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
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Heart Rate Variability Modulation Following a Manipulation in Pain Free Patients Versus Patients in Pain

Resource links provided by NLM:


Further study details as provided by Universite du Quebec a Montreal:

Primary Outcome Measures:
  • 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 ]

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
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.
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
Sham Comparator: 2
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
Other Name: Activator methods
Procedure: Traditional chiropractic adjustment
Lumbar roll according to the Diversified technique of chiropractic adjusting
Other Name: Lumbar roll

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740558

Locations
Canada, Quebec
Dr Richard Roy et Dr Fafard
La Salle, Quebec, Canada, H8N1X7
Chiro-clinique Richard Roy
La Salle, Quebec, Canada, H8N 1X7
Sponsors and Collaborators
Universite du Quebec a Montreal
Investigators
Principal Investigator: Richard A Roy, DCMScPhD(c) Universite du Quebec a Montreal
  More Information

No publications provided

Responsible Party: Dr Richard Roy DCMScPhD(c), UQAM
ClinicalTrials.gov Identifier: NCT00740558     History of Changes
Other Study ID Numbers: 051934
Study First Received: August 22, 2008
Last Updated: August 26, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by Universite du Quebec a Montreal:
HRV
Activator
Chiropractic
VLF
HF
LF
LF/HF

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014