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CompletedNCT00906152Updated Mar 13, 2014

Association Between Low Back Pain and Quality of Sleep

An observational study in Quality of Sleep, Subacute or Chronic Low Back Pain and Disability, sponsored by Kovacs Foundation. Completed at 2 sites in Spain. Per ClinicalTrials.gov, last updated 2014-03-13.

Sponsored by Kovacs Foundation · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
437
Sex
All
01

Study 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.

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Conditions studied

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

Keywords

  • quality of sleep
  • low back pain
  • disability
  • catastrophizing
  • depression
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 437 is above the median of 100 across 357 observational studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Kovacs Foundation is the lead sponsor of 20 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

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

Time perspective
Prospective
Enrollment
437 participants (actual)

Groups and 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.

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What researchers measure

Primary outcomes

  1. 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

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.

    Time frame: 3 months

07

Study locations

2 sites
  • Kovacs Foundation
    Palma de Mallorca, Balearic Islands 07012, Spain
  • Hospital Ramón y Cajal
    Madrid, 28034, Spain
08

References and documents

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. doi: 10.1007/s00586-004-0731-3. Epub 2004 May 19. PubMed 15150703 ↗
  • Moldofsky H. Sleep and pain. Sleep Med Rev. 2001 Oct;5(5):385-396. doi: 10.1053/smrv.2001.0179. PubMed 12531004 ↗
  • 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. PubMed 17309767 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00906152
Lead sponsor
Kovacs Foundation
Responsible party
Francisco M. Kovacs (Director of Scientific Department, Kovacs Foundation, Kovacs Foundation) — Principal investigator
First posted
May 21, 2009
Start date
Sep 2009
Primary completion
Aug 2012
Completion
May 2013
Last update
Mar 13, 2014

Study contacts

Francisco M Kovacs, MD, PhD
study director · Kovacs Foundation, Palma de Mallorca, 07012, Spain
Víctor Abraira, PhD
principal investigator · Hospital Ramón y Cajal, Unidad de Bioestadística Clínica, Madrid, Spain

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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