Respiratory DiseaseNCT03732222
Stretching of the Diaphragm and Cervical Impulse Technique and Its Possible Spirometric Changes
A study testing Stretching the diaphragm muscle, Impulse technique in rotation of cervical level 3 and 4 and Combined technique of diaphragm muscle stretch and cervical rotation impulse technique level 3 and 4 in people with Respiratory Disease, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
This study investigates the effect of two different techniques, stretching of the diaphragm and cervical level impulse technique C3-C4, in the possible spirometric changes, vital capacity (CV), maximum expiratory flow (PEF) and maximum expiratory volume (FEV). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Disease
- What is being tested?
- Stretching the diaphragm muscle, Impulse technique in rotation of cervical level 3 and 4 and Combined technique of diaphragm muscle stretch and cervical rotation impulse technique level 3 and 4
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteSpain
- Study dates
- 5 Nov 2018to 18 Nov 2018
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Accept participating in the study (signature of informed consent).
- Be in an age range between 18 and 50 years.
- Do not present any exclusion criteria.
Who cannot join
- Do not meet the inclusion criteria.
- Have obstructive and / or restrictive respiratory problems.
- Perfect transient conditions that affect the respiratory tract, such as colds, sinusitis, influenza, respiratory allergies.
- To have a history of rib fractures.
- Congenital deformities.
- To have digestive problems.
Show all 12Show fewer
- Paying hepatitis and / or hepatobiliary lesions.
- Suffer heart disease and / or arterial hypertension.
- Have abdominal problems.
- Provide surgical scar on the abdomen, thorax and / or neck.
- Patience cancer
- Press any type of pain at the time of conducting the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis, Evaluation and Comparison of Spirometric Values After the Application of the Diaphragm Muscle Stretch Technique and the Cervical Level Rotation Impulse Technique of C3-C4
This study investigates the effect of two different techniques, stretching of the diaphragm and cervical level impulse technique C3-C4, in the possible spirometric changes, vital capacity (CV), maximum expiratory flow (PEF) and maximum expiratory volume (FEV). in relation to the secondary variables (age, physical activity, BMI, sex). the subjects of the study were informed and clarified doubts about it and its subsequent reading and signing of informed consent. The subjects were randomly selected to determine which intervention group they would belong to (G1: intervention group of the diaphragm muscle stretch technique, G2: intervention group of the cervical rotation rotation impulse technique C3- C4, G3: Combined technique G1 and G2, G4: control group.The evaluation technique is spirometry.The intervention protocol is as follows, first the pre-intervention spirometry is performed, then the corresponding technique (according to intervention group), then the post-intervention spirometry, the intervention technique and at 5 minutes, the intervention technique is performed.
Read the detailed description
The objectives of the study are the following: 1. To evaluate the changes in the values of the simple spirometry after the application of the study techniques: muscle stretching technique of the diaphragm (G1), rotation impulse technique of the cervical level of C3- C4 (G2) and combined technique of both (G3); 2. Determine the influence of these on measurable respiratory parameters by simple spirometry; 3. Compare the spirometric values obtained after applying the study techniques (G1, G2, G3) and the control group (G4: simulation of a previous technique); and 4. Analyze the different variables measured (age, gender, weight, height, sports practice and body mass index) in the effects of the applied treatment.
- Conditions
- Respiratory Disease
- Being tested
- Stretching the diaphragm muscle, Impulse technique in rotation of cervical level 3 and 4, Combined technique of diaphragm muscle stretch and cervical rotation impulse technique level 3 and 4
- Keywords
- Diaphragm, Neck, Frenic Nerve
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching the diaphragm muscleProcedure or surgery
Place the hands on the last costal cartilages and maintain the ascent of the ribs in the expiration.
Impulse technique in rotation of cervical level 3 and 4Procedure or surgery
head to double chin position and then placed with neutral flexo-extension until focusing on the level of manipulation, ipsilateral lateral flexion and contralateral rotation approximately 45 degrees.
