The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity

The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity in Healthy Subjects: a Randomized, Cross-over, Sham-controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Manipulation, Spinal
• Intervention / Treatment: Other: High velocity low amplitude manipulation; Other: Sham manipulation

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Val De Marne
    • Ivry-sur-Seine, Val De Marne, France, 94220
      • Institut Franco Européen de Chiropraxie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High velocity low amplitude manipulation	Other: High velocity low amplitude manipulation; The researcher manually applies a preload force on the T5/T6 level followed by a single posterior to anterior thrust.
Sham Comparator: Sham manipulation	Other: Sham manipulation; The researcher manually applies a preload force on the right scapula followed by a single lateral thrust.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut Franco Europeen de Chiropratique
• Collaborators: French chiropractic research fund

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2017
• Primary Completion (Actual): October 30, 2018
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: August 9, 2017
• First Submitted That Met QC Criteria: September 2, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 1, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Protocole IFEC 2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No