Association Between Low Back Pain and Quality of Sleep

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2009 by Kovacs Foundation.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Kovacs Foundation

ClinicalTrials.gov Identifier:

NCT00906152

First received: May 20, 2009

Last updated: June 26, 2011

Last verified: December 2009

History of Changes

Purpose

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

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Study of the Association Between Low Back Pain and the Quality of Sleep

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Depression

U.S. FDA Resources

Further study details as provided by Kovacs Foundation:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	420
Study Start Date:	September 2009
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

Eligibility

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906152

Contacts

Contact: Francisco M Kovacs, MD, PhD	+34 971 720809	kovacs@kovacs.org
Contact: Maria Teresa Gil del Real, MPH	+34 91 3440244	mtgildelreal@kovacs.org

Locations

Spain
Kovacs Foundation	Recruiting
Palma de Mallorca, Balearic Islands, Spain, 07012
Contact: Francisco M Kovacs, MD, PhD +34 971 720809 kovacs@kovacs.org
Contact: Maria Teresa Gil del Real, MPH +34 91 3440244 mtgildelreal@kovacs.org
Principal Investigator: Francisco M Kovacs, MD, PhD
Hospital Ramón y Cajal	Recruiting
Madrid, Spain, 28034
Contact: Víctor Abraira, PhD +34 91 3368103 victor.abraira@hrc.es
Principal Investigator: Víctor Abraira, PhD

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:

Hansson EK, Hansson TH. The costs for persons sick-listed more than one month because of low back or neck problems. A two-year prospective study of Swedish patients. Eur Spine J. 2005 May;14(4):337-45. Epub 2004 May 19.

Moldofsky H. Sleep and pain. Sleep Med Rev. 2001 Oct;5(5):385-396.

Tang NK, Wright KJ, Salkovskis PM. Prevalence and correlates of clinical insomnia co-occurring with chronic back pain. J Sleep Res. 2007 Mar;16(1):85-95.

Responsible Party:	Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation
ClinicalTrials.gov Identifier:	NCT00906152 History of Changes
Other Study ID Numbers:	FK-29
Study First Received:	May 20, 2009
Last Updated:	June 26, 2011
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Kovacs Foundation:

quality of sleep
low back pain
disability
catastrophizing
depression

Additional relevant MeSH terms:

Back Pain
Depression
Depressive Disorder
Low Back Pain
Pain
Neurologic Manifestations

Nervous System Diseases
Signs and Symptoms
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013

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