Association Between Low Back Pain and Quality of Sleep

• Sponsor: Kovacs Foundation (Other)
• Overall Status: Completed
• CT.gov ID: NCT00906152
• Collaborator: (none)
• Enrollment: 437
• Locations: 2
• Duration (Months): 44
• Patients Per Site: 218.5
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Quality of Sleep; Subacute or Chronic Low Back Pain; Disability; Catastrophizing; Depression

Study Design

• Study Type: Observational
• Actual Enrollment: 437 participants
• Time Perspective: Prospective
• Official Title: Study of the Association Between Low Back Pain and the Quality of Sleep
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Assessment of the association between low back pain and quality of sleep in patients with subacute or chronic low back pain. [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 low back pain. [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kovacs Foundation	Palma de Mallorca	Balearic Islands	Spain	07012
2	Hospital Ramón y Cajal	Madrid		Spain	28034

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation, Kovacs Foundation
• ClinicalTrials.gov Identifier: NCT00906152
• Other Study ID Numbers: FK-29
• First Posted: May 21, 2009
• Last Update Posted: Mar 13, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation, Kovacs Foundation: quality of sleep; low back pain; disability; catastrophizing; depression
• Additional relevant MeSH terms: Back Pain; Low Back Pain; Depression

Study Results

No Results Posted as of Mar 13, 2014