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Completed

NCT Number: NCT03464877

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laval University

Québec, Quebec, G1V 0A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-station full-body supervised exercise program

Other

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).

Primary outcomes

  1. 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

Secondary outcomes

  1. Height of participants

    Time frame: Baseline

    Tape measure graduated in meter (m)

  2. Weight of participants

    Time frame: Baseline

    On a scale graduated in kilogram (kg)

  3. Body mass index

    Time frame: Baseline

    Weight (kg) divided by the square of the height (m^2) of the participants. Units : Kg/m^2

  4. 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

  5. Length of employment in the army

    Time frame: Baseline

    Number of months - (obtained from participants interview)

  6. History of Low Back pain

    Time frame: Baseline

    Dichotomous scale (yes/No) - (obtained from participants interview)

  7. Time since last onset of low back pain

    Time frame: Baseline

    Number of months (obtained from participants interview)

  8. Number of treatments received before initial evaluation in the study

    Time frame: Baseline

    Number of visits (obtained from participants interview)

  9. Referred pain in lower limbs

    Time frame: Baseline

    Dichotomous scale (yes/No) - (obtained from participants interview)

  10. Work restrictions

    Time frame: Baseline

    Nominal scale - three levels (None, less than 6 months, six months or more) - obtained from participants interview)

  11. Sensation of tingling or numbness

    Time frame: Baseline

    Dichotomous scale (yes/No) - (obtained from participants interview)

  12. Use of antidepressant

    Time frame: Baseline

    Dichotomous scale (yes/No) - (obtained from participants interview)

  13. Use of anti-inflammatory drugs

    Time frame: Baseline

    Dichotomous scale (yes/No) - (obtained from participants interview)

  14. Pain in sitting position

    Time frame: Baseline

    Visual analog scale graduated 0-100

  15. Pain in lying position

    Time frame: Baseline

    Visual analog scale graduated 0-100

  16. Pain in standing position

    Time frame: Baseline

    Visual analog scale graduated 0-100

  17. Pain during walking

    Time frame: Baseline

    Visual analog scale graduated 0-100

  18. Pain when coughing or sneezing

    Time frame: Baseline

    Visual analog scale graduated 0-100

  19. Mean pain perceived in the last 48 hours

    Time frame: Baseline

    Visual analog scale graduated 0-10

  20. Worst pain perceived in the last 48 hours

    Time frame: Baseline

    Visual analog scale graduated 0-10

  21. Lumbar and Hip Mobility

    Time frame: Baseline

    Goniometric measurements in degree

  22. Screening or diagnostic tests of lumbar instability

    Time frame: Baseline

    Clinical tests. Dichotomous scale (+/-)

  23. Endurance of the extensor muscles of the trunk

    Time frame: Baseline

    Biering-Sorensen test. Holding time in second

  24. Endurance of the anterior abdominal muscles of the trunk

    Time frame: Baseline

    Abdominal endurance test. Holding time in second

  25. Endurance of the lateral muscles of the trunk

    Time frame: Baseline

    Lateral plank test. Holding time in second

Sponsors and collaborators

Lead sponsor

Marc Perron

Other

Collaborators

  • Canadian Forces Health Services Centre Ottawa

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 14, 2018
Registry last updated
Mar 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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