NCT00952510

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
26 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 20, 2011

Status Verified

April 1, 2011

Enrollment Period

1.2 years

First QC Date

August 4, 2009

Last Update Submit

April 19, 2011

Conditions

Keywords

Range of motion, articularCervical spine

Outcome Measures

Primary Outcomes (1)

  • Active- and passive cervical range of motion measured with the 3Space InsideTrak HP system.

    31-12-2010

Secondary Outcomes (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

Study Arms (1)

Whiplash patients

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population is based on 100 whiplash patients which underwent a measurment of the cervical movements and gave permission to recontact them for further research.

You may qualify if:

  • Patients have had a measurement of the cervical range of motion.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6202 AZ, Netherlands

Location

MeSH Terms

Conditions

Whiplash Injuries

Condition Hierarchy (Ancestors)

Neck InjuriesWounds and Injuries

Study Officials

  • Jacob Patijn, dr.

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2009

First Posted

August 6, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 20, 2011

Record last verified: 2011-04

Locations