NCT03464877

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2015

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
Last Updated

March 15, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

February 26, 2018

Last Update Submit

March 13, 2018

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (25)

  • Height of participants

    Baseline

  • Weight of participants

    Baseline

  • Body mass index

    Baseline

  • Fear-Avoidance Beliefs Questionnaire

    Baseline

  • Length of employment in the army

    Baseline

  • +20 more secondary outcomes

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Interventions

Multi-station full-body supervised exercise programOTHER

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 group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • episode of subacute or chronic LBP with or without radiation to the lower limbs
  • minimal score of 17% on the Modified Oswestry Disability Index

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laval University

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (1)

  • 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.

    PMID: 29606114DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marc Perron, M.Sc.

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Prospective cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of clinic

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 14, 2018

Study Start

March 19, 2013

Primary Completion

March 14, 2015

Study Completion

April 27, 2015

Last Updated

March 15, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will share

The dataset used and/or analysed during the current study is available from the corresponding author on request

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
upon publication
Access Criteria
on request

Locations

CA(1)