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Completed

NCT Number: NCT03273868

The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Franco Européen de Chiropraxie

Ivry-sur-Seine, Val De Marne, 94220, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High velocity low amplitude manipulation

Other

The researcher manually applies a preload force on the T5/T6 level followed by a single posterior to anterior thrust.

Sham Manipulation

Other

The researcher manually applies a preload force on the right scapula followed by a single lateral thrust.

Primary outcomes

  1. Heart rate variability (HRV)

    Time frame: Baseline, + 5 minutes, + 15 minutes, + 30 minutes

    Frequency and Time-domain analyses of HRV from 5-minutes ECG recording

  2. Local (T5) and distal (L4) Pressure pain thresholds (PPT)

    Time frame: Baseline, immediatly after intervention, + 12 minutes, + 25 minutes, + 35 minutes

    The mean of 3 successives PPT in kilopascal

Secondary outcomes

  1. Systolic blood pressure variability

    Time frame: Baseline, + 5 minutes, + 15 minutes, + 30 minutes

    Frequency analysis in the low frequency band of systolic blood pressure variability from 5-minutes recording

Sponsors and collaborators

Lead sponsor

Institut Franco Europeen de Chiropratique

Other

Collaborators

  • French chiropractic research fund

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 6, 2017
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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