Association Between Low Back Pain and Quality of Sleep

March 11, 2014 updated by: Francisco M. Kovacs, Kovacs Foundation

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

437

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07012
        • Kovacs Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

May 20, 2009

First Submitted That Met QC Criteria

May 20, 2009

First Posted (Estimate)

May 21, 2009

Study Record Updates

Last Update Posted (Estimate)

March 13, 2014

Last Update Submitted That Met QC Criteria

March 11, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FK-29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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