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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Multi-station full-body supervised exercise program
Sponsored by
Marc Perron
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Laval University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 26, 2018
Last Updated
March 13, 2018
Sponsor
Marc Perron
Collaborators
Canadian Forces Health Services Centre Ottawa
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1. Study Identification

Unique Protocol Identification Number
NCT03464877
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 19, 2013 (Actual)
Primary Completion Date
March 14, 2015 (Actual)
Study Completion Date
April 27, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marc Perron
Collaborators
Canadian Forces Health Services Centre Ottawa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Perron, M.Sc.
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laval University
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
29606114
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.
Results Reference
derived

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

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