Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2025-12-25 @ 3:16 PM
Study NCT ID:
NCT03273868
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2017-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity
Sponsor:
Institut Franco Europeen de Chiropratique
Organization:
Study Overview
Official Title:
The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity in Healthy Subjects: a Randomized, Cross-over, Sham-controlled Trial
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
Several systematic reviews have shown that spinal manipulations may have an immediate effect on autonomic nervous system activity (e.g. increase in skin sympathetic nerve activity) and on sensitivity to experimentally-induced pain (e.g. increase in pressure pain threshold).
It is generally unknown i) if these supposed effects last after the immediate post intervention period and ii) if there is a statistical relationship between them, considering that pain and autonomic networks are closely connected and interact at the peripheral, spinal and supra-spinal levels.
The primary aim of the study is to assess every single effect immediatly and at short-term after the intervention.
The secondary aim is to assess the bivariate statistical relationship between cardiovascular autonomic activity and sensitivity to experimentally-induced pain after the intervention.
Cardiovascular autonomic nervous system activity is assessed with both heart rate and systolic blood variabilities
Sensitivity to experimentally-induced pain is measured using pressure pain threshold.
It is generally unknown i) if these supposed effects last after the immediate post intervention period and ii) if there is a statistical relationship between them, considering that pain and autonomic networks are closely connected and interact at the peripheral, spinal and supra-spinal levels.
The primary aim of the study is to assess every single effect immediatly and at short-term after the intervention.
The secondary aim is to assess the bivariate statistical relationship between cardiovascular autonomic activity and sensitivity to experimentally-induced pain after the intervention.
Cardiovascular autonomic nervous system activity is assessed with both heart rate and systolic blood variabilities
Sensitivity to experimentally-induced pain is measured using pressure pain threshold.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: