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Completed

NCT Number: NCT02226692

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

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.

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Key information

Conditions

Chronic Low Back Pain Back Pain Low Back Pain Mechanical Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G9A 5H7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Disability level

    Time frame: 2 months

    Oswestry disability index

  2. Disability level

    Time frame: 4 months

    Oswestry disability index

  3. Disability level

    Time frame: 6 months

    Oswestry disability index

  4. Disability level

    Time frame: 12 months

    Oswestry disability index

Secondary outcomes

  1. Pain intensity in the past 2 months

    Time frame: 2 months

    101 points numerical rating scale

  2. Fear of movement level

    Time frame: 2 months

    Tampa scale for kinesiophobia

  3. Patient's global impression of change from baseline

    Time frame: 6 months

    Patient's global impression of change scale

  4. Patient's global impression of change from 6 months

    Time frame: 12 months

    Patient's global impression of change scale

  5. Pain intensity in the past 2 months

    Time frame: 4 months

    101 points numerical rating scale

  6. Pain intensity in the past 2 months

    Time frame: 6 months

    101 points numerical rating scale

  7. Pain intensity in the past 6 months

    Time frame: 12 months

    101 points numerical rating scale

  8. Pain intensity in the past week

    Time frame: 12 months

    101 points numerical rating scale

  9. Fear of movement level

    Time frame: 4 months

    Tampa scale for kinesiophobia

  10. Fear of movement level

    Time frame: 6 months

    Tampa scale for kinesiophobia

  11. Fear of movement level

    Time frame: 12 months

    Tampa scale for kinesiophobia

Sponsors and collaborators

Lead sponsor

Université du Québec à Trois-Rivières

Other

Collaborators

  • Fonds de la Recherche en Santé du Québec
  • Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 27, 2014
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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