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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03464877
Enrollment
104
Registered
2018-03-14
Start date
2013-03-19
Completion date
2015-04-27
Last updated
2018-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

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.

Interventions

OTHERMulti-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).

Sponsors

Canadian Forces Health Services Centre Ottawa
CollaboratorOTHER
Marc Perron
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Prospective cohort study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in the degree of disability in persons with Low back pain at 6 weeksBaseline and 6 weeks after the start of the exercises programThe 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

MeasureTime frameDescription
Weight of participantsBaselineOn a scale graduated in kilogram (kg)
Body mass indexBaselineWeight (kg) divided by the square of the height (m\^2) of the participants. Units : Kg/m\^2
Fear-Avoidance Beliefs QuestionnaireBaselineSelf-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 armyBaselineNumber of months - (obtained from participants interview)
History of Low Back painBaselineDichotomous scale (yes/No) - (obtained from participants interview)
Time since last onset of low back painBaselineNumber of months (obtained from participants interview)
Number of treatments received before initial evaluation in the studyBaselineNumber of visits (obtained from participants interview)
Referred pain in lower limbsBaselineDichotomous scale (yes/No) - (obtained from participants interview)
Work restrictionsBaselineNominal scale - three levels (None, less than 6 months, six months or more) - obtained from participants interview)
Sensation of tingling or numbnessBaselineDichotomous scale (yes/No) - (obtained from participants interview)
Use of antidepressantBaselineDichotomous scale (yes/No) - (obtained from participants interview)
Use of anti-inflammatory drugsBaselineDichotomous scale (yes/No) - (obtained from participants interview)
Height of participantsBaselineTape measure graduated in meter (m)
Pain in lying positionBaselineVisual analog scale graduated 0-100
Pain in standing positionBaselineVisual analog scale graduated 0-100
Pain during walkingBaselineVisual analog scale graduated 0-100
Pain when coughing or sneezingBaselineVisual analog scale graduated 0-100
Mean pain perceived in the last 48 hoursBaselineVisual analog scale graduated 0-10
Worst pain perceived in the last 48 hoursBaselineVisual analog scale graduated 0-10
Lumbar and Hip MobilityBaselineGoniometric measurements in degree
Screening or diagnostic tests of lumbar instabilityBaselineClinical tests. Dichotomous scale (+/-)
Endurance of the extensor muscles of the trunkBaselineBiering-Sorensen test. Holding time in second
Endurance of the anterior abdominal muscles of the trunkBaselineAbdominal endurance test. Holding time in second
Endurance of the lateral muscles of the trunkBaselineLateral plank test. Holding time in second
Pain in sitting positionBaselineVisual analog scale graduated 0-100

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026