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

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.

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

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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