Clinical trial NCT03464877: Prognostic Factors of a Favorable Outcome Following an Exercise Program for Soldiers With Low Back Pain
Official title: Prognostic Factors of a Favorable Outcome Following a Supervised Exercise Program for Soldiers With Sub-acute and Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Canadian Forces Health Services Centre Ottawa
First posted: 2018-03-14
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the degree of disability in persons with Low back pain at 6 weeks
timeFrame: Baseline and 6 weeks after the start of the exercises program
Secondary outcomes:
measure: Height of participants
timeFrame: Baseline
measure: Weight of participants
timeFrame: Baseline
measure: Body mass index
timeFrame: Baseline
measure: Fear-Avoidance Beliefs Questionnaire
timeFrame: Baseline
measure: Length of employment in the army
timeFrame: Baseline
measure: History of Low Back pain
timeFrame: Baseline
measure: Time since last onset of low back pain
timeFrame: Baseline
measure: Number of treatments received before initial evaluation in the study
timeFrame: Baseline
measure: Referred pain in lower limbs
timeFrame: Baseline
measure: Work restrictions
timeFrame: Baseline
measure: Sensation of tingling or numbness
timeFrame: Baseline
measure: Use of antidepressant
timeFrame: Baseline
measure: Use of anti-inflammatory drugs
timeFrame: Baseline
measure: Pain in sitting position
timeFrame: Baseline
measure: Pain in lying position
timeFrame: Baseline
measure: Pain in standing position
timeFrame: Baseline
measure: Pain during walking
timeFrame: Baseline
measure: Pain when coughing or sneezing
timeFrame: Baseline
measure: Mean pain perceived in the last 48 hours
timeFrame: Baseline
measure: Worst pain perceived in the last 48 hours
timeFrame: Baseline
measure: Lumbar and Hip Mobility
timeFrame: Baseline
measure: Screening or diagnostic tests of lumbar instability
timeFrame: Baseline
measure: Endurance of the extensor muscles of the trunk
timeFrame: Baseline
measure: Endurance of the anterior abdominal muscles of the trunk
timeFrame: Baseline
measure: Endurance of the lateral muscles of the trunk
timeFrame: Baseline
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Laval University
state: Quebec
Study officials:
affiliation: Laval University
name: Marc Perron, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.