Heart Rate Variability Modulation Following a Manipulation in Pain Free Patients Versus Patients in Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Activator methods technique
Traditional chiropractic adjustment
Sponsored by
About this trial
This is an interventional basic science trial for Low Back Pain focused on measuring HRV, Activator, Chiropractic, VLF, HF, LF, LF/HF
Eligibility 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
Sites / Locations
- Chiro-clinique Richard Roy
- Dr Richard Roy et Dr Fafard
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
1
2
Arm Description
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.
The investigators had two groups, one for each chiropractic technique used in the research project and we had a control group
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00740558
First Posted
August 22, 2008
Last Updated
August 26, 2008
Sponsor
Université du Québec a Montréal
1. Study Identification
Unique Protocol Identification Number
NCT00740558
Brief Title
Heart Rate Variability Modulation Following a Manipulation in Pain Free Patients Versus Patients in Pain
Official Title
Heart Rate Variability Modulation Following a Manipulation in Pain Free Patients Versus Patients in Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Université du Québec a Montréal
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
HRV, Activator, Chiropractic, VLF, HF, LF, LF/HF
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2
Arm Type
Sham Comparator
Arm Description
The investigators had two groups, one for each chiropractic technique used in the research project and we had a control group
Intervention Type
Procedure
Intervention Name(s)
Activator methods technique
Other Intervention Name(s)
Activator methods
Intervention Description
Chiropractic adjustment by a manually assisted mechanical force
Intervention Type
Procedure
Intervention Name(s)
Traditional chiropractic adjustment
Other Intervention Name(s)
Lumbar roll
Intervention Description
Lumbar roll according to the Diversified technique of chiropractic adjusting
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard A Roy, DCMScPhD(c)
Organizational Affiliation
Université du Québec a Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chiro-clinique Richard Roy
City
La Salle
State/Province
Quebec
ZIP/Postal Code
H8N 1X7
Country
Canada
Facility Name
Dr Richard Roy et Dr Fafard
City
La Salle
State/Province
Quebec
ZIP/Postal Code
H8N1X7
Country
Canada
12. IPD Sharing Statement
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Heart Rate Variability Modulation Following a Manipulation in Pain Free Patients Versus Patients in Pain
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