Association Between Neck Pain and Quality of Sleep

NCT00907049 | Completed DMC

• 1 other identifier: FK-30
• Study Type: observational
• Target: 424
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Neck Pain; Disability

Keywords

quality of sleep; neck pain; disability; catastrophizing; depression

Outcome Measures

Primary Outcomes (1)

• Assessment of the association between neck pain and quality of sleep in patients with subacute or chronic nonspecific neck pain.

  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.

  3 months

Study Arms (1)

Subacute neck pain; chronic neck pain

Patients with subacute or chronic neck pain seen in the Primary Care Centers participating in the study.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kovacs Foundation: lead

Study Sites (2)

Kovacs Foundation

Palma de Mallorca, Balearic Islands, 07012, Spain

Location

Hospital Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Related 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. doi: 10.1007/s00586-004-0864-4. Epub 2005 Jul 6.

  PMID: 15999284 BACKGROUND

• Moldofsky H. Sleep and pain. Sleep Med Rev. 2001 Oct;5(5):385-396. doi: 10.1053/smrv.2001.0179.

  PMID: 12531004 BACKGROUND

• McCracken 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.

  PMID: 12185371 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Neck Pain; Depression

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Francisco M Kovacs, MD, PhD

  Kovacs Foundation, Palma de Mallorca, 07012, Spain

  STUDY DIRECTOR

• Víctor Abraira, PhD

  Hospital Ramón y Cajal, Unidad de Bioestadística Clínica, Madrid, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Scientific Department, Kovacs Foundation

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: May 22, 2009
• Study Start: September 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 13, 2014

Record last verified: 2014-03

Locations

ES (2)