Clinical trial NCT02226692: Prognostic Factors of Disabling Low Back Pain in Patients With Chronic Low Back Pain
Official title: Risk of Poor Prognosis in Patients With Chronic Low Back Pain : Can it be Predicted by Physical Tests and Screening Tools ? - An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low Back Pain
Mechanical Low Back Pain
Keywords: chronic low back pain
prognostic factors
disabling low back pain
lumbar muscle activity
start back screening tool
physical evaluation
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
name: Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail
First posted: 2014-08-27
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Disability level
timeFrame: 2 months
measure: Disability level
timeFrame: 4 months
measure: Disability level
timeFrame: 6 months
measure: Disability level
timeFrame: 12 months
Secondary outcomes:
measure: Pain intensity in the past 2 months
timeFrame: 2 months
measure: Fear of movement level
timeFrame: 2 months
measure: Patient's global impression of change from baseline
timeFrame: 6 months
measure: Patient's global impression of change from 6 months
timeFrame: 12 months
measure: Pain intensity in the past 2 months
timeFrame: 4 months
measure: Pain intensity in the past 2 months
timeFrame: 6 months
measure: Pain intensity in the past 6 months
timeFrame: 12 months
measure: Pain intensity in the past week
timeFrame: 12 months
measure: Fear of movement level
timeFrame: 4 months
measure: Fear of movement level
timeFrame: 6 months
measure: Fear of movement level
timeFrame: 12 months
Other outcomes:
Locations:
city: Trois-Rivières
country: Canada
facility: Université du Québec à Trois-Rivières
state: Quebec
Study officials:
affiliation: Université du Québec à Trois-Rivières
name: Martin Descarreaux, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Page I, Abboud J, O Shaughnessy J, Laurencelle L, Descarreaux M. Chronic low back pain clinical outcomes present higher associations with the STarT Back Screening Tool than with physiologic measures: a 12-month cohort study. BMC Musculoskelet Disord. 2015 Aug 19;16:201. doi: 10.1186/s12891-015-0669-0.