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Trial record 100 of 130 for:    "Depressive Disorder" [DISEASE] AND Behavioral | ( Map: Spain )

Association Between Low Back 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: NCT00906152
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : March 13, 2014
Sponsor:
Information provided by (Responsible Party):
Francisco M. Kovacs, Kovacs Foundation

Tracking Information
First Submitted Date May 20, 2009
First Posted Date May 21, 2009
Last Update Posted Date March 13, 2014
Study Start Date September 2009
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2009)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00906152 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 20, 2009)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Association Between Low Back Pain and Quality of Sleep
Official Title Study of the Association Between Low Back Pain and the Quality of Sleep
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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients seen for low back pain in the primary care centers participating in the study.
Condition
  • Quality of Sleep
  • Subacute or Chronic Low Back Pain
  • Disability
  • Catastrophizing
  • Depression
Intervention Not Provided
Study 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 11, 2014)
437
Original Estimated Enrollment
 (submitted: May 20, 2009)
420
Actual Study Completion Date May 2013
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT00906152
Other Study ID Numbers FK-29
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Francisco M. Kovacs, Kovacs Foundation
Study Sponsor Kovacs Foundation
Collaborators Not Provided
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
PRS Account Kovacs Foundation
Verification Date March 2014