Chronic Low Back PainNCT03499613
Spinal Kinematics in Chronic Low Back Pain
An observational study of Chronic Low Back Pain, run by Haute Ecole de Santé Vaud at 1 site in Switzerland.
Trial summary
Chronic low back pain (CLBP) is one of the most frequent causes for limitations in daily, leisure and work-related activities. Although alterations in spinal motor behavior were consistently reported in CLBP patients, it remains unclear how improvements in spinal motor behavior through rehabilitation treatment affect… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Multidisciplinary rehabilitation program
- How many people
- 71 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Apr 2018to 30 Oct 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic low back pain for more than three months participating to a 3 weeks' multidisciplinary rehabilitation program
Who may be able to join
- non-specific low back pain (pain from lower ribs to gluteal folds) for more than 3 months
- sufficient French level to understand the instructions for the tests, the information sheet, the consent form and the questionnaires
- both male and female adults will be included
- age more than 18 years old.
Who cannot join
- pregnancy
- skin allergy to tape
- body mass index (BMI) above 32
- any sign of specific low back pain such as the presence of infection, rheumatologic 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 in Chronic Low Back Pain: a Cohort Study
Chronic low back pain (CLBP) is one of the most frequent causes for limitations in daily, leisure and work-related activities. Although alterations in spinal motor behavior were consistently reported in CLBP patients, it remains unclear how improvements in spinal motor behavior through rehabilitation treatment affect pain and disability. Psychological factors, such as pain-related fear, were suggested as a possible main cause of spinal motor behavior in CLBP and better understanding their relationships with kinematic and muscle activity alterations is required to enhance care, particularly physiotherapy. Therefore, this study will test CLBP patients before and after a 3 week rehabilitation program to test the hypotheses that: 1) improvements in spinal motor behavior (kinematics and trunk muscle activity) are associated with decreased pain and disability; 2) decrease in pain-related fear is associated with spinal motor behavior improvements.
Read the detailed description
The research project is a prospective observational cohort study. CLBP patients participating to a 3 weeks' multimodal rehabilitation program will be tested in the motion analysis laboratory before (T1) and after (T2) the program. This program is an intensive 3-weeks multidisciplinary rehabilitation program. Patients come daily for individual and group treatments, with a total of 100 hours of intervention during 3 weeks. The program includes physiotherapy treatments, occupational therapy, psychologists encounters and education session. The programs encompasses a multidimensional view of chronic low back pain. Therefore, this setting is a unique opportunity to improve our understanding of the role of motor behavior alterations in CLBP because it will allow connecting changes in spinal kinematics and muscle activity with changes in pain, disability and pain-related fear.
This project has two aims in relation to motor behavior in patients with CLBP:
The first aim is to analyse the relationship between changes in spinal kinematics and changes in pain and disability during and after a multimodal rehabilitation program. First, changes in spinal kinematics and muscle activity between T1 and T2 will be calculated. The relationship between these changes and changes in pain and disability during the program will be tested. Pain and disability will be also measured at 3 months (T3) and one year (T4) after the program, which will allow to further analyze the relationship between spinal motor behavior and pain and disability.
The second aim concerns the role of pain-related fear, and its decrease, in spinal motor behavior alterations. Consequently, the second aim is to analyse if changes in pain-related fear are associated with changes in spinal kinematics during a multimodal rehabilitation program.
- Conditions
- Chronic Low Back Pain
- Being tested
- Multidisciplinary rehabilitation program
- Keywords
- Movement analysis, Spinal kinematics, Muscle activity, Pain-related fear, Rehabilitation, Spine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary rehabilitation programOther
The multimodal rehabilitation program (MRP) based at the University Hospital is an intensive 3-weeks multidisciplinary rehabilitation program. Patients come daily for individual and group treatments, with a total of 100 hours of intervention during 3 weeks. The MRP includes physiotherapy treatments, aiming at improving cardio-vascular endurance, long-term physical activity adherence, proprioception, mobility and strength. Additionally, occupational therapy is mainly focussed on reassuring patients that spinal movements are safe. Finally, psychologists are involved in the MRP to discuss the meaning of LBP, the psychological implications and the patient's resources.
| Study group | Role | What they receive |
|---|---|---|
| Chronic low back pain | Patients with chronic low back pain participating to a 3 weeks Multidisciplinary rehabilitation program Receives: Other: Multidisciplinary rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal kinematics
Range of movement and angular velocity at the lower lumbar, upper lumbar, lower thoracic and upper thoracic joints
Measured: Change between baseline and week 4
Trunk muscle activity
Surface electromyography of paraspinal and abdominal muscles
Measured: Change between baseline and week 4
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: Change between baseline and week 4
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: Change between baseline and week 4
Kinesiophobia
Tampa Scale of Kinesiophobia. The total score is between 17 (no kinesiophobia) to 68 (high level of kinesiophobia).
