Clinical trial NCT03273868: The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity
Official title: The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity in Healthy Subjects: a Randomized, Cross-over, Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Manipulation, Spinal
Lead sponsor: Institut Franco Europeen de Chiropratique
Sponsor class: OTHER
Collaborators: name: French chiropractic research fund
First posted: 2017-09-06
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Heart rate variability (HRV)
timeFrame: Baseline, + 5 minutes, + 15 minutes, + 30 minutes
measure: Local (T5) and distal (L4) Pressure pain thresholds (PPT)
timeFrame: Baseline, immediatly after intervention, + 12 minutes, + 25 minutes, + 35 minutes
Secondary outcomes:
measure: Systolic blood pressure variability
timeFrame: Baseline, + 5 minutes, + 15 minutes, + 30 minutes
Other outcomes:
Locations:
city: Ivry-sur-Seine
country: France
facility: Institut Franco Européen de Chiropraxie
state: Val De Marne
Study officials:
References:
citation: 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.