- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02373345
Clinical and Neuromechanical Predictors for the Evolution of Chronic Non-specific Low Back Pain
May 13, 2016 updated by: Martin Descarreaux, Université du Québec à Trois-Rivières
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 .
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Quebec
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Trois-Rivières, Quebec, Canada, G9A 5H7
- Université du Québec à Trois-Rivières
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Individuals with a history of nonspecific low back pain
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in disability (Roland-Morris Disability Questionnaire)
Time Frame: baseline, 3 months, 6, months. 9 months, 12 months, 15 months, 18 months
|
Roland-Morris Disability Questionnaire
|
baseline, 3 months, 6, months. 9 months, 12 months, 15 months, 18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Martin Descarreaux, DC, PhD, Université du Québec à Trois-Rivières
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
February 21, 2015
First Submitted That Met QC Criteria
February 26, 2015
First Posted (Estimate)
February 27, 2015
Study Record Updates
Last Update Posted (Estimate)
May 17, 2016
Last Update Submitted That Met QC Criteria
May 13, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UQTR-IRSST-2013-2016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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