The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity

NCT ID: NCT03273868

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-11
• Study Completion Date: 2018-10-30

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.

Conditions

Manipulation, Spinal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

High velocity low amplitude manipulation

Group Type: EXPERIMENTAL

High velocity low amplitude manipulation

Intervention Type: OTHER

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

Sham manipulation

Group Type: SHAM_COMPARATOR

Sham manipulation

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Sham manipulation

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

French chiropractic research fund

UNKNOWN

Sponsor Role: collaborator

Institut Franco Europeen de Chiropratique

OTHER

Sponsor Role: lead

Responsible Party

Mathieu Picchiottino

Chiropractor, PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institut Franco Européen de Chiropraxie

Ivry-sur-Seine, Val De Marne, France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 31988711 (View on PubMed)

Other Identifiers

Protocole IFEC 2017-01

Identifier Type: -

Identifier Source: org_study_id