The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity

Manipulation, Spinal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03273868
• Other study ID #: Protocole IFEC 2017-01
• Status: Completed
• Phase: N/A
• Start date: September 11, 2017
• Est. completion date: October 30, 2018

Study information

• Verified date: March 2019
• Source: Institut Franco Europeen de Chiropratique
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Manipulation, Spinal

Intervention

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

Locations

Country	Name	City	State
France	Institut Franco Européen de Chiropraxie	Ivry-sur-Seine	Val De Marne

Sponsors (2)

Lead Sponsor	Collaborator
Institut Franco Europeen de Chiropratique	French chiropractic research fund

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability (HRV)	Frequency and Time-domain analyses of HRV from 5-minutes ECG recording	Baseline, + 5 minutes, + 15 minutes, + 30 minutes
Primary	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	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