Prognostic Factors of a Favorable Outcome Following an Exercise Program for Soldiers With Low Back Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prognostic Factors of a Favorable Outcome Following a Supervised Exercise Program for Soldiers With Sub-acute and Chronic Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Multi-station full-body supervised exercise program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Other: Multi-station full-body supervised exercise program<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and 6 weeks after the start of the exercises program | 

Secondary Outcome Measures

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