Low Back PainNCT03464877
Prognostic Factors of a Favorable Outcome Following an Exercise Program for Soldiers With Low Back Pain
A study testing Multi-station full-body supervised exercise program in people with Low Back Pain, run by Marc Perron at 1 site in Canada.
Trial summary
Low back pain (LBP) encompasses heterogeneous patients unlikely to respond to a unique treatment. Identifying sub-groups of low back pain may help to improve treatment outcomes. Our objective was to identify variables associated with a favorable outcome in soldiers with sub-acute and chronic LBP participating in a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Multi-station full-body supervised exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteCanada
- Study dates
- 19 Mar 2013to 27 Apr 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- episode of subacute or chronic LBP with or without radiation to the lower limbs
- minimal score of 17% on the Modified Oswestry Disability Index
Who cannot join
- previous surgery to the spinal column,
- lumber spine injection in the past two weeks
- signs of upper motor neuron lesions
- serious medical conditions (e.g. tumor, fracture, rheumatoid arthritis, osteoporosis)
- unavailability to participate in the 6-week exercise program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Factors of a Favorable Outcome Following a Supervised Exercise Program for Soldiers With Sub-acute and Chronic Low Back Pain
Low back pain (LBP) encompasses heterogeneous patients unlikely to respond to a unique treatment. Identifying sub-groups of low back pain may help to improve treatment outcomes. Our objective was to identify variables associated with a favorable outcome in soldiers with sub-acute and chronic LBP participating in a multi-station full-body supervised exercise program. The results obtained may permit generation of potential treatment effect modifiers that will eventually have to be validated before being recommended for clinical practice.
Read the detailed description
All participants took part in the 6-week exercise program, as well as in the two evaluation sessions (pre- and post- exercise program). At the initial evaluation, subjects completed forms and questionnaires on sociodemographics, symptomatology, comorbidities, work restrictions, pain and functional limitations and fear-avoidance beliefs. A physiotherapist measured their lumbar and hip mobility, conducted diagnostic and pain provocation tests and assessed endurance of the trunk muscles. Following the initial evaluation, subjects took part in the 6-week multi-station full-body supervised exercise program (2 to 3 sessions per week). The Oswestry disability questionnaire (ODI) was completed at the initial and at the final evaluations. The change in ODI score following the program was considered the principal measure reflecting favorable or unfavorable outcome.
An improvement of 50% in the initial ODI score was considered the reference standard to determine a favorable outcome. Univariate associations with favorable outcome were tested using chi-square or paired t-tests. Variables that showed between-group (favorable/unfavorable) differences were entered into a logistic regression after determining the sampling adequacy. Finally, continuous variables were dichotomized and the sensitivity, specificity and positive and negative likelihood ratios were determined for the model and for each variable.
- Conditions
- Low Back Pain
- Being tested
- Multi-station full-body supervised exercise program
- 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.
Multi-station full-body supervised exercise programOther
The exercise program was 6-week duration, 2-3 visits per week. It was composed of 7 stations, each consisting of numerous exercises of increasing difficulty. The exercises were grouped together as follows: Hip strengthening and control (Station 1); The squat and its variants (Station 2); Elastic bands and the Bodyblade (Station 3); Abdominal planks and their variants (Station 4); Abdominal strengthening (Station 5); Back extensor strengthening (Station 6); and Lifting techniques (Station 7).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Standardized six-week duration multi-station full-body supervised exercise program. The frequency was 2-3 sessions per week. The duration of each session was 60 minutes. Receives: Other: Multi-station full-body supervised exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the degree of disability in persons with Low back pain at 6 weeks
The Modified Oswestry Disability Index is a self-administered questionnaire (10 questions with numerical scale 0-5) whose purpose is to evaluate the severity of the limitations and restrictions suffered by patients with LBP
Measured: Baseline and 6 weeks after the start of the exercises program
Secondary outcomes (25)
Height of participants
Tape measure graduated in meter (m)
Measured: Baseline
Weight of participants
On a scale graduated in kilogram (kg)
Measured: Baseline
Body mass index
Weight (kg) divided by the square of the height (m^2) of the participants. Units : Kg/m^2
Measured: Baseline
Fear-Avoidance Beliefs Questionnaire
Self-administered questionnaire that consists of 16 questions (numerical scale 0-6) pertaining to patients' beliefs regarding the effect of their physical activities and work on low back pain
