Association Between Low Back Pain and Quality of Sleep

NCT ID: NCT00906152

Last Updated: 2014-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

437 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kovacs Foundation

OTHER

Sponsor Role lead

Responsible Party

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Francisco M. Kovacs

Director of Scientific Department, Kovacs Foundation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francisco M Kovacs, MD, PhD

Role: STUDY_DIRECTOR

Kovacs Foundation, Palma de Mallorca, 07012, Spain

Víctor Abraira, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Ramón y Cajal, Unidad de Bioestadística Clínica, Madrid, Spain

Locations

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Kovacs Foundation

Palma de Mallorca, Balearic Islands, Spain

Site Status

Hospital Ramón y Cajal

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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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. doi: 10.1007/s00586-004-0731-3. Epub 2004 May 19.

Reference Type BACKGROUND
PMID: 15150703 (View on PubMed)

Moldofsky H. Sleep and pain. Sleep Med Rev. 2001 Oct;5(5):385-396. doi: 10.1053/smrv.2001.0179.

Reference Type BACKGROUND
PMID: 12531004 (View on PubMed)

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. doi: 10.1111/j.1365-2869.2007.00571.x.

Reference Type BACKGROUND
PMID: 17309767 (View on PubMed)

Other Identifiers

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FK-29

Identifier Type: -

Identifier Source: org_study_id

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