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| Tracking Information | |||||
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| First Received Date ICMJE | July 5, 2007 | ||||
| Last Updated Date | July 6, 2007 | ||||
| Start Date ICMJE | December 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Revised Oswestry [ Time Frame: December 2008 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00497861 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of Activator Manipulation Versus Manual Side Posture Manipulation in Patients With Low Back Pain | ||||
| Official Title ICMJE | Comparison of Mechanical Force, Manually Assisted Activator Manipulation Versus Manual Side Posture Manipulation in Patients With Low Back Pain: a Randomized Pilot Study | ||||
| Brief Summary | This study compared the treatment effect of Activator Methods Chiropractic Technique (AMCT) and manual Diversified type spinal manipulative therapy in a sample of patients with acute and sub-acute low back pain. |
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| Detailed Description | The purpose of this study is to compare the effects of (MFMA) Activator instrument adjusting to manual side posture (HVL) adjustments in patients with acute low back pain. Primary outcomes measured include pain measurement with a VAS scale, the use of the Oswestry pain scale questionnaire, and the Bournemouth back pain scale questionnaire. An additional aim of this study is to evaluate feasibility of recruitment, data collection, and other procedures which can lead to additional studies with larger number of subjects including a control group. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Back Pain | ||||
| Intervention ICMJE | Procedure: Activator Methods Chiropractic Technique | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 40 | ||||
| Completion Date | April 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Exclusion criteria consisted of the following:
The criteria described above were intended to minimize the likelihood of including subjects with a lumbar disc herniation. |
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| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00497861 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | MPMFMA1 | ||||
| Study Sponsor ICMJE | Cleveland Chiropractic College | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Cleveland Chiropractic College | ||||
| Verification Date | April 2007 | ||||
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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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