Prognostic Factors of Disabling Low Back Pain in Patients With Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02226692
• Other study ID #: UQTR-2011-PFAC
• Status: Completed
• Phase: N/A
• First received: August 12, 2014
• Last updated: May 26, 2015
• Start date: October 2011
• Est. completion date: September 2014

Study information

• Verified date: May 2015
• Source: Université du Québec à Trois-Rivières
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain
• Mechanical Low Back Pain

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	Fonds de la Recherche en Santé du Québec, 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	Disability level	Oswestry disability index	2 months	No
Primary	Disability level	Oswestry disability index	4 months	No
Primary	Disability level	Oswestry disability index	6 months	No
Primary	Disability level	Oswestry disability index	12 months	No
Secondary	Pain intensity in the past 2 months	101 points numerical rating scale	2 months	No
Secondary	Fear of movement level	Tampa scale for kinesiophobia	2 months	No
Secondary	Patient's global impression of change from baseline	Patient's global impression of change scale	6 months	No
Secondary	Patient's global impression of change from 6 months	Patient's global impression of change scale	12 months	No
Secondary	Pain intensity in the past 2 months	101 points numerical rating scale	4 months	No
Secondary	Pain intensity in the past 2 months	101 points numerical rating scale	6 months	No
Secondary	Pain intensity in the past 6 months	101 points numerical rating scale	12 months	No
Secondary	Pain intensity in the past week	101 points numerical rating scale	12 months	No
Secondary	Fear of movement level	Tampa scale for kinesiophobia	4 months	No
Secondary	Fear of movement level	Tampa scale for kinesiophobia	6 months	No
Secondary	Fear of movement level	Tampa scale for kinesiophobia	12 months	No