Bilateral Cervical Manipulation (C3/C4) on Thoracoabdominal Kinematics

NCT04398160 | Not Yet Recruiting DMC

• 1 other identifier: OST1-003
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in anterior-to-posterior of the abdomen right 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.

  Immediately after the intervention

• Change from Baseline in anterior-to-posterior of the abdomen 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.

  5 minutes after the intervention

Secondary Outcomes (4)

• Change from Baseline in anterior-to-posterior of the upper ribcage right after the intervention

  Immediately 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 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 5 minutes after the intervention

  5 minutes after the intervention

Study Arms (3)

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.

Other: HVLA C3/C4 manipulation

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.

Other: Sham technique

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.

Interventions

HVLA C3/C4 manipulation OTHER

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.

HVLA manipulation

Sham technique OTHER

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.

Sham technique

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteers between 18 and 40 years of age.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Escola Superior de Tecnologia da Saúde do Porto: lead

Study Sites (1)

Escola Superior da Saúde do Porto

Porto, 4200-072, Portugal

Location

Related Publications (13)

• Siribumrungwong K, Sinchai C, Tangtrakulwanich B, Chaiyamongkol W. Reliability and Accuracy of Palpable Anterior Neck Landmarks for the Identification of Cervical Spinal Levels. Asian Spine J. 2018 Feb;12(1):80-84. doi: 10.4184/asj.2018.12.1.80. Epub 2018 Feb 7.

  PMID: 29503686 BACKGROUND

• Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.

  PMID: 19017880 BACKGROUND

• Hutting N, Kerry R, Coppieters MW, Scholten-Peeters GGM. Considerations to improve the safety of cervical spine manual therapy. Musculoskelet Sci Pract. 2018 Feb;33:41-45. doi: 10.1016/j.msksp.2017.11.003. Epub 2017 Nov 3.

  PMID: 29153924 BACKGROUND

• Kranenburg HA, Schmitt MA, Puentedura EJ, Luijckx GJ, van der Schans CP. Adverse events associated with the use of cervical spine manipulation or mobilization and patient characteristics: A systematic review. Musculoskelet Sci Pract. 2017 Apr;28:32-38. doi: 10.1016/j.msksp.2017.01.008. Epub 2017 Jan 23.

  PMID: 28171776 BACKGROUND

• de Camargo VM, Alburquerque-Sendin F, Berzin F, Stefanelli VC, de Souza DP, Fernandez-de-las-Penas C. Immediate effects on electromyographic activity and pressure pain thresholds after a cervical manipulation in mechanical neck pain: a randomized controlled trial. J Manipulative Physiol Ther. 2011 May;34(4):211-20. doi: 10.1016/j.jmpt.2011.02.002. Epub 2011 Mar 21.

  PMID: 21621722 BACKGROUND

• Moser N, Mior S, Noseworthy M, Cote P, Wells G, Behr M, Triano J. Effect of cervical manipulation on vertebral artery and cerebral haemodynamics in patients with chronic neck pain: a crossover randomised controlled trial. BMJ Open. 2019 May 28;9(5):e025219. doi: 10.1136/bmjopen-2018-025219.

  PMID: 31142519 BACKGROUND

• Bordoni B, Marelli F. The fascial system and exercise intolerance in patients with chronic heart failure: hypothesis of osteopathic treatment. J Multidiscip Healthc. 2015 Oct 30;8:489-94. doi: 10.2147/JMDH.S94702. eCollection 2015.

  PMID: 26586951 BACKGROUND

• Goyal M, Goyal K, Narkeesh K, Samuel AJ, Arumugam N, Chatterjee S, Sharma S. Efficacy of Osteopathic Manipulative Treatment Approach in the Patient with Pulmonary Fibrosis in Critical Care Outpatient Department. Indian J Crit Care Med. 2017 Jul;21(7):469-472. doi: 10.4103/0972-5229.210648.

  PMID: 28808371 RESULT

• Taylor HH, Murphy B. Altered sensorimotor integration with cervical spine manipulation. J Manipulative Physiol Ther. 2008 Feb;31(2):115-26. doi: 10.1016/j.jmpt.2007.12.011.

  PMID: 18328937 RESULT

• Perry J, Green A, Singh S, Watson P. A preliminary investigation into the magnitude of effect of lumbar extension exercises and a segmental rotatory manipulation on sympathetic nervous system activity. Man Ther. 2011 Apr;16(2):190-5. doi: 10.1016/j.math.2010.10.008. Epub 2010 Nov 23.

  PMID: 21106433 RESULT

• Mesquita Montes A, Tam C, Crasto C, Argel de Melo C, Carvalho P, Santos R, Vilarinho R, Vilas-Boas JP. Forward trunk lean with arm support affects the activity of accessory respiratory muscles and thoracoabdominal movement in healthy individuals. Hum Mov Sci. 2018 Oct;61:167-176. doi: 10.1016/j.humov.2018.07.011. Epub 2018 Aug 11.

  PMID: 30107366 RESULT

• Anderst WJ, Gale T, LeVasseur C, Raj S, Gongaware K, Schneider M. Intervertebral kinematics of the cervical spine before, during, and after high-velocity low-amplitude manipulation. Spine J. 2018 Dec;18(12):2333-2342. doi: 10.1016/j.spinee.2018.07.026. Epub 2018 Aug 22.

  PMID: 30142458 RESULT

• de Camargo VM, Alburquerque-Sendín F, Bérzin F, Stefanelli VC, Rodrigues Pedroni C, & Santos K. Immediate Effects of the Ashmore Manipulation Technique C5/C6, in Muscle Activity in patients with Mechanical Neck Pain. European Journal Osteopathy & Clinical Related Research, 2012; 7(1), 2-9.

  RESULT

Study Officials

• Natália MO Campelo, PhD

  Escola Superior de Tecnologia da Saúde do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natália MO Campelo, PhD

CONTACT

00351 22 206 1000; ncampelo.estsp.ipp@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 21, 2020
• Study Start: September 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-04

Locations

PT (1)