Measured: Baseline
Length of employment in the army
Number of months - (obtained from participants interview)
Measured: Baseline
History of Low Back pain
Dichotomous scale (yes/No) - (obtained from participants interview)
Measured: Baseline
Time since last onset of low back pain
Number of months (obtained from participants interview)
Measured: Baseline
Number of treatments received before initial evaluation in the study
Number of visits (obtained from participants interview)
Measured: Baseline
Referred pain in lower limbs
Dichotomous scale (yes/No) - (obtained from participants interview)
Measured: Baseline
Work restrictions
Nominal scale - three levels (None, less than 6 months, six months or more) - obtained from participants interview)
Measured: Baseline
Sensation of tingling or numbness
Dichotomous scale (yes/No) - (obtained from participants interview)
Measured: Baseline
Use of antidepressant
Dichotomous scale (yes/No) - (obtained from participants interview)
Measured: Baseline
Use of anti-inflammatory drugs
Dichotomous scale (yes/No) - (obtained from participants interview)
Measured: Baseline
Pain in sitting position
Visual analog scale graduated 0-100
Measured: Baseline
Pain in lying position
Visual analog scale graduated 0-100
Measured: Baseline
Pain in standing position
Visual analog scale graduated 0-100
Measured: Baseline
Pain during walking
Visual analog scale graduated 0-100
Measured: Baseline
Pain when coughing or sneezing
Visual analog scale graduated 0-100
Measured: Baseline
Mean pain perceived in the last 48 hours
Visual analog scale graduated 0-10
Measured: Baseline
Worst pain perceived in the last 48 hours
Visual analog scale graduated 0-10
Measured: Baseline
Lumbar and Hip Mobility
Goniometric measurements in degree
Measured: Baseline
Screening or diagnostic tests of lumbar instability
Clinical tests. Dichotomous scale (+/-)
Measured: Baseline
Endurance of the extensor muscles of the trunk
Biering-Sorensen test. Holding time in second
Measured: Baseline
Endurance of the anterior abdominal muscles of the trunk
Abdominal endurance test. Holding time in second
Measured: Baseline
Endurance of the lateral muscles of the trunk
Lateral plank test. Holding time in second
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start19 Mar 2013
- Primary completion14 Mar 2015
- Study completion27 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marc Perron
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Forces Health Services Centre Ottawa
- Responsible party
- Sponsor-investigator, Marc Perron, Laval University
- Investigators
- Marc Perron, M.Sc., Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464877
- Sponsor's protocol ID
- 2012-13-#14
- Status last verified
- Mar 2018
- First submitted
- 26 Feb 2018
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset used and/or analysed during the current study is available from the corresponding author on request
Publications
Perron M, Gendron C, Langevin P, Leblond J, Roos M, Roy JS. Prognostic factors of a favorable outcome following a supervised exercise program for soldiers with sub-acute and chronic low back pain. BMC Musculoskelet Disord. 2018 Apr 2;19(1):95. doi: 10.1186/s12891-018-2022-x.
PubMed 29606114
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors of a Favorable Outcome Following a Supervised Exercise Program for Soldiers With Sub-acute and Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03464877
- Acronym / sponsor ID
- 2012-13-#14
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Marc PerronUniversity, hospital or other
- Collaborators
- Canadian Forces Health Services Centre Ottawa
- Study start
- 19 Mar 2013 (actual)
- Primary completion
- 14 Mar 2015 (actual)
- Study completion
- 27 Apr 2015 (actual)
- First posted
- 14 Mar 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.
Low back pain (LBP) encompasses heterogeneous patients unlikely to respond to a unique treatment. Identifying sub-groups of low back pain may help to improve treatment outcomes. Our objective was to identify variables associated with a favorable outcome in soldiers with sub-acute and chronic LBP participating in a multi-station full-body supervised exercise program. The results obtained may permit generation of potential treatment effect modifiers that will eventually have to be validated before being recommended for clinical practice.
Detailed description
All participants took part in the 6-week exercise program, as well as in the two evaluation sessions (pre- and post- exercise program). At the initial evaluation, subjects completed forms and questionnaires on sociodemographics, symptomatology, comorbidities, work restrictions, pain and functional limitations and fear-avoidance beliefs. A physiotherapist measured their lumbar and hip mobility, conducted diagnostic and pain provocation tests and assessed endurance of the trunk muscles. Following the initial evaluation, subjects took part in the 6-week multi-station full-body supervised exercise program (2 to 3 sessions per week). The Oswestry disability questionnaire (ODI) was completed at the initial and at the final evaluations. The change in ODI score following the program was considered the principal measure reflecting favorable or unfavorable outcome.
