once
Score of kinesophobia
Tampa Scale of kinesophobia. Outcome used primarily for description of the population and correlational analysis
Measured: Participants will be measured once
Score of risk of poor outcomes
Start Back Tool. Outcome used primarily for description of the population and correlational analysis
Measured: Participants will be measured once
Pain intensity
Numeric Pain Rating Scale (NPRS). Outcome used primarily for description of the population and correlational analysis
Measured: Participants will be measured once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haute Ecole de Santé Vaud
- Sponsor type
- University, hospital or other
- Collaborators
- University of Brighton, University of Lausanne Hospitals
- Responsible party
- Principal investigator, Guillaume Christe, Haute Ecole de Santé Vaud
- Investigators
- Julien Favre, PhD, Study director, University of Lausanne HospitalsLucy Redhead, PhD, Study director, University of BrightonGuillaume Christe, PT, Principal investigator, Haute Ecole de Santé Vaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278549
- Sponsor's protocol ID
- MT001GC
- Status last verified
- Oct 2015
- First submitted
- 27 Oct 2014
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23823575Crosbie 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.
PubMed 24067874Dankaerts 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.
PubMed 16540876Lehman 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.
PubMed 14739876Marras 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.
PubMed 10543004Parkinson 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.
PubMed 23473753Wade 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.
PubMed 22661081
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Spinal Kinematics Between Asymptomatic Subjects and Patients With Low Back Pain Using a Multi-segment Model
- ClinicalTrials.gov ID
- NCT02278549
- Acronym / sponsor ID
- MT001GC
- Conditions
- Low Back Pain
- Keywords
- Spinal kinematics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Haute Ecole de Santé VaudUniversity, hospital or other
- Collaborators
- University of Brighton, University of Lausanne Hospitals
- Study start
- Nov 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (11 listed)
- Pregnancy
- Spondylolisthesis
- Infection
- Rheumatological or neurological diseases
- Spinal fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Score of disability
Time frame: Participants will be measured once
Score of kinesophobia
Time frame: Participants will be measured once
Score of risk of poor outcomes
Time frame: Participants will be measured once
Pain intensity
Time frame: Participants will be measured once
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2015.
- Background: PubMed 23823575Cobian 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.
- Background: PubMed 24067874Crosbie 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.
- Background: PubMed 16540876Dankaerts 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.
- Background: PubMed 14739876Lehman 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.
- Background: PubMed 10543004Marras 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.
- Background: PubMed 23473753Parkinson 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.
- Background: PubMed 22661081Wade 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien Favre, PhD study director
University of Lausanne Hospitals
Lucy Redhead, PhD study director
University of Brighton
Guillaume Christe, PT principal investigator
Haute Ecole de Santé Vaud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Haute Ecole de Santé Vaud at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal kinematics (time frame: Participants will be measured once). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02278549, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2015.