Combined technique of diaphragm muscle stretch and cervical rotation impulse technique level 3 and 4Procedure or surgery
The same initial position, hand placement and technique guidelines will be used, cited in each of the techniques performed in the "intervention 1" group and the "intervention 2" group.
| Study group | Role | What they receive |
|---|---|---|
| Stretching the diaphragm muscle | Experimental | The interventor places his hands on the last costal cartilages and the subject makes an inspiration and keeps his hands resisted in the expiration. Receives: Procedure: Stretching the diaphragm muscle |
| Impulse technique in rotation of cervical level 3 and 4 | Experimental | The thumbs position the head in a double chin and then place it with neutral flexion-extension until focusing on the level of manipulation, ipsilateral lateral flexion and contralateral rotation approximately 45 degrees. Receives: Procedure: Impulse technique in rotation of cervical level 3 and 4 |
| Combined technique of diaphragm muscle stretch and cervical ro | Experimental | combine both previous techniques. Receives: Procedure: Combined technique of diaphragm muscle stretch and cervical rotation impulse technique level 3 and 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
forced vital capacity
volume of air that we can exhale (quickly, sustainably and maximally) after a maximum expiration from the position of maximum inspiration. It is measured in liters (L).
Measured: a week
Secondary outcomes (1)
Forced expiratory volume in the first second
Maximum expiratory volume in the first second. Volume obtained in the first second of the forced vital capacity maneuver.
Measured: a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start5 Nov 2018
- Primary completion6 Nov 2018
- Study completion18 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERGIO MONTERO NAVARRO, Cardenal Herrera University
- Investigators
- Rocha Ortiz, Principal investigator, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732222
- Sponsor's protocol ID
- UCH CEU 208
- Status last verified
- Nov 2018
- First submitted
- 3 Nov 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kendall FP, Mac Creary EK, Provance PG. Muscles: functional tests, posture and pain. 5th ed. Madrid: Marbán; 2007 Souchard PE. RPG Principles of global postural reeducation. 1st ed. Barcelona: Paidotribo; 2005 American Thoracic Society / European Respiratory Society. ATS / ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002; 166: 518-624.
Rocha-Ortiz MI, Sanchez-Mas J, Del Rio-Medina S, Montero-Navarro S, Perez-Gracia MT, Morera-Balaguer J. Effects of Manual Therapy on Respiratory Function in Healthy Individuals: A Randomized, Sham-Controlled Clinical Trial of Efficacy and Safety. Healthcare (Basel). 2026 Jul 8;14(14):2051. doi: 10.3390/healthcare14142051.
PubMed 42512567
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis, Evaluation and Comparison of Spirometric Values After the Application of the Diaphragm Muscle Stretch Technique and the Cervical Level Rotation Impulse Technique of C3-C4
- ClinicalTrials.gov ID
- NCT03732222
- Acronym / sponsor ID
- UCH CEU 208
- Conditions
- Respiratory Disease
- Keywords
- Diaphragm, Neck, Frenic Nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 6 Nov 2018 (actual)
- Study completion
- 18 Nov 2018 (actual)
- First posted
- 6 Nov 2018 (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.
This study investigates the effect of two different techniques, stretching of the diaphragm and cervical level impulse technique C3-C4, in the possible spirometric changes, vital capacity (CV), maximum expiratory flow (PEF) and maximum expiratory volume (FEV). in relation to the secondary variables (age, physical activity, BMI, sex). the subjects of the study were informed and clarified doubts about it and its subsequent reading and signing of informed consent. The subjects were randomly selected to determine which intervention group they would belong to (G1: intervention group of the diaphragm muscle stretch technique, G2: intervention group of the cervical rotation rotation impulse technique C3- C4, G3: Combined technique G1 and G2, G4: control group.The evaluation technique is spirometry.The intervention protocol is as follows, first the pre-intervention spirometry is performed, then the corresponding technique (according to intervention group), then the post-intervention spirometry, the intervention technique and at 5 minutes, the intervention technique is performed.
