Chronic Low Back PainNCT03507296
Spinal Kinematics Variability
An observational study of Chronic Low Back Pain, run by Haute Ecole de Santé Vaud at 1 site in Switzerland.
Trial summary
This study will test the within and between day variability of spinal kinematics and trunk muscle activity in healthy subjects and chronic low back pain patients during various daily-life activities. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Apr 2018to 25 Sep 2020
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chronic low back pain patients
Who may be able to join
- sufficient French level to understand the instructions for the tests, the information sheet, the consent form and the questionnaires
- All chronic low back pain patients should present with non-specific low back pain (pain from lower ribs to gluteal folds) for more than 3 months.
Who cannot join
- pregnancy
- body mass index (BMI) that is above 32
- patients should not have any sign of specific low back pain such as the presence of infection, rheumatological or neurological diseases, spinal fractures, any known important spinal deformities, previous back surgery that limits spinal mobility, tumours
- 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.
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: Spinal Kinematics Variability in Healthy Subjects and Patients With Chronic Low Back Pain in Different Functional Activities
This study will test the within and between day variability of spinal kinematics and trunk muscle activity in healthy subjects and chronic low back pain patients during various daily-life activities.
Read the detailed description
This study will test the within and between day variability of spinal kinematics and trunk muscle activity in healthy subjects and chronic low back pain patients during various daily-life activities. Participants will come twice to the motion laboratory. During the first session, participants will first perform different functional activities (V1), such as sit-to-stand, gait, lifting tasks, stepping up. Their spinal kinematics will be measured with a camera-based system (VICON) using a multi-segment spinal model and trunk muscles activity will be recorded with surface electromyography. After a break, participants will have to perform all the functional activities a second time (V2). These two measures (V1 and V2) will be used to determine the within day variability of spinal kinematics. Finally, all participants will come one week later (V3) to repeat all the measurements to determine the between day variability.
- Conditions
- Chronic 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 |
|---|---|---|
| Chronic low back pain patients | Not described | |
| Asymptomatic subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal kinematics
Range of movement at the lower lumbar, upper lumbar, lower thoracic and upper thoracic joints
Measured: Change between measure 1 and measure 2 (30 minutes later)
Trunk muscle activity
Surface electromyography of paraspinal, rectus abdominis and external obliques muscles
Measured: Change between measure 1 and measure 2 (30 minutes later)
Spinal kinematics
Range of movement at the lower lumbar, upper lumbar, lower thoracic and upper thoracic joints
Measured: Change between measure 1 and measure 3 (day 7)
Trunk muscle activity
Surface electromyography of paraspinal, rectus abdominis and external obliques muscles
Measured: Change between measure 1 and measure 3 (day 7)
Secondary outcomes (8)
Pain intensity
Pain intensity will be quantified by the 11-point Numeric Pain Rating Scale. The scale range from 0 (no pain at all) to 10 (worst pain).
Measured: Measure 1 (Day 0), Measure 3 (Day 7)
Disability
Disability will be quantified by the Patient Specific Functional Scale. The scale assessed three relevant activities for the patient and scores each activity between 0 (impossible to realize the activity) to 10 (capable of doing the activity normally).
Measured: Measure 1 (Day 0), Measure 3 (Day 7)
Disability (ODI)
Oswestry Disability Questionnaire. Score between 0 (no disability) and 100.
Measured: Measure 1 (Day 0), Measure 3 (Day 7).
Kinesiophobia
Tampa Scale of Kinesiophobia. The total score is between 17 (no kinesiophobia) to 68 (high level of kinesiophobia).
Measured: Measure 1 (Day 0), Measure 3 (Day 7).
Catastrophizing
Pain Catastrophizing Scale. Score between 0 and 52 (high levels of catastrophizing).
Measured: Measure 1 (Day 0), Measure 3 (Day 7).
Back Pain Attitudes Questionnaire
Back Pain Attitudes Questionnaire. Score between 34 (positive attitudes) and 170 (negative attitudes)
Measured: Measure 1 (Day 0), Measure 3 (Day 7).
Fear
Fear scale measured before each movement or activity. Score between 0 (no fear) and 10 (high levels of fear).
Measured: Measure 1 (Day 0), Measure 2 (Day 0), Measure 3 (Day 7).
Pain expectation
Pain expectation scale before each movement or activity. Score between 0 (no pain expected) and 10 (high levels of pain expected).
Measured: Measure 1 (Day 0), Measure 2 (Day 0), Measure 3 (Day 7).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start13 Apr 2018
- Primary completion25 Sep 2020
- Study completion25 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haute Ecole de Santé Vaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507296
- Sponsor's protocol ID
- VAR2017
- Status last verified
- Oct 2021
- First submitted
- 14 Mar 2018
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Christe G, Redhead L, Legrand T, Jolles BM, Favre J. Multi-segment analysis of spinal kinematics during sit-to-stand in patients with chronic low back pain. J Biomech. 2016 Jul 5;49(10):2060-2067. doi: 10.1016/j.jbiomech.2016.05.015. Epub 2016 May 20.
