NCT03097263

Brief Summary

Despite the prevalence of chronic low back pain, functional symptomatology of this disease remains poor and treatment decisions are based mainly on subjective data (importance and pain tolerance). However, there are some experimental elements that involve objective assessment of locomotor capabilities - at forefront objectives which the walking velocity in the evaluation of this pathology in terms of severity of functional impairment. Recent evidence suggest the effectiveness of physical rehabilitation program for improving patients functional capacities and their reintegration in socio-professional life. This retrospective study aims to quantify the evolution of the parameters collected during standardized walking tests performed before and after rehabilitation program. These patients have systematically carry out a comfortable walk test (400m walk test) and a brisk walk test (200m) at the beginning and end of their program. Furthermore, a maximal stress test on a treadmill was performed before the program in order to detect any cardiovascular events and to allow the personalization of the effort level required (target heart rate) during rehabilitation. In this study the evolution of the comfortable and fast speed will be collected and compared with the stress test data, and other measured parameters (functional score of Quebec, muscle Tests Shirado and Sorensen).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

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

January 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

2.8 years

First QC Date

November 3, 2016

Last Update Submit

March 27, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • COMFORTABLE WALKING SPEED (TEST OF 400M)

    4 weeks

Secondary Outcomes (4)

  • 200m fast walk test walking velocity

    4 weeks

  • Quebec score

    4 weeks

  • Shirado test

    4 weeks

  • Sorensen test

    4 weeks

Study Arms (1)

Patients

Patients included for rehabilitation program

Other: Physical Rehabilitation program

Interventions

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Non-specific low back pain patients included for rehabilitation program

You may qualify if:

  • Female or male
  • age between 18 and 70
  • Non-specific low back pain - achieved rehabilitation program

You may not qualify if:

  • inflammatory diseases
  • cancer
  • infectious diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabiltiation department CHU Dijon

Dijon, 21079, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2016

First Posted

March 31, 2017

Study Start

January 1, 2014

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

March 31, 2017

Record last verified: 2017-03

Locations