HealthyNCT04398160
Bilateral Cervical Manipulation (C3/C4) on Thoracoabdominal Kinematics
A study testing HVLA C3/C4 manipulation in people with Healthy, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HVLA C3/C4 manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers between 18 and 40 years of age.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Bilateral Cervical Manipulation (C3/C4) on Thoracoabdominal Kinematics on Healthy Young Adults: Randomized Controlled Trial (RCT)
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- HVLA C3/C4 manipulation, Sham technique
- Keywords
- Cervical manipulation, Osteopathic manual therapy, Thoracoabdominal kinematics, Qualisys system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HVLA C3/C4 manipulationOther
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.
Sham techniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 minutes after the intervention
Secondary outcomes (4)
Change from Baseline in anterior-to-posterior of the upper ribcage 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 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.
Measured: Immediately after the intervention
Change from Baseline in medial-to-lateral of the lower ribcage 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 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.
Measured: Immediately after the intervention
Change from Baseline in anterior-to-posterior of the upper ribcage 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 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.
Measured: 5 minutes after the intervention
Change from Baseline in medial-to-lateral of the lower ribcage 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 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.
Measured: 5 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study startSep 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natália Maria Oliveira Campelo, Escola Superior de Tecnologia da Saúde do Porto
- Investigators
- Natália MO Campelo, PhD, Principal investigator, Escola Superior de Tecnologia da Saúde do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398160
- Sponsor's protocol ID
- OST1-003
- Status last verified
- Apr 2024
- First submitted
- 18 May 2020
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29503686Boussuges 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.
PubMed 19017880Hutting 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.
PubMed 29153924Kranenburg 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.
PubMed 28171776de 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.
PubMed 21621722Moser 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.
PubMed 31142519Bordoni 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.
PubMed 26586951Goyal 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.
PubMed 28808371Taylor 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.
PubMed 18328937Perry 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.
PubMed 21106433Mesquita 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.
PubMed 30107366Anderst 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.
PubMed 30142458de 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Bilateral Cervical Manipulation (C3/C4) on Thoracoabdominal Kinematics on Healthy Young Adults: Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT04398160
- Acronym / sponsor ID
- OST1-003
- Conditions
- Healthy
- Keywords
- Cervical manipulation, Osteopathic manual therapy, Thoracoabdominal kinematics, Qualisys system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HVLA manipulation | Experimental | Other: HVLA C3/C4 manipulationIn 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. |
| Sham technique | Sham comparator | Other: Sham techniqueThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Volunteers between 18 and 40 years of age.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HVLA C3/C4 manipulationThe 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. | Other | HVLA manipulation |
| Sham techniqueThe 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. | Other | Sham technique |
Primary outcome
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.
4 secondary outcomes
Change from Baseline in anterior-to-posterior of the upper ribcage right after the intervention
Time frame: Immediately after the intervention
Change from Baseline in medial-to-lateral of the lower ribcage right after the intervention
Time frame: Immediately after the intervention
Change from Baseline in anterior-to-posterior of the upper ribcage 5 minutes after the intervention
Time frame: 5 minutes after the intervention
Change from Baseline in medial-to-lateral of the lower ribcage 5 minutes after the intervention
Time frame: 5 minutes after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 29503686Siribumrungwong 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.
- Background: PubMed 19017880Boussuges 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.
- Background: PubMed 29153924Hutting 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.
- Background: PubMed 28171776Kranenburg 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.
- Background: PubMed 21621722de 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.
- Background: PubMed 31142519Moser 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.
- Background: PubMed 26586951Bordoni 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.
- Results publication: PubMed 28808371Goyal 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.
- Results publication: PubMed 18328937Taylor 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.
- Results publication: PubMed 21106433Perry 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.
- Results publication: PubMed 30107366Mesquita 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.
- Results publication: PubMed 30142458Anderst 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natália MO Campelo, PhD principal investigator
Escola Superior de Tecnologia da Saúde do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HVLA C3/C4 manipulation in people with Healthy, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natália MO Campelo, PhD (00351 22 206 1000, ncampelo.estsp.ipp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in anterior-to-posterior of the abdomen right after the intervention (time frame: Immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04398160, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.