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

• ClinicalTrials.gov Identifier: NCT03464877
• Recruitment Status: Completed
• First Posted: March 14, 2018
• Last Update Posted: March 15, 2018
• Sponsor: Marc Perron
• Collaborator: Canadian Forces Health Services Centre Ottawa
• Information provided by (Responsible Party): Marc Perron, Laval University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Other: Multi-station full-body supervised exercise program	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 104 participants
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective cohort study
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Prognostic Factors of a Favorable Outcome Following a Supervised Exercise Program for Soldiers With Sub-acute and Chronic Low Back Pain
• Actual Study Start Date: March 19, 2013
• Actual Primary Completion Date: March 14, 2015
• Actual Study Completion Date: April 27, 2015

Arms and Interventions

Arm

Intervention/treatment

Experimental: Intervention group; 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; 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).

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Canada, Quebec

Laval University

Quebec City, Quebec, Canada, G1V 0A6

Sponsors and Collaborators

Marc Perron

Canadian Forces Health Services Centre Ottawa

Investigators

• Principal Investigator: Marc Perron, M.Sc.; Laval University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Marc Perron, Professor of clinic, Laval University
• ClinicalTrials.gov Identifier: NCT03464877 History of Changes
• Other Study ID Numbers: 2012-13-#14
• First Posted: March 14, 2018
• Last Update Posted: March 15, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The dataset used and/or analysed during the current study is available from the corresponding author on request
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)
• Time Frame: upon publication
• Access Criteria: on request

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms