Quality of SleepNCT00906152
Association Between Low Back Pain and Quality of Sleep
An observational study of Quality of Sleep and Subacute or Chronic Low Back Pain, run by Kovacs Foundation at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Quality of Sleep, Subacute or Chronic Low Back Pain, Disability
- How many people
- 437 participants
- Where
- 2 sitesSpain
- Study dates
- Sep 2009to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients seen for low back pain in the primary care centers participating in the study.
Who may be able to join
- 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
Who cannot join
- inability to complete the questionnaires (illiteracy, dementia)
- inflammatory rheumatologic disease, fibromyalgia, cancer in last 5 years
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Ramón y Cajal
Madrid, Madrid, 28034
Kovacs Foundation
Palma de Mallorca, Balearic Islands, 07012
About this study
Official title: Study of the Association Between Low Back Pain and the Quality of Sleep
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
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the association between low back pain and quality of sleep in patients with subacute or chronic low back pain.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Quality of SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kovacs Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco M. Kovacs, Kovacs Foundation
- Investigators
- Francisco M Kovacs, MD, PhD, Study director, Kovacs Foundation, Palma de Mallorca, 07012, SpainVíctor Abraira, PhD, Principal investigator, Hospital Ramón y Cajal, Unidad de Bioestadística Clínica, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906152
- Sponsor's protocol ID
- FK-29
- Status last verified
- Mar 2014
- First submitted
- 20 May 2009
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
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 15150703Moldofsky H. Sleep and pain. Sleep Med Rev. 2001 Oct;5(5):385-396. doi: 10.1053/smrv.2001.0179.
PubMed 12531004Tang 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Association Between Low Back Pain and the Quality of Sleep
- ClinicalTrials.gov ID
- NCT00906152
- Acronym / sponsor ID
- FK-29
- Conditions
- Quality of Sleep, Subacute or Chronic Low Back Pain, Disability, Catastrophizing, Depression
- Keywords
- quality of sleep, low back pain, disability, catastrophizing, depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- Kovacs FoundationUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients seen for low back pain in the primary care centers participating in the study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- inability to complete the questionnaires (illiteracy, dementia)
- inflammatory rheumatologic disease, fibromyalgia, cancer in last 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
- Background: PubMed 15150703Hansson 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.
- Background: PubMed 12531004Moldofsky H. Sleep and pain. Sleep Med Rev. 2001 Oct;5(5):385-396. doi: 10.1053/smrv.2001.0179.
- Background: PubMed 17309767Tang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Sleep and Subacute or Chronic Low Back Pain, run by Kovacs Foundation at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00906152, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2014.