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

This study has been completed.
Sponsor:
Information provided by:
Universite du Quebec a Montreal
ClinicalTrials.gov Identifier:
NCT00740558
First received: August 22, 2008
Last updated: August 26, 2008
Last verified: August 2008

August 22, 2008
August 26, 2008
July 2004
July 2006   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00740558 on ClinicalTrials.gov Archive Site
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Heart Rate Variability Modulation Following a Manipulation in Pain Free Patients Versus Patients in Pain
Heart Rate Variability Modulation Following a Manipulation in Pain Free Patients Versus Patients in Pain

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Low Back Pain
  • Procedure: Activator methods technique
    Chiropractic adjustment by a manually assisted mechanical force
    Other Name: Activator methods
  • Procedure: Traditional chiropractic adjustment
    Lumbar roll according to the Diversified technique of chiropractic adjusting
    Other Name: Lumbar roll
  • Active Comparator: 1
    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.
    Interventions:
    • Procedure: Activator methods technique
    • Procedure: Traditional chiropractic adjustment
  • Sham Comparator: 2
    The investigators had two groups, one for each chiropractic technique used in the research project and we had a control group
    Interventions:
    • Procedure: Activator methods technique
    • Procedure: Traditional chiropractic adjustment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
July 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00740558
051934
Yes
Dr Richard Roy DCMScPhD(c), UQAM
Universite du Quebec a Montreal
Not Provided
Principal Investigator: Richard A Roy, DCMScPhD(c) Universite du Quebec a Montreal
Universite du Quebec a Montreal
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP