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Clinical Trials/NCT04398160
NCT04398160UnknownNot Applicable

Influence of Bilateral Cervical Manipulation (C3/C4) on Thoracoabdominal Kinematics on Healthy Young Adults: Randomized Controlled Trial (RCT)

Escola Superior de Tecnologia da Saúde do Porto1 site in 1 country90 target enrollmentStarted: September 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
90
Locations
1
Primary Endpoint
Change from Baseline in anterior-to-posterior of the abdomen right after the intervention

Study Overview

Brief Summary

There is evidence of the interdependence between the diaphragm and the C4 vertebral level with regard to nerve, fascial and muscular connections. The purpose of this study is to evaluate the influence of cervical bilateral manipulation (C3/C4) on the thoracoabdominal kinematics in healthy young adults.

Detailed Description

Due to respiration the thoracoabdominal kinematics is considered a complex mechanism that evolves the movement of the ribs and fascia, the diaphragmatic function, the respiratory muscles and the mechanical properties of the airways that includes a coordinated reflex neural activity. The phrenic nerve (C3 to C5) is responsable for the motor and sensory innervation of the diaphragm.

The High Velocity Low Amplitude (HVLA) vertebral manipulation stimulates the corresponding spinal nerves. It is well known that when this manipulation is applied to cervical region induces vasomotor cutaneous and cardiorespiratory modifications in autonomic nervous system.

The sample composed of healthy young adults (aged 18-40 years) will be assigned randomly in three groups: experimental group (bilateral C3/C4 HVLA manipulation), sham manipulation group (passive cervical mobilization) and control group (no intervention). The thoracoabdominal kinematics measures will be assessed at baseline, right after the intervention and five minutes after the second measure using the Qualisys Motion Capture System.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Volunteers between 18 and 40 years of age.

Exclusion Criteria

  • •Attending a degree in Osteopathy or being a health professional in this area;
  • •Apprehension to cervical manipulation;
  • •Be pregnant;
  • •Presenting cervical pain on the day of the study;
  • •Does not comply with the Australian Vertebral Artery Protocol guidelines;
  • •Having a clinical history of cervical and/or thoracoabdominal surgery;
  • •Having a clinical history of cervical trauma during the prior 12 months;
  • •Recurrent use of anti-coagulant and/or analgesic, muscle relaxant or anti-inflammatory therapeutics during the week before the study;
  • •Have been submitted to any manual intervention at cervical region during the week before the study;
  • •Having cardio-respiratory, neurological, rheumatic, oncologic and/or systemic diagnosed pathologies.

Arms & Interventions

HVLA manipulation

Experimental

In the intervention of the experimental group, the investigator will be primarily on the right side of the volunteer and identify C3 through the cervical reference of jaw angle, which is at the disc level between C2/C3 and then contact with the phalanges of third metacarpal in the left transverse of this vertebra.

The volunteer will be seated with 110º of hip and knee flexion using a digital goniometer and will be asked to breath normally.

Intervention: HVLA C3/C4 manipulation (Other)

Sham technique

Sham Comparator

The investigator will be primarily on the right side of the volunteer and identify the C3 vertebra, having as anatomical reference the angle of the jaw, which is at the disc level between C2/C3 and then contact, with the phalanges of the third metacarpal, the left transverse apophysis of this vertebra.

The volunteer will be seated with 110º of hip and knee flexion using a digital goniometer and will be asked to breath normally.

Intervention: Sham technique (Other)

No intervention group

No Intervention

The volunteer will be seated with 110º of hip and knee flexion using a digital goniometer and will be asked to breath normally.

Outcomes

Primary Outcomes

Change from Baseline in anterior-to-posterior of the abdomen right after the intervention

Time Frame: Immediately after the intervention

The Qualysis Motion Capture System will measure the variation of the tridimensional movement of the abdomen through the positioning of two reflectors that will be placed in standardized points: in the umbilicus and the spinal process of L3. The volunteer will be seated with 110º of hip and knee flexion using a digital goniometer and will be asked to breath normally for 90 seconds. This measure instrument have eight infrared cameras which after the calibration process will determine the data of the tridimensional thoracoabdominal amplitude variations of the volunteer by the kinematic of the reflex markers.

Change from Baseline in anterior-to-posterior of the abdomen 5 minutes after the intervention

Time Frame: 5 minutes after the intervention

The Qualysis Motion Capture System will measure the variation of the tridimensional movement of the abdomen through the positioning of two reflectors that will be placed in standardized points: in the umbilicus and the spinal process of L3. The volunteer will be seated with 110º of hip and knee flexion using a digital goniometer and will be asked to breath normally for 90 seconds. This measure instrument have eight infrared cameras which after the calibration process will determine the data of the tridimensional thoracoabdominal amplitude variations of the volunteer by the kinematic of the reflex markers.

Secondary Outcomes

  • Change from Baseline in anterior-to-posterior of the upper ribcage right after the intervention(Immediately after the intervention)
  • Change from Baseline in anterior-to-posterior of the upper ribcage 5 minutes after the intervention(5 minutes after the intervention)
  • Change from Baseline in medial-to-lateral of the lower ribcage right after the intervention(Immediately after the intervention)
  • Change from Baseline in medial-to-lateral of the lower ribcage 5 minutes after the intervention(5 minutes after the intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Natália Maria Oliveira Campelo

Professor

Escola Superior de Tecnologia da Saúde do Porto

Study Sites (1)

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