Chronic Neck PainNCT00907049
Association Between Neck Pain and Quality of Sleep
An observational study of Chronic Neck Pain and Disability, 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 neck pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Neck Pain, Disability
- How many people
- 424 participants
- Where
- 2 sitesSpain
- Study dates
- Sep 2009to Jun 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 neck pain in the primary care centers participating in the study.
Who may be able to join
- patients with nonspecific neck pain of more than 14 days duration
- seen in health centers participating in the study
- patients 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 Neck 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 neck 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
- Chronic Neck Pain, Disability
- Keywords
- quality of sleep, neck pain, disability, catastrophizing, depression
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Neck Pain, Depression
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 neck pain; chronic neck pain | Patients with subacute or chronic neck 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 neck pain and quality of sleep in patients with subacute or chronic nonspecific neck 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 nonspecific neck 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 posted22 May 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2013
- Study completionJun 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 Chronic Neck PainStudies 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
- 424 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
- NCT00907049
- Sponsor's protocol ID
- FK-30
- Status last verified
- Mar 2014
- First submitted
- 21 May 2009
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fejer R, Kyvik KO, Hartvigsen J. The prevalence of neck pain in the world population: a systematic critical review of the literature. Eur Spine J. 2006 Jun;15(6):834-48. doi: 10.1007/s00586-004-0864-4. Epub 2005 Jul 6.
PubMed 15999284Moldofsky H. Sleep and pain. Sleep Med Rev. 2001 Oct;5(5):385-396. doi: 10.1053/smrv.2001.0179.
PubMed 12531004McCracken LM, Iverson GL. Disrupted sleep patterns and daily functioning in patients with chronic pain. Pain Res Manag. 2002 Summer;7(2):75-9. doi: 10.1155/2002/579425.
PubMed 12185371
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 Neck Pain and the Quality of Sleep
- ClinicalTrials.gov ID
- NCT00907049
- Acronym / sponsor ID
- FK-30
- Conditions
- Chronic Neck Pain, Disability
- Keywords
- quality of sleep, neck pain, disability, catastrophizing, depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- Kovacs FoundationUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 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 neck 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 neck pain; chronic neck pain | – | –Patients with subacute or chronic neck 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 neck pain in the primary care centers participating in the study.
Key inclusion criteria (4 listed)
- patients with nonspecific neck pain of more than 14 days duration
- seen in health centers participating in the study
- patients 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 neck pain and quality of sleep in patients with subacute or chronic nonspecific neck 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 nonspecific neck 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 15999284Fejer R, Kyvik KO, Hartvigsen J. The prevalence of neck pain in the world population: a systematic critical review of the literature. Eur Spine J. 2006 Jun;15(6):834-48. doi: 10.1007/s00586-004-0864-4. Epub 2005 Jul 6.
- Background: PubMed 12531004Moldofsky H. Sleep and pain. Sleep Med Rev. 2001 Oct;5(5):385-396. doi: 10.1053/smrv.2001.0179.
- Background: PubMed 12185371McCracken LM, Iverson GL. Disrupted sleep patterns and daily functioning in patients with chronic pain. Pain Res Manag. 2002 Summer;7(2):75-9. doi: 10.1155/2002/579425.
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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 Chronic Neck Pain and Disability, 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 neck pain and quality of sleep in patients with subacute or chronic nonspecific neck 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 NCT00907049, 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.