- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04334889
Measurement of Spinal Kinematics During Various Movements
Differences in Spinal Kinematics During Various Activities Between Asymptomatic Subjects and Patients With Chronic Low Back Pain
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Julien Favre, PhD
- Phone Number: 0213141868
- Email: julien.favre@chuv.ch
Study Contact Backup
- Name: Guillaume Christe, MSc
- Phone Number: 0213168123
- Email: guillaume.christe@hesav.ch
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
CLBP patients will be recruited through a multimodal rehabilitation program at Lausanne University Hospital, medical doctors or physiotherapists' consultations.
Healthy controls will be a convenience sample recruited using flyers and emails, notably posted at the Lausanne University Hospital, the University of Health Professions in Lausanne (HESAV) and at the University of Lausanne.
Description
Inclusion Criteria:
- sufficient French level to understand the instructions for the tests, the information sheet, the consent form.
For CLBP patients:
- diagnosis of non-specific low back pain (pain from lower ribs to gluteal folds) for more than 3 months.
For asymptomatic participants:
- no history of LBP requiring medical attention during the last two years
- no other concomitant pain or condition that could compromise the evaluation of lumbar kinematics.
Exclusion Criteria:
- pregnancy
- skin allergy to tape
- body mass index (BMI) above 32
For patients with CLBP only:
- specific low back pain (such as the presence of infection, rheumatological or neurological diseases, spinal fractures, tumours)
- any known important spinal deformities
- previous back surgery that limits spinal mobility
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Chronic low back pain (CLBP)
All CLBP patients should present with non-specific low back pain (pain from lower ribs to gluteal folds) for more than 3 months.
|
Participants will be asked to move following cues displayed on a screen in front of them.
|
|
Asymptomatic controls
Asymptomatic participants should have had no history of LBP requiring medical attention during the last two years and no other concomitant pain or condition that could compromise the evaluation of lumbar kinematics.
|
Participants will be asked to move following cues displayed on a screen in front of them.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spinal kinematics
Time Frame: Day 1
|
Spinal kinematics will be measured at the lumbar and thoracic spine in degrees
|
Day 1
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LBP2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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