HealthyNCT04399993
Effect of Osteopathic Manual Techniques on the Diaphragm Muscle and Its Repercussions
A study testing Intervention Protocol in Diaphragm in people with Healthy, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
Trial summary
Determining the effects of an intervention plan on the diaphragm related to the center of gravity and range of motion in the lumbar spine (static and dynamic) in healthy individuals is an area that lacks evidence and proper studies. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Intervention Protocol in Diaphragm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages between 18 and 30 years old;
- Both genders;
Who cannot join
- Treatments with manual therapy in the last three months or more than three times in the previous year;
- Lumbar spine pathology (infection, spinal fracture or more severe neurological impairment, such as cauda equina syndrome) and respiratory pathologies;
- Psychiatric illness;
- Recent history of trauma;
- History of cancer;
- Systemic inflammatory conditions;
Show all 10Show fewer
- Recent history of spinal surgery;
- Abdominal pain at the time of the intervention;
- Body mass index (BMI) equal to or greater than 31kg / m2, due to the difficulty in accessing the diaphragm;
- All of those that acquired a higher knowledge within the area of manual therapy, which may compromise its validation.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Escola Superior de Saúde do Politécnico do Porto
Porto, 4200-072
Natália MO Campelo, PhD, +351938674365, ncampelo.estsp.ipp@gmail.com
About this study
Official title: Effect of Osteopathic Manual Techniques on the Diaphragm Muscle and Its Repercussions in Healthy Young Adults
Determining the effects of an intervention plan on the diaphragm related to the center of gravity and range of motion in the lumbar spine (static and dynamic) in healthy individuals is an area that lacks evidence and proper studies. Has such, the investigators consider this a interesting topic to study, therefore it is intended to improve the knowledge on this area.
Read the detailed description
All diaphragmatic activity is controlled by metabolic mechanisms and emotional states which may cause restrictions that might be related to disorders in the lower back.
The diaphragm and the lumbar segment of the spine are connected through the diaphgramathic pillars that connect the central tendon and the vertebrae of L2 (left side) and L3/L4 (right side). Consequently, the contraction of the pillars may be related to the fixation of the lumbar spine.
Proper function of the diaphragm is related to better parameters of static balance. It is also possible to conclude that a change in the proper function of the diaphragm is associated with changes in the center of gravity in healthy individuals.
This theme lacks scientific evidence, since no studies were found that focus on the analysis of diaphragmatic treatment only. In this way, the investigators intend to collaborate to increase knowledge in this area, determining the effects of the intervention plan on the diaphragm in relation to the range of motion and center of gravity in the lumbar spine (static and dynamic) in healthy individuals.
- Conditions
- Healthy
- Being tested
- Intervention Protocol in Diaphragm, Sham technique
- Keywords
- Osteopathy, Diaphragm, Center of Pressure, Range of Motion, Thoracolumbar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Protocol in DiaphragmOther
The protocol consists of three techniques. The two first techniques will be applied for 10 respiratory cycles.
Muscle Stretching Technique:
the researcher will perform a cephalic traction on the inferior costal border with the ulnar border during the inspiratory phase.
Phrenic-center inhibition technique:
the researcher, with a hand on the sternum to caudal and other hand on the umbilical region to cranial, will approach his hands on the horizontal plane, when the volunteer exales.
Functional diaphragm technique:
the researcher will perform a vertical pressure on the diaphragm for 5 minutes and will search for the facilitated parameters and maintain them until the release of all the periarticular elements.
Sham techniqueOther
In the sham group a manual contact without any therapeutic intention will be performed, in a distant region of the diaphragm (for example on the trapezius muscle). This contact will be maintained during the same amount of time as for the treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Protocol in Diaphragm | Experimental | In each volunteer, after a brief questionnaire, it will be measured the center of gravity and the range of movement of the lumbar spine before the technique.
Each volunteer will stay in supine position with arms along their body, in which their legs may be either extended or flexed.
Next, the researcher will perform the intervention protocol in Diaphragm. Then, all the measurements described before, will be repeated by the assessor right after the technique. Receives: Other: Intervention Protocol in Diaphragm |
| Sham Technique | Sham comparator | In each volunteer, after a brief questionnaire, it will be measured the center of gravity and the range of movement of the lumbar spine before the technique.