An improvement of 50% in the initial ODI score was considered the reference standard to determine a favorable outcome. Univariate associations with favorable outcome were tested using chi-square or paired t-tests. Variables that showed between-group (favorable/unfavorable) differences were entered into a logistic regression after determining the sampling adequacy. Finally, continuous variables were dichotomized and the sensitivity, specificity and positive and negative likelihood ratios were determined for the model and for each variable.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Multi-station full-body supervised exercise programStandardized six-week duration multi-station full-body supervised exercise program. The frequency was 2-3 sessions per week. The duration of each session was 60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- episode of subacute or chronic LBP with or without radiation to the lower limbs
- minimal score of 17% on the Modified Oswestry Disability Index
Key exclusion criteria (5 listed)
- previous surgery to the spinal column,
- lumber spine injection in the past two weeks
- signs of upper motor neuron lesions
- serious medical conditions (e.g. tumor, fracture, rheumatoid arthritis, osteoporosis)
- unavailability to participate in the 6-week exercise program
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 |
|---|---|---|
| Multi-station full-body supervised exercise programThe exercise program was 6-week duration, 2-3 visits per week. It was composed of 7 stations, each consisting of numerous exercises of increasing difficulty. The exercises were grouped together as follows: Hip strengthening and control (Station 1); The squat and its variants (Station 2); Elastic bands and the Bodyblade (Station 3); Abdominal planks and their variants (Station 4); Abdominal strengthening (Station 5); Back extensor strengthening (Station 6); and Lifting techniques (Station 7). | Other | Intervention group |
Primary outcome
Change from baseline in the degree of disability in persons with Low back pain at 6 weeks
Time frame: Baseline and 6 weeks after the start of the exercises program
The Modified Oswestry Disability Index is a self-administered questionnaire (10 questions with numerical scale 0-5) whose purpose is to evaluate the severity of the limitations and restrictions suffered by patients with LBP
25 secondary outcomes
Height of participants
Time frame: Baseline
Weight of participants
Time frame: Baseline
Body mass index
Time frame: Baseline
Fear-Avoidance Beliefs Questionnaire
Time frame: Baseline
Length of employment in the army
Time frame: Baseline
History of Low Back pain
Time frame: Baseline
Time since last onset of low back pain
Time frame: Baseline
Number of treatments received before initial evaluation in the study
Time frame: Baseline
Referred pain in lower limbs
Time frame: Baseline
Work restrictions
Time frame: Baseline
Sensation of tingling or numbness
Time frame: Baseline
Use of antidepressant
Time frame: Baseline
Use of anti-inflammatory drugs
Time frame: Baseline
Pain in sitting position
Time frame: Baseline
Pain in lying position
Time frame: Baseline
Pain in standing position
Time frame: Baseline
Pain during walking
Time frame: Baseline
Pain when coughing or sneezing
Time frame: Baseline
Mean pain perceived in the last 48 hours
Time frame: Baseline
Worst pain perceived in the last 48 hours
Time frame: Baseline
Lumbar and Hip Mobility
Time frame: Baseline
Screening or diagnostic tests of lumbar instability
Time frame: Baseline
Endurance of the extensor muscles of the trunk
Time frame: Baseline
Endurance of the anterior abdominal muscles of the trunk
Time frame: Baseline
Endurance of the lateral muscles of the trunk
Time frame: Baseline
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 15 Mar 2018.
- Derived from this study: PubMed 29606114Perron M, Gendron C, Langevin P, Leblond J, Roos M, Roy JS. Prognostic factors of a favorable outcome following a supervised exercise program for soldiers with sub-acute and chronic low back pain. BMC Musculoskelet Disord. 2018 Apr 2;19(1):95. doi: 10.1186/s12891-018-2022-x.
- Individual participant dataSharing planned: Yes. The dataset used and/or analysed during the current study is available from the corresponding author on request
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Marc Perron, M.Sc. principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-station full-body supervised exercise program in people with Low Back Pain, run by Marc Perron at 1 site in Canada.
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 15 Mar 2018. 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 Canada. 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?
Change from baseline in the degree of disability in persons with Low back pain at 6 weeks (time frame: Baseline and 6 weeks after the start of the exercises program). 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 NCT03464877, which also lists 1 linked publication.
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 15 Mar 2018; AzTrials last refreshed its copy on 7 Nov 2026.