Association Between Low Back Pain and Quality of Sleep

Depression Clinical Trial

Official title:

Study of the Association Between Low Back Pain and the Quality of Sleep

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00906152
• Other study ID #: FK-29
• Status: Completed
• Phase: N/A
• First received: May 20, 2009
• Last updated: March 11, 2014
• Start date: September 2009
• Est. completion date: May 2013

Study information

• Verified date: March 2014
• Source: Kovacs Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 437
• Est. completion date: May 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Spain	Hospital Ramón y Cajal	Madrid
Spain	Kovacs Foundation	Palma de Mallorca	Balearic Islands

Sponsors (1)

Lead Sponsor	Collaborator
Kovacs Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. Epub 2004 May 19. — View Citation

Moldofsky H. Sleep and pain. Sleep Med Rev. 2001 Oct;5(5):385-396. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the association between low back pain and quality of sleep in patients with subacute or chronic low back pain.		3 months	No
Secondary	Assessment of the association between quality of sleep and disability, catastrophizing and depression in patients with subacute or chronic low back pain.		3 months	No