Each volunteer will stay in supine position with arms along their body, in which their legs may be either extended or flexed.
Next, the researcher will perform the Sham technique. Then, all the measurements described before, will be repeated by the assessor right after the technique. Receives: Other: Sham technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of Center of gravity immediately after the intervention
To obtain the center of gravity measurements, it will be used the system Qualisys Track Manager. First, it will be placed in the subject spheric markers on the spinous processes of T12, L3 and S2 and both anterior and posterior superior iliac spines.
The cameras will be arranged to cover the area to the test, which it will be performed in a hard surface with the help of reflector-markers that will evaluate the movements.
The data will be collected twice, with the eyes open and closed. They'll be standing in the platform for 90 seconds each time and the data will be collected at the 30, 60 and 90 seconds.
The software is going to be used to convert the data in coordinates in the x, y and z axis, which it will allow to analyse the tridimensional kinematics of the lumbar spine Through the intrinsical board of Qualysis Track Manager it will be evaluated the relation of the center of pressure with the vertical projection of the center of mass through the distance between both.
Measured: Immediately after the intervention
Secondary outcomes (1)
Change from Baseline in Range of Movement of the lumbar spine immediately after the intervention
To obtain the center of gravity measurements, it will be used the system Qualisys Track Manager. First, it will be placed in the subject spheric markers on the spinous processes of T12, L3 and S2 and both anterior and posterior superior iliac spines.
The cameras will be arranged to cover the area to the test, which it will be performed in a hard surface with the help of reflector-markers that will evaluate the movements.
The data will be collected by asking the volunteer to perform certain movements such as anterior and lateral flexion.
The software is going to be used to convert the data in coordinates in the x, y and z axis, which it will allow to analyse the tridimensional kinematics of the lumbar spine Through the intrinsical board of Qualysis Track Manager it will be evaluated the relation of the center of pressure with the vertical projection of the center of mass through the distance between both.
Measured: Immediately 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 posted22 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 (18)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
- 60 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 Saúde do Politécnico do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399993
- Sponsor's protocol ID
- OST1- 001
- Status last verified
- Apr 2024
- First submitted
- 19 May 2020
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Licciardone JC, Kearns CM, Minotti DE. Outcomes of osteopathic manual treatment for chronic low back pain according to baseline pain severity: results from the OSTEOPATHIC Trial. Man Ther. 2013 Dec;18(6):533-40. doi: 10.1016/j.math.2013.05.006. Epub 2013 Jun 10.
PubMed 23759340Acute low back problems in adults: assessment and treatment. Agency for Health Care Policy and Research. Clin Pract Guidel Quick Ref Guide Clin. 1994 Dec;(14):iii-iv, 1-25.
PubMed 7987418Nason LK, Walker CM, McNeeley MF, Burivong W, Fligner CL, Godwin JD. Imaging of the diaphragm: anatomy and function. Radiographics. 2012 Mar-Apr;32(2):E51-70. doi: 10.1148/rg.322115127.
PubMed 22411950Grams ST, von Saltiel R, Mayer AF, Schivinski CI, de S Nobre LF, Nobrega IS, Jacomino ME, Paulin E. Assessment of the reproducibility of the indirect ultrasound method of measuring diaphragm mobility. Clin Physiol Funct Imaging. 2014 Jan;34(1):18-25. doi: 10.1111/cpf.12058. Epub 2013 Jun 4.
PubMed 23730805van Tulder M, Becker A, Bekkering T, Breen A, del Real MT, Hutchinson A, Koes B, Laerum E, Malmivaara A; COST B13 Working Group on Guidelines for the Management of Acute Low Back Pain in Primary Care. Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S169-91. doi: 10.1007/s00586-006-1071-2. No abstract available.
PubMed 16550447Marti-Salvador M, Hidalgo-Moreno L, Domenech-Fernandez J, Lison JF, Arguisuelas MD. Osteopathic Manipulative Treatment Including Specific Diaphragm Techniques Improves Pain and Disability in Chronic Nonspecific Low Back Pain: A Randomized Trial. Arch Phys Med Rehabil. 2018 Sep;99(9):1720-1729. doi: 10.1016/j.apmr.2018.04.022. Epub 2018 May 19.
