The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity

Not Applicable

Completed

• Conditions: Manipulation, Spinal
• Interventions: Other: Sham manipulation; Other: High velocity low amplitude manipulation

• Registration Number: NCT03273868
• Lead Sponsor: Institut Franco Europeen de Chiropratique

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.

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.

Study Timeline

• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-09-02
• Study First Posted: 2017-09-06
• Study Start: 2017-09-11
• Primary Completion: 2018-10-30
• Study Completion: 2018-10-30
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-01
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• First-year chiropractic student at IFEC
• Volunteer
• Healthy (no pain, no disease)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham manipulation	Sham manipulation	-
High velocity low amplitude manipulation	High velocity low amplitude manipulation	-

Primary Outcome Measures

Name	Time	Method
Heart rate variability (HRV)	Baseline, + 5 minutes, + 15 minutes, + 30 minutes	Frequency and Time-domain analyses of HRV from 5-minutes ECG recording
Local (T5) and distal (L4) Pressure pain thresholds (PPT)	Baseline, immediatly after intervention, + 12 minutes, + 25 minutes, + 35 minutes	The mean of 3 successives PPT in kilopascal

Secondary Outcome Measures

Name	Time	Method
Systolic blood pressure variability	Baseline, + 5 minutes, + 15 minutes, + 30 minutes	Frequency analysis in the low frequency band of systolic blood pressure variability from 5-minutes recording

Trial Locations

Locations (1)

Institut Franco Européen de Chiropraxie; 🇫🇷 Ivry-sur-Seine, Val De Marne, France