Heart Rate Variability Modulation Following a Manipulation in Pain Free Patients Versus Patients in Pain

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Heart Rate Variability Modulation Following a Manipulation in Pain Free Patients Versus Patients in Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: Activator methods technique
* Procedure: Traditional chiropractic adjustment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute low back pain (pain group) Maintenance care for the pain free group and the control group Exclusion Criteria: For the control group (pain) For the non pain group pain

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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<br>* Chiropractic adjustment by a manually assisted mechanical force<br>* Other names: Activator methods;Procedure: Traditional chiropractic adjustment<br>* Lumbar roll according to the Diversified technique of chiropractic adjusting<br>* Other names: Lumbar roll;|
| Sham Comparator: 2<br>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<br>* Chiropractic adjustment by a manually assisted mechanical force<br>* Other names: Activator methods;Procedure: Traditional chiropractic adjustment<br>* Lumbar roll according to the Diversified technique of chiropractic adjusting<br>* Other names: Lumbar roll;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Pre and post measurements of one intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HRV, Activator, Chiropractic, VLF, HF, LF, LF/HF