PubMed 29787734Savigny P, Watson P, Underwood M; Guideline Development Group. Early management of persistent non-specific low back pain: summary of NICE guidance. BMJ. 2009 Jun 4;338:b1805. doi: 10.1136/bmj.b1805. No abstract available.
PubMed 19502217Rubinstein SM, van Middelkoop M, Assendelft WJ, de Boer MR, van Tulder MW. Spinal manipulative therapy for chronic low-back pain: an update of a Cochrane review. Spine (Phila Pa 1976). 2011 Jun;36(13):E825-46. doi: 10.1097/BRS.0b013e3182197fe1.
PubMed 21593658Hagg O, Fritzell P, Nordwall A; Swedish Lumbar Spine Study Group. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J. 2003 Feb;12(1):12-20. doi: 10.1007/s00586-002-0464-0. Epub 2002 Oct 24.
PubMed 12592542Bagheri R, Ebrahimi Takamjani I, Dadgoo M, Ahmadi A, Sarrafzadeh J, Pourahmadi MR, Jafarpisheh AS. Gender-Related Differences in Reliability of Thorax, Lumbar, and Pelvis Kinematics During Gait in Patients With Non-specific Chronic Low Back Pain. Ann Rehabil Med. 2018 Apr;42(2):239-249. doi: 10.5535/arm.2018.42.2.239. Epub 2018 Apr 30.
PubMed 29765877Shahbazi Moheb Seraj M, Sarrafzadeh J, Maroufi N, Ebrahimi Takamjani I, Ahmadi A, Negahban H. The Ratio of Lumbar to Hip Motion during the Trunk Flexion in Patients with Mechanical Chronic Low Back Pain According to O'Sullivan Classification System: A Cross-sectional Study. Arch Bone Jt Surg. 2018 Nov;6(6):560-569.
PubMed 30637313Wu G, Siegler S, Allard P, Kirtley C, Leardini A, Rosenbaum D, Whittle M, D'Lima DD, Cristofolini L, Witte H, Schmid O, Stokes I; Standardization and Terminology Committee of the International Society of Biomechanics. ISB recommendation on definitions of joint coordinate system of various joints for the reporting of human joint motion--part I: ankle, hip, and spine. International Society of Biomechanics. J Biomech. 2002 Apr;35(4):543-8. doi: 10.1016/s0021-9290(01)00222-6.
PubMed 11934426Masani K, Vette AH, Kouzaki M, Kanehisa H, Fukunaga T, Popovic MR. Larger center of pressure minus center of gravity in the elderly induces larger body acceleration during quiet standing. Neurosci Lett. 2007 Jul 18;422(3):202-6. doi: 10.1016/j.neulet.2007.06.019. Epub 2007 Jun 17.
PubMed 17611029Doyle RJ, Hsiao-Wecksler ET, Ragan BG, Rosengren KS. Generalizability of center of pressure measures of quiet standing. Gait Posture. 2007 Feb;25(2):166-71. doi: 10.1016/j.gaitpost.2006.03.004. Epub 2006 Apr 19.
PubMed 16624560Qualisys, A. B., & Gothenburg, S. (2011). Qualisys track manager. New York: User Manual.
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
- Effect of Osteopathic Manual Techniques on the Diaphragm Muscle and Its Repercussions in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT04399993
- Acronym / sponsor ID
- OST1- 001
- Conditions
- Healthy
- Keywords
- Osteopathy, Diaphragm, Center of Pressure, Range of Motion, Thoracolumbar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 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
- 22 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.
Determining the effects of an intervention plan on the diaphragm related to the center of gravity and range of motion in the lumbar spine (static and dynamic) in healthy individuals is an area that lacks evidence and proper studies. Has such, the investigators consider this a interesting topic to study, therefore it is intended to improve the knowledge on this area.
Detailed description
All diaphragmatic activity is controlled by metabolic mechanisms and emotional states which may cause restrictions that might be related to disorders in the lower back.
The diaphragm and the lumbar segment of the spine are connected through the diaphgramathic pillars that connect the central tendon and the vertebrae of L2 (left side) and L3/L4 (right side). Consequently, the contraction of the pillars may be related to the fixation of the lumbar spine.