Measured: Change between baseline and week 4
Pain-related fear
Photograph Series of Daily Activities. The score is from 0 (no pain-related fear) to 100 (high levels of pain related fear)
Measured: Change between baseline and week 4
Fear
Fear scale measured before each movement or activity. Score between 0 (no fear) and 10 (high levels of fear).
Measured: Change between baseline and week 4
Pain expectation
Pain expectation scale before each movement or activity. Score between 0 (no pain expected) and 10 (high levels of pain expected).
Measured: Change between baseline and week 4
Secondary outcomes (10)
Disability (ODI)
Oswestry Disability Questionnaire. Score between 0 (no disability) and 100.
Measured: Baseline (Day 0), week 4, Month 3, Month 12
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: Month 3, Month 12
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: Month 3, Month 12
Catastrophizing
Pain Catastrophizing Scale. Score between 0 and 52 (high levels of catastrophizing).
Measured: Baseline (Day 0), week 4, Month 3, Month 12
Back Pain Attitudes
Back Pain Attitudes Questionnaires. Score between 34 (positive attitudes and beliefs) and 170 (negative attitudes and beliefs)
Measured: Baseline (Day 0), week 4, Month 3, Month 12
Kinesiophobia
Tampa Scale of Kinesiophobia. The total score is between 17 (no kinesiophobia) to 68 (high level of kinesiophobia).
Measured: Month 3, Month 12
Level of Bothersomeness
Bothersomeness mesaured with a scale with one question scored from 0 to 4 (Dunn et al, Spine, 2005).
Measured: Baseline (Day 0), week 4, Month 3, Month 12
Level of Worry about back pain
Worry numeric scale. Worry about current back pain is scored from 0 (no worry) to 10 (extremely worried).
Measured: Baseline (Day 0), week 4, Month 3, Month 12
Work ability
Work ability. Is back pain limiting the ability to work normally (answer: Yes or No)?
Measured: Baseline (Day 0), Month 3, Month 12
Patient Global Impression of Change
This measure is a single-item rating by participants of their improvement with treatment on a 7-point scale that ranges from 'very much improved' (3 points) to 'very much worse' (-3 points) with 'no change' as the mid-point (0 points). The patient will answer this question: "With respect to your low back pain how would you describe yourself now, compared to before the start of the rehabilitation program you did at the University Hospital?"
Measured: Month 3, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start13 Apr 2018
- Primary completion30 Oct 2020
- Study completion30 Oct 2021
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haute Ecole de Santé Vaud
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals, University of Lausanne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499613
- Sponsor's protocol ID
- LBPKINCOH2017
- Status last verified
- Jan 2022
- First submitted
- 14 Mar 2018
- Last updated
- 11 Jan 2022
- 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 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Kinematics in Chronic Low Back Pain: a Cohort Study
- ClinicalTrials.gov ID
- NCT03499613
- Acronym / sponsor ID
- LBPKINCOH2017
- Conditions
- Chronic Low Back Pain
- Keywords
- Movement analysis, Spinal kinematics, Muscle activity, Pain-related fear, Rehabilitation, Spine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Haute Ecole de Santé VaudUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals, University of Lausanne
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 17 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.
Chronic low back pain (CLBP) is one of the most frequent causes for limitations in daily, leisure and work-related activities. Although alterations in spinal motor behavior were consistently reported in CLBP patients, it remains unclear how improvements in spinal motor behavior through rehabilitation treatment affect pain and disability. Psychological factors, such as pain-related fear, were suggested as a possible main cause of spinal motor behavior in CLBP and better understanding their relationships with kinematic and muscle activity alterations is required to enhance care, particularly physiotherapy. Therefore, this study will test CLBP patients before and after a 3 week rehabilitation program to test the hypotheses that: 1) improvements in spinal motor behavior (kinematics and trunk muscle activity) are associated with decreased pain and disability; 2) decrease in pain-related fear is associated with spinal motor behavior improvements.
