Clinical trial NCT04398160: Bilateral Cervical Manipulation (C3/C4) on Thoracoabdominal Kinematics
Official title: Influence of Bilateral Cervical Manipulation (C3/C4) on Thoracoabdominal Kinematics on Healthy Young Adults: Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Cervical manipulation
Osteopathic manual therapy
Thoracoabdominal kinematics
Qualisys system
Lead sponsor: Escola Superior de Tecnologia da Saúde do Porto
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in anterior-to-posterior of the abdomen right after the intervention
timeFrame: Immediately after the intervention
measure: Change from Baseline in anterior-to-posterior of the abdomen 5 minutes after the intervention
timeFrame: 5 minutes after the intervention
Secondary outcomes:
measure: Change from Baseline in anterior-to-posterior of the upper ribcage right after the intervention
timeFrame: Immediately after the intervention
measure: Change from Baseline in medial-to-lateral of the lower ribcage right after the intervention
timeFrame: Immediately after the intervention
measure: Change from Baseline in anterior-to-posterior of the upper ribcage 5 minutes after the intervention
timeFrame: 5 minutes after the intervention
measure: Change from Baseline in medial-to-lateral of the lower ribcage 5 minutes after the intervention
timeFrame: 5 minutes after the intervention
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Escola Superior da Saúde do Porto
Study officials:
affiliation: Escola Superior de Tecnologia da Saúde do Porto
name: Natália MO Campelo, PhD
role: PRINCIPAL_INVESTIGATOR
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