Proper function of the diaphragm is related to better parameters of static balance. It is also possible to conclude that a change in the proper function of the diaphragm is associated with changes in the center of gravity in healthy individuals.
This theme lacks scientific evidence, since no studies were found that focus on the analysis of diaphragmatic treatment only. In this way, the investigators intend to collaborate to increase knowledge in this area, determining the effects of the intervention plan on the diaphragm in relation to the range of motion and center of gravity in the lumbar spine (static and dynamic) in healthy individuals.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Protocol in Diaphragm | Experimental | Other: Intervention Protocol in DiaphragmIn each volunteer, after a brief questionnaire, it will be measured the center of gravity and the range of movement of the lumbar spine before the technique. Each volunteer will stay in supine position with arms along their body, in which their legs may be either extended or flexed. Next, the researcher will perform the intervention protocol in Diaphragm. Then, all the measurements described before, will be repeated by the assessor right after the technique. |
| Sham Technique | Sham comparator | Other: Sham techniqueIn each volunteer, after a brief questionnaire, it will be measured the center of gravity and the range of movement of the lumbar spine before the technique. Each volunteer will stay in supine position with arms along their body, in which their legs may be either extended or flexed. Next, the researcher will perform the Sham technique. Then, all the measurements described before, will be repeated by the assessor right after the technique. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ages between 18 and 30 years old;
- Both genders;
Key exclusion criteria (10 listed)
- Treatments with manual therapy in the last three months or more than three times in the previous year;
- Lumbar spine pathology (infection, spinal fracture or more severe neurological impairment, such as cauda equina syndrome) and respiratory pathologies;
- Psychiatric illness;
- Recent history of trauma;
- History of cancer;
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 |
|---|---|---|
| Intervention Protocol in DiaphragmThe protocol consists of three techniques. The two first techniques will be applied for 10 respiratory cycles. Muscle Stretching Technique: the researcher will perform a cephalic traction on the inferior costal border with the ulnar border during the inspiratory phase. Phrenic-center inhibition technique: the researcher, with a hand on the sternum to caudal and other hand on the umbilical region to cranial, will approach his hands on the horizontal plane, when the volunteer exales. Functional diaphragm technique: the researcher will perform a vertical pressure on the diaphragm for 5 minutes and will search for the facilitated parameters and maintain them until the release of all the periarticular elements. | Other | Intervention Protocol in Diaphragm |
| Sham techniqueIn the sham group a manual contact without any therapeutic intention will be performed, in a distant region of the diaphragm (for example on the trapezius muscle). This contact will be maintained during the same amount of time as for the treatment group. | Other | Sham Technique |
Primary outcome
Change from Baseline of Center of gravity immediately after the intervention
Time frame: Immediately after the intervention
To obtain the center of gravity measurements, it will be used the system Qualisys Track Manager. First, it will be placed in the subject spheric markers on the spinous processes of T12, L3 and S2 and both anterior and posterior superior iliac spines. The cameras will be arranged to cover the area to the test, which it will be performed in a hard surface with the help of reflector-markers that will evaluate the movements. The data will be collected twice, with the eyes open and closed. They'll be standing in the platform for 90 seconds each time and the data will be collected at the 30, 60 and 90 seconds. The software is going to be used to convert the data in coordinates in the x, y and z axis, which it will allow to analyse the tridimensional kinematics of the lumbar spine Through the intrinsical board of Qualysis Track Manager it will be evaluated the relation of the center of pressure with the vertical projection of the center of mass through the distance between both.
1 secondary outcome
Change from Baseline in Range of Movement of the lumbar spine immediately after the intervention
Time frame: Immediately 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 23759340Licciardone JC, Kearns CM, Minotti DE. Outcomes of osteopathic manual treatment for chronic low back pain according to baseline pain severity: results from the OSTEOPATHIC Trial. Man Ther. 2013 Dec;18(6):533-40. doi: 10.1016/j.math.2013.05.006. Epub 2013 Jun 10.
- Background: PubMed 7987418Acute low back problems in adults: assessment and treatment. Agency for Health Care Policy and Research. Clin Pract Guidel Quick Ref Guide Clin. 1994 Dec;(14):iii-iv, 1-25.
