Association Between Neck Pain and Quality of Sleep

Chronic Neck Pain Clinical Trial

Official title:

Study of the Association Between Neck Pain and the Quality of Sleep

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907049
• Other study ID #: FK-30
• 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

• Chronic Neck Pain
• Disability
• Neck Pain

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