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Incidence Major Adverse Events following Cervical Spinal Manipulations


- candidate number24038
- NTR NumberNTR5698
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-feb-2016
- Secondary IDs201600164 UMCG Research Register
- Public TitleIncidence Major Adverse Events following Cervical Spinal Manipulations
- Scientific TitleIncidence of Adverse Events after Cervical Manipulative Therapy: a prospective cohort study.
- ACRONYMMCM
- hypothesisThe primary objective of this study was to determine incidence rates of MAE following CSM performed by different manipulative clinicians in The Netherlands. Secondly, to inventory factors of patient and clinicians which might influence the occurrence of MAE following CSM and compare these with a control group of patients.
- Healt Condition(s) or Problem(s) studiedMajor Adverse Events, Cervical Spinal Manipulations
- Inclusion criteriaPatients with MAE following Cervical Spinal Manipulation treated by Manual Therapists, Chiropractors, Osteopaths or Manual physicians.
- Exclusion criteriaPatient younger than 18 years. More than 4 weeks between manipulations and the start of signs /symptoms.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jun-2016
- planned closingdate30-jun-2017
- Target number of participants1000
- InterventionsCervical Spinal Manipulation (HVLA)
- Primary outcomeIncidence of Major Adverse Events (MAE) following cervical spinal manipulation.

MAE as defined by the Dutch Health Care Inspectorate
- Secondary outcomePatientcharacteristics
- TimepointsMeasurements from 01-06-2016 until 30-06-2017
- Trial web sitewww.cervicalemanipulaties.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES H.A. Kranenburg
- CONTACT for SCIENTIFIC QUERIES H.A. Kranenburg
- Sponsor/Initiator Hanze Hogeschool Groningen
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- Publications
- Brief summaryMajor Adverse Events (MAE) following Cervical Spinal Manipulations (CSM) have been described anecdotally and are frequently discussed. Until now, exact incidence rates are unknown. Thereby, there are doubts concerning the factors which may play a role in the occurrence of Adverse Events (AE).
- Main changes (audit trail)
- RECORD26-feb-2016 - 16-apr-2016


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