Association Between Low Back Pain and Quality of Sleep

Sponsor
Kovacs Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT00906152
Collaborator
(none)
437
2
44
218.5
5

Study Details

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 Intervention/Treatment Phase

    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 :
    Sep 1, 2009
    Actual Primary Completion Date :
    Aug 1, 2012
    Actual Study Completion Date :
    May 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    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. [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. [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Kovacs Foundation Palma de Mallorca Balearic Islands Spain 07012
    2 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation, Kovacs Foundation
    ClinicalTrials.gov Identifier:
    NCT00906152
    Other Study ID Numbers:
    • FK-29
    First Posted:
    May 21, 2009
    Last Update Posted:
    Mar 13, 2014
    Last Verified:
    Mar 1, 2014
    Keywords provided by Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation, Kovacs Foundation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 13, 2014