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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00907049
Other study ID # FK-30
Secondary ID
Status Completed
Phase N/A
First received May 21, 2009
Last updated March 11, 2014
Start date September 2009
Est. completion date June 2013

Study information

Verified date March 2014
Source Kovacs Foundation
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 424
Est. completion date June 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- inability to complete the questionnaires (illiteracy, dementia)

- inflammatory rheumatologic disease, fibromyalgia, cancer in last 5 years

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Spain Hospital Ramón y Cajal Madrid
Spain Kovacs Foundation Palma de Mallorca Balearic Islands

Sponsors (1)

Lead Sponsor Collaborator
Kovacs Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. Epub 2005 Jul 6. Review. — View Citation

McCracken LM, Iverson GL. Disrupted sleep patterns and daily functioning in patients with chronic pain. Pain Res Manag. 2002 Summer;7(2):75-9. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of the association between neck pain and quality of sleep in patients with subacute or chronic nonspecific neck pain. 3 months No
Secondary Assessment of the association between quality of sleep and disability, catastrophizing and depression in patients with subacute or chronic nonspecific neck pain. 3 months No
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