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OpenTrials
Completed

NCT Number: NCT00906152

Association Between Low Back Pain and Quality of Sleep

A prospective study to assess the association between the change in quality of sleep and the change in intensity of pain in Spanish patients seen for subacute or chronic low back pain. The objective is to determine the prevalence of sleep alterations, the association between quality of sleep and intensity of pain, degree of disability, intensity of catastrophizing and depression.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with non-specific low back pain of more than 14 days duration
  • seen in health centers participating in the study
  • who accept to participate and sign the consent form
  • without age limits and regardless of gender

Exclusion criteria

  • inability to complete the questionnaires (illiteracy, dementia)
  • inflammatory rheumatologic disease, fibromyalgia, cancer in last 5 years

Treatment and study plan

Primary outcomes

  1. Assessment of the association between low back pain and quality of sleep in patients with subacute or chronic low back pain.

    Time frame: 3 months

Secondary outcomes

  1. Assessment of the association between quality of sleep and disability, catastrophizing and depression in patients with subacute or chronic low back pain.

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Kovacs Foundation

Other

Registry information

Official study title

Study of the Association Between Low Back Pain and the Quality of Sleep

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
May 21, 2009
Registry last updated
Mar 13, 2014

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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