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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02373345
Other study ID # UQTR-IRSST-2013-2016
Secondary ID
Status Recruiting
Phase N/A
First received February 21, 2015
Last updated February 26, 2015
Start date February 2013
Est. completion date May 2016

Study information

Verified date February 2015
Source Université du Québec à Trois-Rivières
Contact Vincent Cantin, PhD
Phone 819-376-5011
Email vincent.cantin@uqtr.ca
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial 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 .


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

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

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Université du Québec à Trois-Rivières Trois-Rivières Quebec

Sponsors (3)

Lead Sponsor Collaborator
Université du Québec à Trois-Rivières Chaire de recherche en chiropratique FRCQ, Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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