Maastricht Neck Study: Cervical Range of Motion in Whiplash Patients (MaNeS)
| Tracking Information | |||||
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| First Received Date ICMJE | August 4, 2009 | ||||
| Last Updated Date | April 19, 2011 | ||||
| Start Date ICMJE | September 2009 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Active- and passive cervical range of motion measured with the 3Space InsideTrak HP system. [ Time Frame: 31-12-2010 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Active- and passive cervical range of motion measured with the 3Space InsideTrak HP system. [ Time Frame: 01-05-2010 ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00952510 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE |
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: 01-05-2010 ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Maastricht Neck Study: Cervical Range of Motion in Whiplash Patients | ||||
| Official Title ICMJE | MaNeS (Maastricht Neck Study): Development of Chronic Disability in Neck Pain Patients After a Motor Vehicle Accident | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE | Whiplash Injuries | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Whiplash patients
The cohort is based on 100 whiplash patients which underwent the measure procedure to obtain cervical range of motion. |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00952510 | ||||
| Other Study ID Numbers ICMJE | MEC 09-2-069 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | J Patijn MD PhD, Maastricht University Medical Center | ||||
| Study Sponsor ICMJE | Maastricht University Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Maastricht University Medical Center | ||||
| Verification Date | April 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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