Prognostic Factors of a Favorable Outcome Following an Exercise Program for Soldiers With Low Back Pain
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ClinicalTrials.gov Identifier: NCT03464877 |
Recruitment Status :
Completed
First Posted : March 14, 2018
Last Update Posted : March 15, 2018
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Condition or disease | Intervention/treatment | Phase |
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Low Back Pain | Other: Multi-station full-body supervised exercise program | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 104 participants |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Prospective cohort study |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Prognostic Factors of a Favorable Outcome Following a Supervised Exercise Program for Soldiers With Sub-acute and Chronic Low Back Pain |
Actual Study Start Date : | March 19, 2013 |
Actual Primary Completion Date : | March 14, 2015 |
Actual Study Completion Date : | April 27, 2015 |

Arm | Intervention/treatment |
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Experimental: Intervention group
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.
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Other: Multi-station full-body supervised exercise program
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). |
- 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
- Height of participants [ Time Frame: Baseline ]Tape measure graduated in meter (m)
- Weight of participants [ Time Frame: Baseline ]On a scale graduated in kilogram (kg)
- Body mass index [ Time Frame: Baseline ]Weight (kg) divided by the square of the height (m^2) of the participants. Units : Kg/m^2
- Fear-Avoidance Beliefs Questionnaire [ Time Frame: Baseline ]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
- Length of employment in the army [ Time Frame: Baseline ]Number of months - (obtained from participants interview)
- History of Low Back pain [ Time Frame: Baseline ]Dichotomous scale (yes/No) - (obtained from participants interview)
- Time since last onset of low back pain [ Time Frame: Baseline ]Number of months (obtained from participants interview)
- Number of treatments received before initial evaluation in the study [ Time Frame: Baseline ]Number of visits (obtained from participants interview)
- Referred pain in lower limbs [ Time Frame: Baseline ]Dichotomous scale (yes/No) - (obtained from participants interview)
- Work restrictions [ Time Frame: Baseline ]Nominal scale - three levels (None, less than 6 months, six months or more) - obtained from participants interview)
- Sensation of tingling or numbness [ Time Frame: Baseline ]Dichotomous scale (yes/No) - (obtained from participants interview)
- Use of antidepressant [ Time Frame: Baseline ]Dichotomous scale (yes/No) - (obtained from participants interview)
- Use of anti-inflammatory drugs [ Time Frame: Baseline ]Dichotomous scale (yes/No) - (obtained from participants interview)
- Pain in sitting position [ Time Frame: Baseline ]Visual analog scale graduated 0-100
- Pain in lying position [ Time Frame: Baseline ]Visual analog scale graduated 0-100
- Pain in standing position [ Time Frame: Baseline ]Visual analog scale graduated 0-100
- Pain during walking [ Time Frame: Baseline ]Visual analog scale graduated 0-100
- Pain when coughing or sneezing [ Time Frame: Baseline ]Visual analog scale graduated 0-100
- Mean pain perceived in the last 48 hours [ Time Frame: Baseline ]Visual analog scale graduated 0-10
- Worst pain perceived in the last 48 hours [ Time Frame: Baseline ]Visual analog scale graduated 0-10
- Lumbar and Hip Mobility [ Time Frame: Baseline ]Goniometric measurements in degree
- Screening or diagnostic tests of lumbar instability [ Time Frame: Baseline ]Clinical tests. Dichotomous scale (+/-)
- Endurance of the extensor muscles of the trunk [ Time Frame: Baseline ]Biering-Sorensen test. Holding time in second
- Endurance of the anterior abdominal muscles of the trunk [ Time Frame: Baseline ]Abdominal endurance test. Holding time in second
- Endurance of the lateral muscles of the trunk [ Time Frame: Baseline ]Lateral plank test. Holding time in second

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- episode of subacute or chronic LBP with or without radiation to the lower limbs
- minimal score of 17% on the Modified Oswestry Disability Index
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03464877
Canada, Quebec | |
Laval University | |
Quebec City, Quebec, Canada, G1V 0A6 |
Principal Investigator: | Marc Perron, M.Sc. | Laval University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Marc Perron, Professor of clinic, Laval University |
ClinicalTrials.gov Identifier: | NCT03464877 History of Changes |
Other Study ID Numbers: |
2012-13-#14 |
First Posted: | March 14, 2018 Key Record Dates |
Last Update Posted: | March 15, 2018 |
Last Verified: | March 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | The dataset used and/or analysed during the current study is available from the corresponding author on request |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
Time Frame: | upon publication |
Access Criteria: | on request |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Back Pain Low Back Pain Pain Neurologic Manifestations Signs and Symptoms |