Detailed description
The objectives of the study are the following: 1. To evaluate the changes in the values of the simple spirometry after the application of the study techniques: muscle stretching technique of the diaphragm (G1), rotation impulse technique of the cervical level of C3- C4 (G2) and combined technique of both (G3); 2. Determine the influence of these on measurable respiratory parameters by simple spirometry; 3. Compare the spirometric values obtained after applying the study techniques (G1, G2, G3) and the control group (G4: simulation of a previous technique); and 4. Analyze the different variables measured (age, gender, weight, height, sports practice and body mass index) in the effects of the applied treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stretching the diaphragm muscle | Experimental | Procedure: Stretching the diaphragm muscleThe interventor places his hands on the last costal cartilages and the subject makes an inspiration and keeps his hands resisted in the expiration. |
| Impulse technique in rotation of cervical level 3 and 4 | Experimental | Procedure: Impulse technique in rotation of cervical level 3 and 4The thumbs position the head in a double chin and then place it with neutral flexion-extension until focusing on the level of manipulation, ipsilateral lateral flexion and contralateral rotation approximately 45 degrees. |
| Combined technique of diaphragm muscle stretch and cervical ro | Experimental | Procedure: Combined technique of diaphragm muscle stretch and cervical rotation impulse technique level 3 and 4combine both previous techniques. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Accept participating in the study (signature of informed consent).
- Be in an age range between 18 and 50 years.
- Do not present any exclusion criteria.
Key exclusion criteria (12 listed)
- Do not meet the inclusion criteria.
- Have obstructive and / or restrictive respiratory problems.
- Perfect transient conditions that affect the respiratory tract, such as colds, sinusitis, influenza, respiratory allergies.
- To have a history of rib fractures.
- Congenital deformities.
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 |
|---|---|---|
| Stretching the diaphragm musclePlace the hands on the last costal cartilages and maintain the ascent of the ribs in the expiration. | Procedure or surgery | Stretching the diaphragm muscle |
| Impulse technique in rotation of cervical level 3 and 4head to double chin position and then placed with neutral flexo-extension until focusing on the level of manipulation, ipsilateral lateral flexion and contralateral rotation approximately 45 degrees. | Procedure or surgery | Impulse technique in rotation of cervical level 3 and 4 |
| Combined technique of diaphragm muscle stretch and cervical rotation impulse technique level 3 and 4The same initial position, hand placement and technique guidelines will be used, cited in each of the techniques performed in the "intervention 1" group and the "intervention 2" group. | Procedure or surgery | Combined technique of diaphragm muscle stretch and cervical ro |
Primary outcome
forced vital capacity
Time frame: a week
volume of air that we can exhale (quickly, sustainably and maximally) after a maximum expiration from the position of maximum inspiration. It is measured in liters (L).
1 secondary outcome
Forced expiratory volume in the first second
Time frame: a week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- BackgroundKendall FP, Mac Creary EK, Provance PG. Muscles: functional tests, posture and pain. 5th ed. Madrid: Marbán; 2007 Souchard PE. RPG Principles of global postural reeducation. 1st ed. Barcelona: Paidotribo; 2005 American Thoracic Society / European Respiratory Society. ATS / ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002; 166: 518-624.
- Derived from this study: PubMed 42512567Rocha-Ortiz MI, Sanchez-Mas J, Del Rio-Medina S, Montero-Navarro S, Perez-Gracia MT, Morera-Balaguer J. Effects of Manual Therapy on Respiratory Function in Healthy Individuals: A Randomized, Sham-Controlled Clinical Trial of Efficacy and Safety. Healthcare (Basel). 2026 Jul 8;14(14):2051. doi: 10.3390/healthcare14142051.
- The University CEU-Cardenal Herrera is the first private university in the Valencian Community. It belongs to the Foundation San Pablo- CEU and is the leading educational organization in Spain with three Universities all over SpainLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Rocha Ortiz principal investigator
Cardenal Herrera University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching the diaphragm muscle, Impulse technique in rotation of cervical level 3 and 4 and Combined technique of diaphragm muscle stretch and cervical rotation impulse technique level 3 and 4 in people with Respiratory Disease, run by Cardenal Herrera University at 1 site in Spain.
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 3 inclusion and 12 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: finished, as of the sponsor's last update on 20 Nov 2018. 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 Spain. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
forced vital capacity (time frame: a week). 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 NCT03732222, which also lists 2 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 20 Nov 2018.