- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02226692
Prognostic Factors of Disabling Low Back Pain in Patients With Chronic Low Back Pain
May 26, 2015 updated by: Martin Descarreaux, Université du Québec à Trois-Rivières
Risk of Poor Prognosis in Patients With Chronic Low Back Pain : Can it be Predicted by Physical Tests and Screening Tools ? - An Observational Study
The aim of the present study is to quantify the relative contribution of variables obtained during a physical fitness evaluation and a short screening questionnaire in determining the short-term and long term risk of persistent disabling low back pain in patients with chronic low back pain.
It has been hypothesized that patients with higher physical fitness will present a lower risk of persistent disabling low back pain and so, a lower score on the questionnaire.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
53
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
-
-
Quebec
-
Trois-Rivières, Quebec, Canada, G9A 5H7
- Université du Québec à Trois-Rivières
-
-
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
volunteer with chronic nonspecific low back pain will be recruited among the university's community, its outpatients' chiropractic clinic and through advertisements in the local newspaper.
They will first be screened by clinicians at the outpatients' chiropractic clinic in order to assess for the various inclusion and exclusion criteria.
Description
Inclusion Criteria:
- adults between 18 and 60 years old
- nonspecific low back pain : pain located between the twelfth rib and the inferior gluteal fold for which no specific source of pain could be identified
- chronic low back pain : pain present for 12 weeks or more, and included both constant and recurrent patterns of pain
- able to read and understand French
Exclusion Criteria:
- History of surgery or major trauma to the spine
- Current use of medication known to impair physical effort and pain perception
- Lumbar scoliosis of more than 20°
- Collagenosis, severe osteoporosis
- Neuromuscular disease
- Malignant tumor
- Non-controlled hypertension
- Infection
- Radiculopathy
- Progressive neurologic defect
- Myelopathy
- Lumbar disc hernia
- Pregnancy
- Active lower body injury and/or severe and disabling pain limiting the capacity to undergo the evaluation.
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
Cohorts and Interventions
Group / Cohort |
---|
nonspecific chronic low back pain
Physical examination and follow-up assessment by questionnaires at 2, 4, 6, and 12 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disability level
Time Frame: 2 months
|
Oswestry disability index
|
2 months
|
Disability level
Time Frame: 4 months
|
Oswestry disability index
|
4 months
|
Disability level
Time Frame: 6 months
|
Oswestry disability index
|
6 months
|
Disability level
Time Frame: 12 months
|
Oswestry disability index
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity in the past 2 months
Time Frame: 2 months
|
101 points numerical rating scale
|
2 months
|
Fear of movement level
Time Frame: 2 months
|
Tampa scale for kinesiophobia
|
2 months
|
Patient's global impression of change from baseline
Time Frame: 6 months
|
Patient's global impression of change scale
|
6 months
|
Patient's global impression of change from 6 months
Time Frame: 12 months
|
Patient's global impression of change scale
|
12 months
|
Pain intensity in the past 2 months
Time Frame: 4 months
|
101 points numerical rating scale
|
4 months
|
Pain intensity in the past 2 months
Time Frame: 6 months
|
101 points numerical rating scale
|
6 months
|
Pain intensity in the past 6 months
Time Frame: 12 months
|
101 points numerical rating scale
|
12 months
|
Pain intensity in the past week
Time Frame: 12 months
|
101 points numerical rating scale
|
12 months
|
Fear of movement level
Time Frame: 4 months
|
Tampa scale for kinesiophobia
|
4 months
|
Fear of movement level
Time Frame: 6 months
|
Tampa scale for kinesiophobia
|
6 months
|
Fear of movement level
Time Frame: 12 months
|
Tampa scale for kinesiophobia
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Martin Descarreaux, PhD, Université du Québec à Trois-Rivières
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
October 1, 2011
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
August 12, 2014
First Submitted That Met QC Criteria
August 25, 2014
First Posted (Estimate)
August 27, 2014
Study Record Updates
Last Update Posted (Estimate)
May 27, 2015
Last Update Submitted That Met QC Criteria
May 26, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UQTR-2011-PFAC
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.
Clinical Trials on Chronic Low Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Iran University of Medical SciencesNot yet recruitingLow Back Pain | Chronic Low-back Pain | Chronic Non-specific Low Back Pain | Cupping Therapy
-
Federal University of Minas GeraisRecruitingBack Pain | Low Back Pain | Chronic Low-back Pain | Back Pain Lower Back ChronicBrazil
-
University of Colorado, BoulderNational Institutes of Health (NIH); Radiological Society of North America; Psychophysiologic... and other collaboratorsCompletedChronic Pain | Back Pain Lower Back Chronic | Back Pain, LowUnited States
-
Federal University of ParaíbaCompletedChronic Low Back Pain | Nonspecific Chronic Low Back Pain
-
Presidio Medical, IncRecruitingChronic Pain | Chronic Low-back PainAustralia
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
Spaulding Rehabilitation HospitalHighland Instruments, Inc.Active, not recruitingChronic Pain | Chronic Low Back PainUnited States
-
University of WashingtonNational Center for Complementary and Integrative Health (NCCIH)Active, not recruiting
-
Dan RhonNational Center for Complementary and Integrative Health (NCCIH); 59th Medical... and other collaboratorsRecruitingLow Back Pain | Chronic Pain | Surgery | Back Pain Lower Back Chronic | Back Pain, LowUnited States