Shoulder PainNCT05748522
Functional Movement Analysis (FMS) of Diaphragmatic Breathing-Immediate Effect on Shoulder Mobility
A study testing Shoulder Mobility and Diaphragmatic Breathing in people with Shoulder Pain and Diaphragm Issues, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The diaphragm is defined as a thin, smooth muscle that separates the thoracic and abdominal cavities. The shoulder and diaphragm muscle have a clear relationship through innervation and myofascial tissue connection. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain, Diaphragm Issues
- What is being tested?
- Shoulder Mobility and Diaphragmatic Breathing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Oct 2022to 20 Dec 2022
- 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
- Volunteer to participate in the study
- Individuals between the ages of 18-30
Who cannot join
- Have a musculoskeletal injury/operation involving the shoulder area in the last 6 months
- Using drugs that can affect the respiratory system
- Have received aerobic exercise training in the last 6 weeks
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Ankara, Etlik, 06010
About this study
Official title: Functional Movement Analysis (FMS) of Diaphragmatic Breathing-Immediate Effect on Shoulder Mobility- Randomized Controlled, Single-Blind Study
The diaphragm is defined as a thin, smooth muscle that separates the thoracic and abdominal cavities. The shoulder and diaphragm muscle have a clear relationship through innervation and myofascial tissue connection. Fascia is often neglected medically, rehabilitatively, or performance as the underlying cause of problems. Bones, organs, and muscles appear to float in the fascial web, a continuous three-dimensional system of connective tissue. Plastic and viscoelastic properties, which can change tension and shape under the influence of manual techniques and movement retraining, ensure that the structural changes are reversible. Functional Movement Analysis (FMS) is a screening system that aims to predict the risk of injury and functional deficiencies. FMS consists of 7 basic motion component tests. It is scored on a scale of zero to three and creates a composite score whose sum ranges from 0 to 21 points. One of the 7 motion models evaluated is shoulder mobility. According to the results of this study, people who perform activities that require shoulder mobility will be guided as to whether the use of diaphragmatic breathing will be effective for preparation, rehabilitation or performance improvement. The aim of the study was to observe whether shoulder mobility increased in healthy individuals taught diaphragm breathing compared to the control group.
- Conditions
- Shoulder Pain, Diaphragm Issues
- Being tested
- Shoulder Mobility, Diaphragmatic Breathing
- Keywords
- Diaphragmatic Breathing, Functional Movement Analysis (FMS), Shoulder Mobility
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder MobilityOther
t is one of the seven functional movements studied in FMS. This test requires the participant to simultaneously hold one hand behind the back (internal rotation) and the other hand behind the head (external rotation) with the fisted hands, and bring the hands as close to each other as possible in the back area. The distance measurement in cm is taken with a tape measure between 3 fingers of both hands.
Diaphragmatic BreathingProcedure or surgery
The participant will lie on his back in a comfortable position, diaphragmatic breathing will be taught first in the application group and he will be asked to do diaphragmatic breathing for 90 seconds. At the end of this period, the participant will be referred back to the evaluator physiotherapist, and the physiotherapist will evaluate the shoulder mobility again without knowing which group the participant is in.
In the participant control group, shoulder mobility will be evaluated and the practitioner will be asked to stay in a comfortable position on his back for 90 seconds next to the physiotherapist. At the end of the period, shoulder mobility will be evaluated again by the assessing physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Shoulder Mobility | Other | It is one of the seven functional movements studied in FMS. This test requires the participant to simultaneously hold one hand behind the back (internal rotation) and the other hand behind the head (external rotation) with the fisted hands, and bring the hands as close to each other as possible in the back area. The distance measurement in cm is taken with a tape measure between 3 fingers of both hands. This type of reach test has been described as a tool for measuring glenohumeral joint (GH) mobility through functional shoulder movements. Receives: Procedure: Diaphragmatic Breathing |
| Diaphragmatic Breathing | Experimental | The participant lies on his back. He places his hands horizontally on the lowest part of the ribs. While inhaling, he is asked to inflate his stomach towards the bottom of his hands. It is taught that during breathing, the abdomen should swell rather than the rib cage, and the ribs should open outwards. Breath is taken through the nose, blown slowly through the mouth. Receives: Other: Shoulder Mobility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Mobility Measurement
It is one of the seven functional movements studied in FMS. This test requires the participant to simultaneously hold one hand behind the back (internal rotation) and the other hand behind the head (external rotation) with the fisted hands, and bring the hands as close to each other as possible in the back area. The distance measurement in cm is taken with a tape measure between 3 fingers of both hands.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start12 Oct 2022
- Primary completion22 Nov 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748522
- Sponsor's protocol ID
- 2022-240
- Status last verified
- Sep 2023
- First submitted
- 20 Feb 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Movement Analysis (FMS) of Diaphragmatic Breathing-Immediate Effect on Shoulder Mobility- Randomized Controlled, Single-Blind Study
- ClinicalTrials.gov ID
- NCT05748522
- Acronym / sponsor ID
- 2022-240
- Conditions
- Shoulder Pain, Diaphragm Issues
- Keywords
- Diaphragmatic Breathing, Functional Movement Analysis (FMS), Shoulder Mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 28 Feb 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.
