NCT02226692

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 12, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 27, 2014

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

2.8 years

First QC Date

August 12, 2014

Last Update Submit

May 26, 2015

Conditions

Keywords

chronic low back painprognostic factorsdisabling low back painlumbar muscle activitystart back screening toolphysical evaluation

Outcome Measures

Primary Outcomes (4)

  • Disability level

    Oswestry disability index

    2 months

  • Disability level

    Oswestry disability index

    4 months

  • Disability level

    Oswestry disability index

    6 months

  • Disability level

    Oswestry disability index

    12 months

Secondary Outcomes (11)

  • Pain intensity in the past 2 months

    2 months

  • Fear of movement level

    2 months

  • Patient's global impression of change from baseline

    6 months

  • Patient's global impression of change from 6 months

    12 months

  • Pain intensity in the past 2 months

    4 months

  • +6 more secondary outcomes

Study Arms (1)

nonspecific chronic low back pain

Physical examination and follow-up assessment by questionnaires at 2, 4, 6, and 12 months

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G9A 5H7, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Martin Descarreaux, PhD

    Université du Québec à Trois-Rivières

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Martin Descarreaux DC, PhD

Study Record Dates

First Submitted

August 12, 2014

First Posted

August 27, 2014

Study Start

October 1, 2011

Primary Completion

July 1, 2014

Study Completion

September 1, 2014

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations