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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464877
• Other study ID #: 2012-13-#14
• Status: Completed
• Phase: N/A
• First received: February 26, 2018
• Last updated: March 13, 2018
• Start date: March 19, 2013
• Est. completion date: April 27, 2015

Study information

• Verified date: March 2018
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: April 27, 2015
• Est. primary completion date: March 14, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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).

Locations

Country	Name	City	State
Canada	Laval University	Quebec City	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Marc Perron	Canadian Forces Health Services Centre Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

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