- Background: PubMed 22411950Nason LK, Walker CM, McNeeley MF, Burivong W, Fligner CL, Godwin JD. Imaging of the diaphragm: anatomy and function. Radiographics. 2012 Mar-Apr;32(2):E51-70. doi: 10.1148/rg.322115127.
- Background: PubMed 23730805Grams ST, von Saltiel R, Mayer AF, Schivinski CI, de S Nobre LF, Nobrega IS, Jacomino ME, Paulin E. Assessment of the reproducibility of the indirect ultrasound method of measuring diaphragm mobility. Clin Physiol Funct Imaging. 2014 Jan;34(1):18-25. doi: 10.1111/cpf.12058. Epub 2013 Jun 4.
- Background: PubMed 16550447van Tulder M, Becker A, Bekkering T, Breen A, del Real MT, Hutchinson A, Koes B, Laerum E, Malmivaara A; COST B13 Working Group on Guidelines for the Management of Acute Low Back Pain in Primary Care. Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S169-91. doi: 10.1007/s00586-006-1071-2. No abstract available.
- Background: PubMed 29787734Marti-Salvador M, Hidalgo-Moreno L, Domenech-Fernandez J, Lison JF, Arguisuelas MD. Osteopathic Manipulative Treatment Including Specific Diaphragm Techniques Improves Pain and Disability in Chronic Nonspecific Low Back Pain: A Randomized Trial. Arch Phys Med Rehabil. 2018 Sep;99(9):1720-1729. doi: 10.1016/j.apmr.2018.04.022. Epub 2018 May 19.
- Background: PubMed 19502217Savigny P, Watson P, Underwood M; Guideline Development Group. Early management of persistent non-specific low back pain: summary of NICE guidance. BMJ. 2009 Jun 4;338:b1805. doi: 10.1136/bmj.b1805. No abstract available.
- Background: PubMed 21593658Rubinstein SM, van Middelkoop M, Assendelft WJ, de Boer MR, van Tulder MW. Spinal manipulative therapy for chronic low-back pain: an update of a Cochrane review. Spine (Phila Pa 1976). 2011 Jun;36(13):E825-46. doi: 10.1097/BRS.0b013e3182197fe1.
- Background: PubMed 12592542Hagg O, Fritzell P, Nordwall A; Swedish Lumbar Spine Study Group. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J. 2003 Feb;12(1):12-20. doi: 10.1007/s00586-002-0464-0. Epub 2002 Oct 24.
- Background: PubMed 29765877Bagheri R, Ebrahimi Takamjani I, Dadgoo M, Ahmadi A, Sarrafzadeh J, Pourahmadi MR, Jafarpisheh AS. Gender-Related Differences in Reliability of Thorax, Lumbar, and Pelvis Kinematics During Gait in Patients With Non-specific Chronic Low Back Pain. Ann Rehabil Med. 2018 Apr;42(2):239-249. doi: 10.5535/arm.2018.42.2.239. Epub 2018 Apr 30.
- Background: PubMed 30637313Shahbazi Moheb Seraj M, Sarrafzadeh J, Maroufi N, Ebrahimi Takamjani I, Ahmadi A, Negahban H. The Ratio of Lumbar to Hip Motion during the Trunk Flexion in Patients with Mechanical Chronic Low Back Pain According to O'Sullivan Classification System: A Cross-sectional Study. Arch Bone Jt Surg. 2018 Nov;6(6):560-569.
- Background: PubMed 11934426Wu G, Siegler S, Allard P, Kirtley C, Leardini A, Rosenbaum D, Whittle M, D'Lima DD, Cristofolini L, Witte H, Schmid O, Stokes I; Standardization and Terminology Committee of the International Society of Biomechanics. ISB recommendation on definitions of joint coordinate system of various joints for the reporting of human joint motion--part I: ankle, hip, and spine. International Society of Biomechanics. J Biomech. 2002 Apr;35(4):543-8. doi: 10.1016/s0021-9290(01)00222-6.
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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 Saúde do Politécnico 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 Intervention Protocol in Diaphragm 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 2 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 (+351 938674365, 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 of Center of gravity immediately after the intervention (time frame: Immediately after the intervention). 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 NCT04399993, which also lists 18 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.