HealthyNCT05787626
Efficacy of the Transverse Planes Technique in the Diaphragmatic Region in Young Subjects.
A study testing manipulation in people with Healthy and Diaphragm Issues, run by Universidad Católica San Antonio de Murcia.
Trial summary
In the present study, 28 healthy young people will be selected, who will be evaluated by a blind investigator regarding the study objectives, and will be randomly included in two groups. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Diaphragm Issues
- What is being tested?
- manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 30 May 2023
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy people
- no spinal pathology
- no respiratory pathology
Who cannot join
- have suffered spinal pathologies in the last 3 months
- have suffered respiratory diseases in the last 3 months
About this study
Official title: Efficacy of the Transverse Planes Technique in the Diaphragmatic Region in Young Subjects. A Randomized Controlled Trial
In the present study, 28 healthy young people will be selected, who will be evaluated by a blind investigator regarding the study objectives, and will be randomly included in two groups. The experimental group will consist of 14 subjects who will carry out 1 weekly session of 10 minutes and who will be evaluated just before starting the intervention, after it and at 4 weeks. The control group will be made up of 14 subjects who will be evaluated in the three periods described without the need to carry out the intervention.
Read the detailed description
The intervention will be carried out for 4 weeks, with 1 weekly session of 10 minutes duration. The patient will go to the intervention room where the treatment procedure will be explained in detail. He will be explained verbally and with a visual demonstration of what the technique consists of and how it is going to be performed, the position that he has to adopt during and how long the intervention will last.
The intervention consists of the application of a myofascial technique in the diaphragmatic region, one hand of the therapist will be placed on the hemidiaphragm to be treated and the other hand on the same side but on the dorsal part of the patient on the costal edge of the last ribs.
The patient will be asked to focus on their own breathing and the contact that the therapist will apply.
In the subjects of the control group, the hands will be placed in the same position but without any therapeutic intention, applying the minimum possible pressure.
- Conditions
- Healthy, Diaphragm Issues
- Being tested
- manipulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manipulationOther
miofascial technique in diaphragmatic region
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | The intervention consists of the application of a myofascial technique in the diaphragmatic region, one hand of the therapist will be placed on the hemidiaphragm to be treated and the other hand on the same side but on the dorsal part of the patient on the costal edge of the last ribs. Receives: Other: manipulation |
| Control group | Sham comparator | In the subjects of the control group, the hands will be placed in the same position but without any therapeutic intention, applying the minimum possible pressure. Receives: Other: manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Centimetric measurement of the thorax
measuring the difference in circumference after maximum inhalation through the nose and maximum exhalation through the mouth, the measurement is made at the level of the xiphoid process
Measured: change from baseline to one month
Back range of motion
Performing the Ott Test, which consists of performing, with the subject standing, two measurements, one in the lower part of the spinous process of C7 and the other 30 centimeters below the previous mark.
Measured: change from baseline to one month
Inspiratory and expiratory capacity
will be carried out using an incentive spirometer
Measured: change from baseline to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasemin Todri, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787626
- Sponsor's protocol ID
- CE022305
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Transverse Planes Technique in the Diaphragmatic Region in Young Subjects. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05787626
- Acronym / sponsor ID
- CE022305
- Conditions
- Healthy, Diaphragm Issues
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 28 Mar 2023 (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.
In the present study, 28 healthy young people will be selected, who will be evaluated by a blind investigator regarding the study objectives, and will be randomly included in two groups. The experimental group will consist of 14 subjects who will carry out 1 weekly session of 10 minutes and who will be evaluated just before starting the intervention, after it and at 4 weeks. The control group will be made up of 14 subjects who will be evaluated in the three periods described without the need to carry out the intervention.
Detailed description
The intervention will be carried out for 4 weeks, with 1 weekly session of 10 minutes duration. The patient will go to the intervention room where the treatment procedure will be explained in detail. He will be explained verbally and with a visual demonstration of what the technique consists of and how it is going to be performed, the position that he has to adopt during and how long the intervention will last.
The intervention consists of the application of a myofascial technique in the diaphragmatic region, one hand of the therapist will be placed on the hemidiaphragm to be treated and the other hand on the same side but on the dorsal part of the patient on the costal edge of the last ribs.
The patient will be asked to focus on their own breathing and the contact that the therapist will apply.
In the subjects of the control group, the hands will be placed in the same position but without any therapeutic intention, applying the minimum possible pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: manipulationThe intervention consists of the application of a myofascial technique in the diaphragmatic region, one hand of the therapist will be placed on the hemidiaphragm to be treated and the other hand on the same side but on the dorsal part of the patient on the costal edge of the last ribs. |
| Control group | Sham comparator | Other: manipulationIn the subjects of the control group, the hands will be placed in the same position but without any therapeutic intention, applying the minimum possible pressure. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy people
- no spinal pathology
- no respiratory pathology
Key exclusion criteria (2 listed)
- have suffered spinal pathologies in the last 3 months
- have suffered respiratory diseases in the last 3 months
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 |
|---|---|---|
| manipulationmiofascial technique in diaphragmatic region | Other | Control group, Interventional group |
Primary outcome
Centimetric measurement of the thorax
Time frame: change from baseline to one month
measuring the difference in circumference after maximum inhalation through the nose and maximum exhalation through the mouth, the measurement is made at the level of the xiphoid process
Back range of motion
Time frame: change from baseline to one month
Performing the Ott Test, which consists of performing, with the subject standing, two measurements, one in the lower part of the spinous process of C7 and the other 30 centimeters below the previous mark.
Inspiratory and expiratory capacity
Time frame: change from baseline to one month
will be carried out using an incentive spirometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing manipulation in people with Healthy and Diaphragm Issues, run by Universidad Católica San Antonio de Murcia.
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 2 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 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Centimetric measurement of the thorax (time frame: change from baseline to one month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2023.