Prognostic Factors of a Favorable Outcome Following an Exercise Program for Soldiers With Low Back Pain
- Conditions
- Low Back Pain
- Interventions
- Other: Multi-station full-body supervised exercise program
- Registration Number
- NCT03464877
- Lead Sponsor
- Marc Perron
- Brief 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- episode of subacute or chronic LBP with or without radiation to the lower limbs
- minimal score of 17% on the Modified Oswestry Disability Index
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention group Multi-station full-body supervised exercise program 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.
- Primary Outcome Measures
Name Time Method Change from baseline in the degree of disability in persons with Low back pain at 6 weeks 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
- Secondary Outcome Measures
Name Time Method Lumbar and Hip Mobility Baseline Goniometric measurements in degree
Screening or diagnostic tests of lumbar instability Baseline Clinical tests. Dichotomous scale (+/-)
Endurance of the extensor muscles of the trunk Baseline Biering-Sorensen test. Holding time in second
Endurance of the anterior abdominal muscles of the trunk Baseline Abdominal endurance test. Holding time in second
Endurance of the lateral muscles of the trunk Baseline Lateral plank test. Holding time in second
Length of employment in the army Baseline Number of months - (obtained from participants interview)
Height of participants Baseline Tape measure graduated in meter (m)
Fear-Avoidance Beliefs Questionnaire 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
History of Low Back pain Baseline Dichotomous scale (yes/No) - (obtained from participants interview)
Weight of participants Baseline On a scale graduated in kilogram (kg)
Body mass index Baseline Weight (kg) divided by the square of the height (m\^2) of the participants. Units : Kg/m\^2
Time since last onset of low back pain Baseline Number of months (obtained from participants interview)
Number of treatments received before initial evaluation in the study Baseline Number of visits (obtained from participants interview)
Referred pain in lower limbs Baseline Dichotomous scale (yes/No) - (obtained from participants interview)
Work restrictions Baseline Nominal scale - three levels (None, less than 6 months, six months or more) - obtained from participants interview)
Sensation of tingling or numbness Baseline Dichotomous scale (yes/No) - (obtained from participants interview)
Use of antidepressant Baseline Dichotomous scale (yes/No) - (obtained from participants interview)
Use of anti-inflammatory drugs Baseline Dichotomous scale (yes/No) - (obtained from participants interview)
Pain in sitting position Baseline Visual analog scale graduated 0-100
Pain in lying position Baseline Visual analog scale graduated 0-100
Pain in standing position Baseline Visual analog scale graduated 0-100
Pain during walking Baseline Visual analog scale graduated 0-100
Pain when coughing or sneezing Baseline Visual analog scale graduated 0-100
Mean pain perceived in the last 48 hours Baseline Visual analog scale graduated 0-10
Worst pain perceived in the last 48 hours Baseline Visual analog scale graduated 0-10
Trial Locations
- Locations (1)
Laval University
🇨🇦Quebec City, Quebec, Canada