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| Tracking Information | |||||
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| First Received Date ICMJE | August 22, 2008 | ||||
| Last Updated Date | August 26, 2008 | ||||
| Start Date ICMJE | July 2004 | ||||
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Mean R-R interval, the number of pairs of adjacent NN intervals differing by more than 50 ms, and the proportion of NN intervals differing by more than 50 ms the very low frequency, the low frequency, the high frequency, the LF/HF ratio [ Time Frame: Pre and post measurements of one intervention ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00740558 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Heart Rate Variability Modulation Following a Manipulation in Pain Free Patients Versus Patients in Pain | ||||
| Official Title ICMJE | Heart Rate Variability Modulation Following a Manipulation in Pain Free Patients Versus Patients in Pain | ||||
| Brief Summary | Background The purpose of this study was to examine the heart rate variability (HRV) in the presence or the absence of pain in the lower back (L5), while receiving chiropractic care. Methods A total of 53 healthy participants were randomly assigned to a control, 2 treatment or 2 sham groups (n = 10 per group). Participants underwent an eight-minute acclimatizing period. The HRV tachygram (RR interval) data were recorded directly into a Suunto watch (model T6). The investigators analyzed the five minute pre-treatment and post treatments intervals. The spectral analysis of the tachygram was performed with the Kubios Software (University of Kuopio, Finland). |
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| Detailed Description | Background The chiropractic profession has in the past utilized research results from other fields of and extrapolated them into their science and clinical interpretation 1-4. More recently, chiropractic researchers looked into autonomic nervous system (ANS) adaptations in an animal model following a mechanical stress to the spinal column 5, a noxious mechanical stimulation 6 or a spinal manipulation 7. In the human model, several investigations have been done to measure modifications of the heart rate variability (HRV) following cervical 8 and thoracic manipulations 9 or in a multisite clinical study 10 where details of the manipulation site were not provided. The site of interest for the chiropractic intervention was defined at the level of the lumbar spine, left and right L-5. This site was selected because most studies 8-10 measuring HRV have used the cervical or thoracic component of the spine. The effect of the lumbar parasympathetic nervous system has not been evaluated. In these studies 8-10, changes were observed in various HRV variables, while in two of those studies 8, 9, where sham groups were included, the sham conditions did not demonstrate any changes in the reported HRV parameters. There are strong indications that HRV is a good marker of ANS activity 19-24. Thus, in the three above mentioned studies, it appears that chiropractic interventions have an effect on the ANS. At present, however, no studies to evaluate whether a lumbar spinal manipulation would produce a change in the HRV have been reported. Thus, the present study seeks to measure the effect of a lumbar adjustment, with a manually assisted mechanical force, producing a chiropractic adjustment, in participants without lumbar pain and a traditional adjustment in participants with lumbar pain on HRV. The hypothesis being that a lumbar intervention would have an acute effect on the ANS as demonstrated by the modulation of HRV variables. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Basic Science, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Low Back Pain | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| 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 | 53 | ||||
| Completion Date | July 2006 | ||||
| Primary Completion Date | July 2006 (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 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00740558 | ||||
| Responsible Party | Dr Richard Roy DCMScPhD(c), UQAM | ||||
| Study ID Numbers ICMJE | 051934 | ||||
| Study Sponsor ICMJE | Universite du Quebec a Montreal | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Universite du Quebec a Montreal | ||||
| Verification Date | August 2008 | ||||
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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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