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

This study has been terminated.
(Respond was to low.)
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00952510
First received: August 4, 2009
Last updated: April 19, 2011
Last verified: April 2011
  Purpose

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
Whiplash Injuries

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Active- and passive cervical range of motion measured with the 3Space InsideTrak HP system. [ Time Frame: 31-12-2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 31-12-2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Whiplash patients
The cohort is based on 100 whiplash patients which underwent the measure procedure to obtain cervical range of motion.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00952510

Locations
Netherlands
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
  More Information

No publications provided

Responsible Party: J Patijn MD PhD, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00952510     History of Changes
Other Study ID Numbers: MEC 09-2-069
Study First Received: August 4, 2009
Last Updated: April 19, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Range of motion, articular
Cervical spine

Additional relevant MeSH terms:
Whiplash Injuries
Wounds and Injuries
Neck Injuries

ClinicalTrials.gov processed this record on July 26, 2014