Maastricht Neck Study: Cervical Range of Motion in Whiplash Patients

Whiplash Injuries Clinical Trial

— MaNeS  

Official title:

MaNeS (Maastricht Neck Study): Development of Chronic Disability in Neck Pain Patients After a Motor Vehicle Accident

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00952510
• Other study ID #: MEC 09-2-069
• Status: Terminated
• Phase: N/A
• First received: August 4, 2009
• Last updated: April 19, 2011
• Start date: September 2009
• Est. completion date: December 2010

Study information

• Verified date: April 2011
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Whiplash Injuries

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Active- and passive cervical range of motion measured with the 3Space InsideTrak HP system.		31-12-2010	No
Secondary	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	No