NCT02373345

Brief Summary

The purpose of the present study is to determine the association between factors known to be associated with the development of chronic low back pain (psychological and biological) and the evolution of functional disability in individuals with a history of low back pain. To do so, 100 individuals with a history of nonspecific low back pain will be followed over a period of 18 months. During this time frame, participants will be evaluated three times in the laboratory (initial, at 6 months and at 18 months) to determine pain and tolerance thresholds, pain inhibition processes as well as neuromuscular activation. Moreover, these participants will be assessed every three months (initial, 3, 6, 9 12, 15 and 18 months) for functional disability and pain intensity levels of their low back pain as well as for psychological symptoms usually associated with the development of chronic low back pain. It is hypothesized that high psychological symptoms measured initially will be associated with high functional disability throughout the study .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2013

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

February 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

2.8 years

First QC Date

February 21, 2015

Last Update Submit

May 13, 2016

Conditions

Keywords

psychological factorsfunctional disabilitypain thresholdstolerance thresholdsmotor adaptationsnatural course

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in disability (Roland-Morris Disability Questionnaire)

    Roland-Morris Disability Questionnaire

    baseline, 3 months, 6, months. 9 months, 12 months, 15 months, 18 months

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals with a history of nonspecific low back pain

You may qualify if:

  • To have experienced at least one episode of disabling (resulting in loss of work or modified tasks at work) nonspecific low back pain in the past three years.

You may not qualify if:

  • Specific causes of low back pain, arthritic conditions, other chronic pain conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G9A 5H7, Canada

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Martin Descarreaux, DC, PhD

    Université du Québec à Trois-Rivières

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DC, PhD

Study Record Dates

First Submitted

February 21, 2015

First Posted

February 27, 2015

Study Start

February 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations