Heart Rate Variability Modulation Following a Manipulation in Pain Free Patients Versus Patients in Pain
1 other identifier
interventional
53
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable low-back-pain
Started Jul 2004
Typical duration for not_applicable low-back-pain
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 22, 2008
CompletedFirst Posted
Study publicly available on registry
August 25, 2008
CompletedAugust 27, 2008
August 1, 2008
2 years
August 22, 2008
August 26, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
1
ACTIVE COMPARATORTwo 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.
2
SHAM COMPARATORThe investigators had two groups, one for each chiropractic technique used in the research project and we had a control group
Interventions
Chiropractic adjustment by a manually assisted mechanical force
Lumbar roll according to the Diversified technique of chiropractic adjusting
Eligibility Criteria
You may qualify if:
- Acute low back pain (pain group)
- Maintenance care for the pain free group and the control group
You may not qualify if:
- For the control group (pain)
- For the non pain group pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Chiro-clinique Richard Roy
LaSalle, Quebec, H8N 1X7, Canada
Dr Richard Roy et Dr Fafard
LaSalle, Quebec, H8N1X7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard A Roy, DCMScPhD(c)
Université du Québec a Montréal
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 22, 2008
First Posted
August 25, 2008
Study Start
July 1, 2004
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
August 27, 2008
Record last verified: 2008-08