The diaphragm is defined as a thin, smooth muscle that separates the thoracic and abdominal cavities. The shoulder and diaphragm muscle have a clear relationship through innervation and myofascial tissue connection. Fascia is often neglected medically, rehabilitatively, or performance as the underlying cause of problems. Bones, organs, and muscles appear to float in the fascial web, a continuous three-dimensional system of connective tissue. Plastic and viscoelastic properties, which can change tension and shape under the influence of manual techniques and movement retraining, ensure that the structural changes are reversible. Functional Movement Analysis (FMS) is a screening system that aims to predict the risk of injury and functional deficiencies. FMS consists of 7 basic motion component tests. It is scored on a scale of zero to three and creates a composite score whose sum ranges from 0 to 21 points. One of the 7 motion models evaluated is shoulder mobility. According to the results of this study, people who perform activities that require shoulder mobility will be guided as to whether the use of diaphragmatic breathing will be effective for preparation, rehabilitation or performance improvement. The aim of the study was to observe whether shoulder mobility increased in healthy individuals taught diaphragm breathing compared to the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shoulder Mobility | Other | Procedure: Diaphragmatic BreathingIt is one of the seven functional movements studied in FMS. This test requires the participant to simultaneously hold one hand behind the back (internal rotation) and the other hand behind the head (external rotation) with the fisted hands, and bring the hands as close to each other as possible in the back area. The distance measurement in cm is taken with a tape measure between 3 fingers of both hands. This type of reach test has been described as a tool for measuring glenohumeral joint (GH) mobility through functional shoulder movements. |
| Diaphragmatic Breathing | Experimental | Other: Shoulder MobilityThe participant lies on his back. He places his hands horizontally on the lowest part of the ribs. While inhaling, he is asked to inflate his stomach towards the bottom of his hands. It is taught that during breathing, the abdomen should swell rather than the rib cage, and the ribs should open outwards. Breath is taken through the nose, blown slowly through the mouth. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Volunteer to participate in the study
- Individuals between the ages of 18-30
Key exclusion criteria (3 listed)
- Have a musculoskeletal injury/operation involving the shoulder area in the last 6 months
- Using drugs that can affect the respiratory system
- Have received aerobic exercise training in the last 6 weeks
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 |
|---|---|---|
| Shoulder Mobilityt is one of the seven functional movements studied in FMS. This test requires the participant to simultaneously hold one hand behind the back (internal rotation) and the other hand behind the head (external rotation) with the fisted hands, and bring the hands as close to each other as possible in the back area. The distance measurement in cm is taken with a tape measure between 3 fingers of both hands. | Other | Diaphragmatic Breathing |
| Diaphragmatic BreathingThe participant will lie on his back in a comfortable position, diaphragmatic breathing will be taught first in the application group and he will be asked to do diaphragmatic breathing for 90 seconds. At the end of this period, the participant will be referred back to the evaluator physiotherapist, and the physiotherapist will evaluate the shoulder mobility again without knowing which group the participant is in. In the participant control group, shoulder mobility will be evaluated and the practitioner will be asked to stay in a comfortable position on his back for 90 seconds next to the physiotherapist. At the end of the period, shoulder mobility will be evaluated again by the assessing physiotherapist. | Procedure or surgery | Shoulder Mobility |
Primary outcome
Shoulder Mobility Measurement
Time frame: 4 weeks
It is one of the seven functional movements studied in FMS. This test requires the participant to simultaneously hold one hand behind the back (internal rotation) and the other hand behind the head (external rotation) with the fisted hands, and bring the hands as close to each other as possible in the back area. The distance measurement in cm is taken with a tape measure between 3 fingers of both hands.
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 21 Sep 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder Mobility and Diaphragmatic Breathing in people with Shoulder Pain and Diaphragm Issues, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
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 3 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 21 Sep 2023. 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 Turkey (Türkiye). 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?
Shoulder Mobility Measurement (time frame: 4 weeks). 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 21 Sep 2023.