PubMed 27262182Christe G, Kade F, Jolles BM, Favre J. Chronic low back pain patients walk with locally altered spinal kinematics. J Biomech. 2017 Jul 26;60:211-218. doi: 10.1016/j.jbiomech.2017.06.042. Epub 2017 Jul 5.
PubMed 28716466
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Kinematics Variability in Healthy Subjects and Patients With Chronic Low Back Pain in Different Functional Activities
- ClinicalTrials.gov ID
- NCT03507296
- Acronym / sponsor ID
- VAR2017
- Conditions
- Chronic Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Haute Ecole de Santé VaudUniversity, hospital or other
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 25 Sep 2020 (actual)
- First posted
- 25 Apr 2018 (actual)
- 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.
This study will test the within and between day variability of spinal kinematics and trunk muscle activity in healthy subjects and chronic low back pain patients during various daily-life activities.
Detailed description
This study will test the within and between day variability of spinal kinematics and trunk muscle activity in healthy subjects and chronic low back pain patients during various daily-life activities. Participants will come twice to the motion laboratory. During the first session, participants will first perform different functional activities (V1), such as sit-to-stand, gait, lifting tasks, stepping up. Their spinal kinematics will be measured with a camera-based system (VICON) using a multi-segment spinal model and trunk muscles activity will be recorded with surface electromyography. After a break, participants will have to perform all the functional activities a second time (V2). These two measures (V1 and V2) will be used to determine the within day variability of spinal kinematics. Finally, all participants will come one week later (V3) to repeat all the measurements to determine the between day variability.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic low back pain patients | – | – |
| Asymptomatic subjects | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic low back pain patients
Key inclusion criteria (2 listed)
- sufficient French level to understand the instructions for the tests, the information sheet, the consent form and the questionnaires
- All chronic low back pain patients should present with non-specific low back pain (pain from lower ribs to gluteal folds) for more than 3 months.
Key exclusion criteria (5 listed)
- pregnancy
- body mass index (BMI) that is above 32
- patients should not have any sign of specific low back pain such as the presence of infection, rheumatological or neurological diseases, spinal fractures, any known important spinal deformities, previous back surgery that limits spinal mobility, tumours
- 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.
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: Change between measure 1 and measure 2 (30 minutes later)
Range of movement at the lower lumbar, upper lumbar, lower thoracic and upper thoracic joints
Trunk muscle activity
Time frame: Change between measure 1 and measure 2 (30 minutes later)
Surface electromyography of paraspinal, rectus abdominis and external obliques muscles
Spinal kinematics
Time frame: Change between measure 1 and measure 3 (day 7)
Range of movement at the lower lumbar, upper lumbar, lower thoracic and upper thoracic joints
Trunk muscle activity
Time frame: Change between measure 1 and measure 3 (day 7)
Surface electromyography of paraspinal, rectus abdominis and external obliques muscles
8 secondary outcomes
Pain intensity
Time frame: Measure 1 (Day 0), Measure 3 (Day 7)
Disability
Time frame: Measure 1 (Day 0), Measure 3 (Day 7)
Disability (ODI)
Time frame: Measure 1 (Day 0), Measure 3 (Day 7).
Kinesiophobia
Time frame: Measure 1 (Day 0), Measure 3 (Day 7).
Catastrophizing
Time frame: Measure 1 (Day 0), Measure 3 (Day 7).
Back Pain Attitudes Questionnaire
Time frame: Measure 1 (Day 0), Measure 3 (Day 7).
Fear
Time frame: Measure 1 (Day 0), Measure 2 (Day 0), Measure 3 (Day 7).
Pain expectation
Time frame: Measure 1 (Day 0), Measure 2 (Day 0), Measure 3 (Day 7).
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 11 Oct 2021.
- Background: PubMed 27262182Christe G, Redhead L, Legrand T, Jolles BM, Favre J. Multi-segment analysis of spinal kinematics during sit-to-stand in patients with chronic low back pain. J Biomech. 2016 Jul 5;49(10):2060-2067. doi: 10.1016/j.jbiomech.2016.05.015. Epub 2016 May 20.
- Background: PubMed 28716466Christe G, Kade F, Jolles BM, Favre J. Chronic low back pain patients walk with locally altered spinal kinematics. J Biomech. 2017 Jul 26;60:211-218. doi: 10.1016/j.jbiomech.2017.06.042. Epub 2017 Jul 5.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic 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 2 inclusion and 5 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 11 Oct 2021. 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: Change between measure 1 and measure 2 (30 minutes later)). The study lists 4 primary outcomes in all. 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 NCT03507296, which also lists 2 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 11 Oct 2021.