Association Between Low Back Pain and Quality of Sleep

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Francisco M. Kovacs, Kovacs Foundation
ClinicalTrials.gov Identifier:
NCT00906152
First received: May 20, 2009
Last updated: March 11, 2014
Last verified: March 2014

May 20, 2009
March 11, 2014
September 2009
August 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00906152 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Association Between Low Back Pain and Quality of Sleep
Study of the Association Between Low Back Pain and the 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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients seen for low back pain in the primary care centers participating in the study.

  • Quality of Sleep
  • Subacute or Chronic Low Back Pain
  • Disability
  • Catastrophizing
  • Depression
Not Provided
Subacute low back pain; chronic low back pain
Patients with subacute or chronic low back pain seen in the Primary Care Centers participating in the study.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
437
May 2013
August 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00906152
FK-29
Yes
Francisco M. Kovacs, Kovacs Foundation
Kovacs Foundation
Not Provided
Study Director: Francisco M Kovacs, MD, PhD Kovacs Foundation, Palma de Mallorca, 07012, Spain
Principal Investigator: Víctor Abraira, PhD Hospital Ramón y Cajal, Unidad de Bioestadística Clínica, Madrid, Spain
Kovacs Foundation
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP