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Association Between Low Back Pain and Quality of Sleep

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ClinicalTrials.gov Identifier: NCT00906152
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : March 13, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Quality of Sleep Subacute or Chronic Low Back Pain Disability Catastrophizing Depression

Study Design

Study Type : Observational
Actual Enrollment : 437 participants
Time Perspective: Prospective
Official Title: Study of the Association Between Low Back Pain and the Quality of Sleep
Study Start Date : September 2009
Primary Completion Date : August 2012
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seen for low back pain in the primary care centers participating in the study.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00906152


Locations
Spain
Kovacs Foundation
Palma de Mallorca, Balearic Islands, Spain, 07012
Hospital Ramón y Cajal
Madrid, Spain, 28034
Sponsors and Collaborators
Kovacs Foundation
Investigators
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
More Information

Publications:
Responsible Party: Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation, Kovacs Foundation
ClinicalTrials.gov Identifier: NCT00906152     History of Changes
Other Study ID Numbers: FK-29
First Posted: May 21, 2009    Key Record Dates
Last Update Posted: March 13, 2014
Last Verified: March 2014

Keywords provided by Francisco M. Kovacs, Kovacs Foundation:
quality of sleep
low back pain
disability
catastrophizing
depression

Additional relevant MeSH terms:
Depression
Back Pain
Low Back Pain
Behavioral Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms