The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity
1 other identifier
interventional
51
1 country
1
Brief Summary
This study evaluates the effect of a single high-velocity low-amplitude spinal manipulation on both cardiovascular autonomic activity and pressure pain thresholds. It is a cross-over study, thus each participant will undergo both interventions (spinal manipulation and sham manipulation). Both interventions will be separated by a 48 h wash-out period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2017
1 active site
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
First Submitted
Initial submission to the registry
August 9, 2017
CompletedFirst Posted
Study publicly available on registry
September 6, 2017
CompletedStudy Start
First participant enrolled
September 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2018
CompletedMarch 5, 2019
March 1, 2019
1.1 years
August 9, 2017
March 1, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Heart rate variability (HRV)
Frequency and Time-domain analyses of HRV from 5-minutes ECG recording
Baseline, + 5 minutes, + 15 minutes, + 30 minutes
Local (T5) and distal (L4) Pressure pain thresholds (PPT)
The mean of 3 successives PPT in kilopascal
Baseline, immediatly after intervention, + 12 minutes, + 25 minutes, + 35 minutes
Secondary Outcomes (1)
Systolic blood pressure variability
Baseline, + 5 minutes, + 15 minutes, + 30 minutes
Study Arms (2)
High velocity low amplitude manipulation
EXPERIMENTALSham manipulation
SHAM COMPARATORInterventions
The researcher manually applies a preload force on the T5/T6 level followed by a single posterior to anterior thrust.
The researcher manually applies a preload force on the right scapula followed by a single lateral thrust.
Eligibility Criteria
You may qualify if:
- First-year chiropractic student at IFEC
- Volunteer
- Healthy (no pain, no disease)
You may not qualify if:
- Counter indications to spinal manipulation
- Drugs intakes (pain killers or beta-blockers)
- Food, Caffeine and tobacco intakes during the previous hour
- Alcohol intake and performance of strenuous physical activity the day of the experimentation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut Franco Européen de Chiropraxie
Ivry-sur-Seine, Val De Marne, 94220, France
Related Publications (1)
Picchiottino M, Honore M, Leboeuf-Yde C, Gagey O, Cottin F, Hallman DM. The effect of a single spinal manipulation on cardiovascular autonomic activity and the relationship to pressure pain threshold: a randomized, cross-over, sham-controlled trial. Chiropr Man Therap. 2020 Jan 20;28(1):7. doi: 10.1186/s12998-019-0293-4. eCollection 2020.
PMID: 31988711DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chiropractor, PhD student
Study Record Dates
First Submitted
August 9, 2017
First Posted
September 6, 2017
Study Start
September 11, 2017
Primary Completion
October 30, 2018
Study Completion
October 30, 2018
Last Updated
March 5, 2019
Record last verified: 2019-03