Non-specific Low Back PainMARLONCT03097263
Is the Walking Velocity an Efficient Outcome of Rehabilitation Program in Non- Specific Low Back Pain Patient
An observational study of Non-specific Low Back Pain and Functional Capacities, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Despite the prevalence of chronic low back pain, functional symptomatology of this disease remains poor and treatment decisions are based mainly on subjective data (importance and pain tolerance). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-specific Low Back Pain, Functional Capacities
- What is being tested?
- Physical Rehabilitation program
- How many people
- 127 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Nov 2016
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Non-specific low back pain patients included for rehabilitation program
Who may be able to join
- Female or male
- age between 18 and 70
- Non-specific low back pain - achieved rehabilitation program
Who cannot join
- inflammatory diseases
- cancer
- infectious diseases
Trial locations and contacts
1 site in 1 country.
About this study
Despite the prevalence of chronic low back pain, functional symptomatology of this disease remains poor and treatment decisions are based mainly on subjective data (importance and pain tolerance). However, there are some experimental elements that involve objective assessment of locomotor capabilities - at forefront objectives which the walking velocity in the evaluation of this pathology in terms of severity of functional impairment. Recent evidence suggest the effectiveness of physical rehabilitation program for improving patients functional capacities and their reintegration in socio-professional life. This retrospective study aims to quantify the evolution of the parameters collected during standardized walking tests performed before and after rehabilitation program. These patients have systematically carry out a comfortable walk test (400m walk test) and a brisk walk test (200m) at the beginning and end of their program. Furthermore, a maximal stress test on a treadmill was performed before the program in order to detect any cardiovascular events and to allow the personalization of the effort level required (target heart rate) during rehabilitation. In this study the evolution of the comfortable and fast speed will be collected and compared with the stress test data, and other measured parameters (functional score of Quebec, muscle Tests Shirado and Sorensen).
- Conditions
- Non-specific Low Back Pain, Functional Capacities
- Being tested
- Physical Rehabilitation program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Rehabilitation programOther
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients included for rehabilitation program Receives: Other: Physical Rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
COMFORTABLE WALKING SPEED (TEST OF 400M)
Measured: 4 weeks
Secondary outcomes (4)
200m fast walk test walking velocity
Measured: 4 weeks
Quebec score
Measured: 4 weeks
Shirado test
Measured: 4 weeks
Sorensen test
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study startJan 2014
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific Low Back PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097263
- Sponsor's protocol ID
- CASILLAS Marlo 2016
- Acronym
- MARLO
- Status last verified
- Mar 2017
- First submitted
- 3 Nov 2016
- Last updated
- 31 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Walking Velocity an Efficient Outcome of Rehabilitation Program in Non- Specific Low Back Pain Patient
- ClinicalTrials.gov ID
- NCT03097263
- Acronym / sponsor ID
- MARLO / CASILLAS Marlo 2016
- Conditions
- Non-specific Low Back Pain, Functional Capacities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 31 Mar 2017 (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.
Despite the prevalence of chronic low back pain, functional symptomatology of this disease remains poor and treatment decisions are based mainly on subjective data (importance and pain tolerance). However, there are some experimental elements that involve objective assessment of locomotor capabilities - at forefront objectives which the walking velocity in the evaluation of this pathology in terms of severity of functional impairment. Recent evidence suggest the effectiveness of physical rehabilitation program for improving patients functional capacities and their reintegration in socio-professional life. This retrospective study aims to quantify the evolution of the parameters collected during standardized walking tests performed before and after rehabilitation program. These patients have systematically carry out a comfortable walk test (400m walk test) and a brisk walk test (200m) at the beginning and end of their program. Furthermore, a maximal stress test on a treadmill was performed before the program in order to detect any cardiovascular events and to allow the personalization of the effort level required (target heart rate) during rehabilitation. In this study the evolution of the comfortable and fast speed will be collected and compared with the stress test data, and other measured parameters (functional score of Quebec, muscle Tests Shirado and Sorensen).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Physical Rehabilitation programPatients included for rehabilitation program |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-specific low back pain patients included for rehabilitation program
Key inclusion criteria (3 listed)
- Female or male
- age between 18 and 70
- Non-specific low back pain - achieved rehabilitation program
Key exclusion criteria (3 listed)
- inflammatory diseases
- cancer
- infectious diseases
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 |
|---|---|---|
| Physical Rehabilitation program | Other | Patients |
Primary outcome
COMFORTABLE WALKING SPEED (TEST OF 400M)
Time frame: 4 weeks
4 secondary outcomes
200m fast walk test walking velocity
Time frame: 4 weeks
Quebec score
Time frame: 4 weeks
Shirado test
Time frame: 4 weeks
Sorensen test
Time frame: 4 weeks
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 31 Mar 2017.
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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 Non-specific Low Back Pain and Functional Capacities, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 3 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 31 Mar 2017. 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 France. 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?
COMFORTABLE WALKING SPEED (TEST OF 400M) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2017.