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| Sponsor: | Universite du Quebec a Montreal |
|---|---|
| Information provided by: | Universite du Quebec a Montreal |
| ClinicalTrials.gov Identifier: | NCT00740558 |
Purpose
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).
| Condition | Intervention |
|---|---|
|
Low Back Pain |
Procedure: Activator methods technique Procedure: Traditional chiropractic adjustment |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Heart Rate Variability Modulation Following a Manipulation in Pain Free Patients Versus Patients in Pain |
| Enrollment: | 53 |
| Study Start Date: | July 2004 |
| Study Completion Date: | July 2006 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Two groups received a traditional chiropractic adjustment of the lumbar 5 and the other group received a manually assisted mechanical force adjustment of the lumbar 5.
|
Procedure: Activator methods technique
Chiropractic adjustment by a manually assisted mechanical force
Procedure: Traditional chiropractic adjustment
Lumbar roll according to the Diversified technique of chiropractic adjusting
|
|
2: Sham Comparator
The investigators had two groups, one for each chiropractic technique used in the research project and we had a control group
|
Procedure: Activator methods technique
Chiropractic adjustment by a manually assisted mechanical force
Procedure: Traditional chiropractic adjustment
Lumbar roll according to the Diversified technique of chiropractic adjusting
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada, Quebec | |
| Dr Richard Roy et Dr Fafard | |
| La Salle, Quebec, Canada, H8N1X7 | |
| Chiro-clinique Richard Roy | |
| La Salle, Quebec, Canada, H8N 1X7 | |
| Principal Investigator: | Richard A Roy, DCMScPhD(c) | Universite du Quebec a Montreal |
More Information
| Responsible Party: | UQAM ( Dr Richard Roy DCMScPhD(c) ) |
| Study ID Numbers: | 051934 |
| Study First Received: | August 22, 2008 |
| Last Updated: | August 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00740558 History of Changes |
| Health Authority: | Canada: Ethics Review Committee |
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HRV Activator Chiropractic VLF |
HF LF LF/HF |
|
Signs and Symptoms Nervous System Diseases Neurologic Manifestations |
Low Back Pain Pain Back Pain |