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Association Between Neck Pain and Quality of Sleep

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00907049
Recruitment Status : Completed
First Posted : May 22, 2009
Last Update Posted : March 13, 2014
Sponsor:
Information provided by (Responsible Party):
Francisco M. Kovacs, Kovacs Foundation

Study Description
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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 neck 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
Chronic Neck Pain Disability

Study Design
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Study Type : Observational
Actual Enrollment : 424 participants
Time Perspective: Prospective
Official Title: Study of the Association Between Neck Pain and the Quality of Sleep
Study Start Date : September 2009
Actual Primary Completion Date : February 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Subacute neck pain; chronic neck pain
Patients with subacute or chronic neck pain seen in the Primary Care Centers participating in the study.


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of the association between neck pain and quality of sleep in patients with subacute or chronic nonspecific neck pain. [ Time Frame: 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 nonspecific neck pain. [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seen for neck pain in the primary care centers participating in the study.
Criteria

Inclusion Criteria:

  • patients with nonspecific neck pain of more than 14 days duration
  • seen in health centers participating in the study
  • patients 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907049


Locations
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Spain
Kovacs Foundation
Palma de Mallorca, Balearic Islands, Spain, 07012
Hospital Ramón y Cajal
Madrid, Spain, 28034
Sponsors and Collaborators
Kovacs Foundation
Investigators
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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
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Publications:

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Responsible Party: Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation, Kovacs Foundation
ClinicalTrials.gov Identifier: NCT00907049    
Other Study ID Numbers: FK-30
First Posted: May 22, 2009    Key Record Dates
Last Update Posted: March 13, 2014
Last Verified: March 2014
Keywords provided by Francisco M. Kovacs, Kovacs Foundation:
quality of sleep
neck pain
disability
catastrophizing
depression
Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations