Relative Effectiveness and Adverse Effects of Cervical Manipulation, Mobilisation and the Activator Instrument in Patients With Sub-acute Non-specific Neck Pain: a Pragmatic Randomised Trial
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| First Received Date ICMJE | December 9, 2009 | ||||
| Last Updated Date | December 9, 2009 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Patient Global Impression of Change [ Time Frame: end of treatment, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Relative Effectiveness and Adverse Effects of Cervical Manipulation, Mobilisation and the Activator Instrument in Patients With Sub-acute Non-specific Neck Pain: a Pragmatic Randomised Trial | ||||
| Official Title ICMJE | Neck Pain Comparative Study | ||||
| Brief Summary | The primary purpose of this study was to compare the relative effectiveness of cervical manipulation, mobilisation and the Activator instrument in the treatment of subacute non-specific neck pain. The secondary purpose was to describe any adverse effects of these treatments. |
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| Detailed Description | Neck pain is a common disorder. About 70% of adults will experience neck pain during their lifetime. After low back pain, neck pain is the most common reason patients give for seeking chiropractic care, and the second most common reason for the use of spinal manipulation. Usually, the underlying cause of neck pain is non-specific and cannot be related to a particular pathology as a cause of the presenting symptoms. Due to the uncertainty of the results obtained in the limited number of studies of manipulation and mobilisation for neck pain, further studies are needed to compare the different therapies available for neck pain. Participants in the study were treated as they would normally be with the exception of the type of spinal manipulation. There were three groups: a manipulation group, a mobilisation group, and an Activator instrument group. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Neck Pain | ||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| 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 | Completed | ||||
| Enrollment ICMJE | 47 | ||||
| Completion Date | March 2009 | ||||
| Primary Completion Date | March 2009 (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 64 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01029951 | ||||
| Other Study ID Numbers ICMJE | A.06-2 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Hugh Gemmell Principal Lecturer, Anglo-European College of Chiropractic | ||||
| Study Sponsor ICMJE | Anglo-European College of Chiropractic | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Anglo-European College of Chiropractic | ||||
| Verification Date | July 2006 | ||||
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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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