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
  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:


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 ]

Enrollment: 437
Study Start Date: September 2009
Study Completion Date: May 2013
Primary Completion Date: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 20, 2009
Last Updated: March 11, 2014
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
Low Back Pain
Pain
Depression
Depressive Disorder
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014