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

NCT ID: NCT03464877

Last Updated: 2018-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-19
• Study Completion Date: 2015-04-27

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Multi-station full-body supervised exercise program

Intervention Type: 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).

Interventions

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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Forces Health Services Centre Ottawa

OTHER

Sponsor Role: collaborator

Marc Perron

OTHER

Sponsor Role: lead

Responsible Party

Marc Perron

Professor of clinic

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marc Perron, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

Laval University

Québec, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 29606114 (View on PubMed)

Other Identifiers

2012-13-#14

Identifier Type: -

Identifier Source: org_study_id