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Bilateral Cervical Manipulation (C3/C4) on Thoracoabdominal Kinematics

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04398160
Enrollment
90
Registered
2020-05-21
Start date
2024-09-30
Completion date
2024-12-31
Last updated
2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Cervical manipulation, Osteopathic manual therapy, Thoracoabdominal kinematics, Qualisys system

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.

Interventions

OTHERHVLA C3/C4 manipulation

The investigator will apply an anterior and lateral translation associated with extension, homolateral inclination and contralateral rotation of the cervical. This procedure will increase the tension of the soft tissues to reduce the remaining slack and, finally, the thrust will be applied in pure rotation. Subsequently the head of the volunteer will be repositioned in the neutral position without applying any pressure and will wait 10 seconds in this position. Finally, the previous procedure will be repeated to the opposite side.

The investigator will apply an anterior and lateral translation associated with extension, homolateral inclination and contralateral rotation of the cervical until the perception of tissue tension at the point of contact, holding this position for 10 seconds. The investigator then repositions the head of the volunteer in the neutral position without applying pressure, holding again this position for 10 seconds. Finally, the previous procedure will be repeated for the opposite side.

Sponsors

Escola Superior de Tecnologia da Saúde do Porto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in anterior-to-posterior of the abdomen right after the interventionImmediately after the interventionThe 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 intervention5 minutes after the interventionThe 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

MeasureTime frameDescription
Change from Baseline in anterior-to-posterior of the upper ribcage right after the interventionImmediately after the interventionThe 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 xiphoid process of sternum and the spinal process of seventh thoracic vertebra (T7). 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 medial-to-lateral of the lower ribcage right after the interventionImmediately after the interventionThe 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 alignment of the mid-axillar line with the ninth rib bilaterally. 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 upper ribcage 5 minutes after the intervention5 minutes after the interventionThe 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 xiphoid process of sternum and the spinal process of seventh thoracic vertebra (T7). 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 medial-to-lateral of the lower ribcage 5 minutes after the intervention5 minutes after the interventionThe 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 alignment of the mid-axillar line with the ninth rib bilaterally. 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.

Countries

Portugal

Contacts

Primary ContactNatália MO Campelo, PhD
ncampelo.estsp.ipp@gmail.com00351 22 206 1000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026