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MaNeS: Maastricht Neck Study: Cervical Range of Motion in Whiplash Patients

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT00952510
Collaborator
(none)
100
Enrollment
1
Location
15
Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Rationale: Neck complaints are often caused by motor vehicle accidents and particular after rear-end collision. Patients complain about neck pain after a whiplash trauma, which lead to mobility restrictions of the cervical spine. It is estimated that 20% develop a chronic pain disorder after 1 year, called a chronic whiplash syndrome.

Objective: the primary objective is to investigate the natural course of active-and passive range of motion and principally the difference score between active-and passive cervical range of motion after a whiplash trauma. The secondary objectives are: investigate the predictive value of active-and passive range of motion and chronicity. Further, the correlation between the degree of restriction of the active and passive backward flexion and chronicity will be investigated. Finally, the correlation between the possible predictive factors such as pain, ideas and feeling about pain, memory and attention, events of the last year and complaints after the motor vehicle accident and chronicity are examined.

Study design and study population: a prospective cohort of 100 whiplash patients which underwent a measurement of the cervical movements and gave permission to recontact them for further research.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    MaNeS (Maastricht Neck Study): Development of Chronic Disability in Neck Pain Patients After a Motor Vehicle Accident
    Study Start Date :
    Sep 1, 2009
    Actual Primary Completion Date :
    Dec 1, 2010
    Actual Study Completion Date :
    Dec 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Whiplash patients

    The cohort is based on 100 whiplash patients which underwent the measure procedure to obtain cervical range of motion.

    Outcome Measures

    Primary Outcome Measures

    1. Active- and passive cervical range of motion measured with the 3Space InsideTrak HP system. [31-12-2010]

    Secondary Outcome Measures

    1. Investigate the correlation between active- and passive cervical movement restraints and: NRS, TSK, PCS, NDI, CES-D, TAS, EPQ, CFQ, Holmes-Rahe scale, Rand 36, PSS-SR [31-12-2010]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients have had a measurement of the cervical range of motion.
    Exclusion Criteria:
    • None.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maastricht University Medical Center Maastricht Limburg Netherlands 6202 AZ

    Sponsors and Collaborators

    • Maastricht University Medical Center

    Investigators

    • Principal Investigator: Jacob Patijn, dr., Maastricht University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00952510
    Other Study ID Numbers:
    • MEC 09-2-069
    First Posted:
    Aug 6, 2009
    Last Update Posted:
    Apr 20, 2011
    Last Verified:
    Apr 1, 2011
    Keywords provided by , ,
    Range of motion, articular
    Cervical spine
    Additional relevant MeSH terms:
    Whiplash Injuries

    Study Results

    No Results Posted as of Apr 20, 2011