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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Multi-station full-body supervised exercise program

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Quebec City, Quebec, Canada, G1V 0A6
      • Laval University

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the degree of disability in persons with Low back pain at 6 weeks	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	Baseline and 6 weeks after the start of the exercises program

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height of participants	Tape measure graduated in meter (m)	Baseline
Weight of participants	On a scale graduated in kilogram (kg)	Baseline
Body mass index	Weight (kg) divided by the square of the height (m^2) of the participants. Units : Kg/m^2	Baseline
Fear-Avoidance Beliefs Questionnaire	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	Baseline
Length of employment in the army	Number of months - (obtained from participants interview)	Baseline
History of Low Back pain	Dichotomous scale (yes/No) - (obtained from participants interview)	Baseline
Time since last onset of low back pain	Number of months (obtained from participants interview)	Baseline
Number of treatments received before initial evaluation in the study	Number of visits (obtained from participants interview)	Baseline
Referred pain in lower limbs	Dichotomous scale (yes/No) - (obtained from participants interview)	Baseline
Work restrictions	Nominal scale - three levels (None, less than 6 months, six months or more) - obtained from participants interview)	Baseline
Sensation of tingling or numbness	Dichotomous scale (yes/No) - (obtained from participants interview)	Baseline
Use of antidepressant	Dichotomous scale (yes/No) - (obtained from participants interview)	Baseline
Use of anti-inflammatory drugs	Dichotomous scale (yes/No) - (obtained from participants interview)	Baseline
Pain in sitting position	Visual analog scale graduated 0-100	Baseline
Pain in lying position	Visual analog scale graduated 0-100	Baseline
Pain in standing position	Visual analog scale graduated 0-100	Baseline
Pain during walking	Visual analog scale graduated 0-100	Baseline
Pain when coughing or sneezing	Visual analog scale graduated 0-100	Baseline
Mean pain perceived in the last 48 hours	Visual analog scale graduated 0-10	Baseline
Worst pain perceived in the last 48 hours	Visual analog scale graduated 0-10	Baseline
Lumbar and Hip Mobility	Goniometric measurements in degree	Baseline
Screening or diagnostic tests of lumbar instability	Clinical tests. Dichotomous scale (+/-)	Baseline
Endurance of the extensor muscles of the trunk	Biering-Sorensen test. Holding time in second	Baseline
Endurance of the anterior abdominal muscles of the trunk	Abdominal endurance test. Holding time in second	Baseline
Endurance of the lateral muscles of the trunk	Lateral plank test. Holding time in second	Baseline

Collaborators and Investigators

• Sponsor: Marc Perron
• Collaborators: Canadian Forces Health Services Centre Ottawa
• Investigators: Principal Investigator: Marc Perron, M.Sc., Laval University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2013
• Primary Completion (Actual): March 14, 2015
• Study Completion (Actual): April 27, 2015

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2018
• Last Update Submitted That Met QC Criteria: March 13, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2012-13-#14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The dataset used and/or analysed during the current study is available from the corresponding author on request
• IPD Sharing Time Frame: upon publication
• IPD Sharing Access Criteria: on request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No