Detailed description
The research project is a prospective observational cohort study. CLBP patients participating to a 3 weeks' multimodal rehabilitation program will be tested in the motion analysis laboratory before (T1) and after (T2) the program. This program is an intensive 3-weeks multidisciplinary rehabilitation program. Patients come daily for individual and group treatments, with a total of 100 hours of intervention during 3 weeks. The program includes physiotherapy treatments, occupational therapy, psychologists encounters and education session. The programs encompasses a multidimensional view of chronic low back pain. Therefore, this setting is a unique opportunity to improve our understanding of the role of motor behavior alterations in CLBP because it will allow connecting changes in spinal kinematics and muscle activity with changes in pain, disability and pain-related fear.
This project has two aims in relation to motor behavior in patients with CLBP:
The first aim is to analyse the relationship between changes in spinal kinematics and changes in pain and disability during and after a multimodal rehabilitation program. First, changes in spinal kinematics and muscle activity between T1 and T2 will be calculated. The relationship between these changes and changes in pain and disability during the program will be tested. Pain and disability will be also measured at 3 months (T3) and one year (T4) after the program, which will allow to further analyze the relationship between spinal motor behavior and pain and disability.
The second aim concerns the role of pain-related fear, and its decrease, in spinal motor behavior alterations. Consequently, the second aim is to analyse if changes in pain-related fear are associated with changes in spinal kinematics during a multimodal rehabilitation program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic low back pain | – | Other: Multidisciplinary rehabilitation programPatients with chronic low back pain participating to a 3 weeks Multidisciplinary rehabilitation program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic low back pain for more than three months participating to a 3 weeks' multidisciplinary rehabilitation program
Key inclusion criteria (4 listed)
- non-specific low back pain (pain from lower ribs to gluteal folds) for more than 3 months
- sufficient French level to understand the instructions for the tests, the information sheet, the consent form and the questionnaires
- both male and female adults will be included
- age more than 18 years old.
Key exclusion criteria (6 listed)
- pregnancy
- skin allergy to tape
- body mass index (BMI) above 32
- any sign of specific low back pain such as the presence of infection, rheumatologic 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary rehabilitation programThe multimodal rehabilitation program (MRP) based at the University Hospital is an intensive 3-weeks multidisciplinary rehabilitation program. Patients come daily for individual and group treatments, with a total of 100 hours of intervention during 3 weeks. The MRP includes physiotherapy treatments, aiming at improving cardio-vascular endurance, long-term physical activity adherence, proprioception, mobility and strength. Additionally, occupational therapy is mainly focussed on reassuring patients that spinal movements are safe. Finally, psychologists are involved in the MRP to discuss the meaning of LBP, the psychological implications and the patient's resources. | Other | Chronic low back pain |
Primary outcome
Spinal kinematics
Time frame: Change between baseline and week 4
Range of movement and angular velocity at the lower lumbar, upper lumbar, lower thoracic and upper thoracic joints
Trunk muscle activity
Time frame: Change between baseline and week 4
Surface electromyography of paraspinal and abdominal muscles
Pain intensity
Time frame: Change between baseline and week 4
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).
Disability
Time frame: Change between baseline and week 4
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).
Kinesiophobia
Time frame: Change between baseline and week 4
Tampa Scale of Kinesiophobia. The total score is between 17 (no kinesiophobia) to 68 (high level of kinesiophobia).
Pain-related fear
Time frame: Change between baseline and week 4
Photograph Series of Daily Activities. The score is from 0 (no pain-related fear) to 100 (high levels of pain related fear)
Fear
Time frame: Change between baseline and week 4
Fear scale measured before each movement or activity. Score between 0 (no fear) and 10 (high levels of fear).
Pain expectation
Time frame: Change between baseline and week 4
Pain expectation scale before each movement or activity. Score between 0 (no pain expected) and 10 (high levels of pain expected).
10 secondary outcomes
Disability (ODI)
Time frame: Baseline (Day 0), week 4, Month 3, Month 12
Disability
Time frame: Month 3, Month 12
Pain intensity
Time frame: Month 3, Month 12
Catastrophizing
Time frame: Baseline (Day 0), week 4, Month 3, Month 12
Back Pain Attitudes
Time frame: Baseline (Day 0), week 4, Month 3, Month 12
Kinesiophobia
Time frame: Month 3, Month 12
Level of Bothersomeness
Time frame: Baseline (Day 0), week 4, Month 3, Month 12
Level of Worry about back pain
Time frame: Baseline (Day 0), week 4, Month 3, Month 12
Work ability
Time frame: Baseline (Day 0), Month 3, Month 12
Patient Global Impression of Change
Time frame: Month 3, Month 12
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 Jan 2022.
- 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 4 inclusion and 6 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 Jan 2022. 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 baseline and week 4). The study lists 8 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 NCT03499613, 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 Jan 2022.