Association Between Low Back Pain and Quality of Sleep

NCT00906152 | Completed DMC

• 1 other identifier: FK-29
• Study Type: observational
• Target: 437
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

quality of sleep; low back pain; disability; catastrophizing; depression

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen for low back pain in the primary care centers participating in the study.

You may qualify if:

• 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

You may not qualify if:

• inability to complete the questionnaires (illiteracy, dementia)
• inflammatory rheumatologic disease, fibromyalgia, cancer in last 5 years

Sponsors & Collaborators

• Kovacs Foundation: lead

Study Sites (2)

Kovacs Foundation

Palma de Mallorca, Balearic Islands, 07012, Spain

Location

Hospital Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

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

  PMID: 15150703 BACKGROUND

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

  PMID: 12531004 BACKGROUND

• 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.

  PMID: 17309767 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression; Low Back Pain

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Francisco M Kovacs, MD, PhD

  Kovacs Foundation, Palma de Mallorca, 07012, Spain

  STUDY DIRECTOR

• Víctor Abraira, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Scientific Department, Kovacs Foundation

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 21, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: May 1, 2013
• Last Updated: March 13, 2014

Record last verified: 2014-03

Locations

ES (2)