Shoulder PainSHOULDER-DIAPHNCT07334171
Inspiratory Muscle Strength and Diaphragm Thickness in People With Shoulder Pain in Tennis Players
An observational study of Shoulder Pain, run by Universidad Francisco de Vitoria at 1 site in Spain.
Trial summary
This observational case-control study will compare inspiratory muscle function and diaphragm morphology between individuals with shoulder pain and asymptomatic controls. Participants will be allocated into two groups according to the presence or absence of shoulder pain. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2026to 20 Mar 2026
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adult racket sport players aged 18 to 60 years, both with and without non-specific shoulder pain, recruited from local sports clubs and university-related facilities.
Who may be able to join
- Tennis player who suffered from non-specific shoulder pain
- Training at least two times per week
- Have experienced at least 1 episode of non-specific shoulder pain in the last month
- A positive result on the following diagnostic tests: Neer Test and Jobe Test
Who cannot join
- Having taken anti-inflammatories or muscle relaxants within the last 72 hours before the study
- Pregnancy
- Previous diagnosis of respiratory or neurological diseases
- Previous surgeries, fractures, and dislocations in the dominant shoulder
- Inability to follow instructions during the study
- All those for whom measuring maximum inspiratory pressure is contraindicated: unstable angina, recent myocardial infarction (within 4 weeks of the even or myocarditis, uncontrolled systemic hypertension, recent pneumothorax, post-lung biopsy surgery of less than one week, postoperative abdominal or genitourinary surgery of less than 6 months, and urinary incontinence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inspiratory Muscle Strength and Diaphragm Thickness in Tennis Players With and Without Shoulder Pain: A Case-Control Study
This observational case-control study will compare inspiratory muscle function and diaphragm morphology between individuals with shoulder pain and asymptomatic controls. Participants will be allocated into two groups according to the presence or absence of shoulder pain.
Inspiratory muscle strength will be assessed by measuring maximal inspiratory pressure (MIP) using standardized procedures. Diaphragm thickness will be evaluated bilaterally using ultrasound imaging at the end of inspiration (Tins) and at the end of expiration (Texp).
Read more
Pain intensity will be assessed using the Visual Analog Scale (VAS). Upper limb disability will be evaluated using the QuickDASH questionnaire, including the activities of daily living module and the optional sports module.
All outcomes will be assessed in a single evaluation session. Between-group comparisons will be performed to analyze differences in inspiratory muscle strength, diaphragm thickness, pain intensity, and upper limb disability between participants with and without shoulder pain.
- Conditions
- Shoulder Pain
- Keywords
- Shoulder pain, diaphragm, Maximal inspiratory pressure, Ultrasound imaging
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Shoulder Pain Group | Participants with shoulder pain | |
| Healthy Control Group | Participants without shoulder pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory Pressure (MIP)
Maximal inspiratory pressure measured in cmH₂O using a respiratory pressure meter as an indicator of inspiratory muscle strength.
Measured: Single assessment at baseline visit
Diaphragm thickness at inspiration
Bilateral diaphragm muscle thickness measured by ultrasound imaging at the end of maximal inspiration (Tins)
Measured: Single assessment at baseline visit
Diaphragm thickness at expiration
Bilateral diaphragm muscle thickness measured by ultrasound imaging at the end of maximal expiration (Texp).
Measured: Single assessment at baseline visit
Secondary outcomes (3)
Pain intensity (VAS)
Shoulder pain intensity assessed using the Visual Analog Scale (VAS) ranging from 0 to 10, where 0 = no pain and 10 = worst imaginable pain; higher scores indicate worse pain
Measured: Single assessment at baseline visit
Upper limb disability - activities of daily living
Upper limb disability in activities of daily living assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH-Core) questionnaire (11 items). Scores range from 0 to 100, where 0 = no disability and 100 = most severe disability; higher scores indicate worse disability.
Measured: Single assessment at baseline visit
Upper limb disability - sport
Upper limb disability in sport activities assessed using the Quick Disabilities of the Arm, Shoulder and Hand Sport module (4 ítems). Scores range from 0 to 100, where 0 = no disability and 100 = most severe disability; higher scores indicate worse disability.
Measured: Single assessment at baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Feb 2026
- Primary completion1 Mar 2026
- Study completion20 Mar 2026
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334171
- Sponsor's protocol ID
- SHOULDER-DIAPH-01
- Acronym
- SHOULDER-DIAPH
- Status last verified
- Apr 2026
- First submitted
- 3 Jan 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time, it is unclear whether individual participant data (IPD) will be shared. Data sharing will depend on institutional policies, ethical approvals, participant privacy considerations, and the feasibility of preparing de-identified datasets. A final decision will be made once data collection and analysis are completed.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Strength and Diaphragm Thickness in Tennis Players With and Without Shoulder Pain: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07334171
- Acronym / sponsor ID
- SHOULDER-DIAPH / SHOULDER-DIAPH-01
- Conditions
- Shoulder Pain
- Keywords
- Shoulder pain, diaphragm, Maximal inspiratory pressure, Ultrasound imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 12 Jan 2026 (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 observational case-control study will compare inspiratory muscle function and diaphragm morphology between individuals with shoulder pain and asymptomatic controls. Participants will be allocated into two groups according to the presence or absence of shoulder pain.
Inspiratory muscle strength will be assessed by measuring maximal inspiratory pressure (MIP) using standardized procedures. Diaphragm thickness will be evaluated bilaterally using ultrasound imaging at the end of inspiration (Tins) and at the end of expiration (Texp).
Pain intensity will be assessed using the Visual Analog Scale (VAS). Upper limb disability will be evaluated using the QuickDASH questionnaire, including the activities of daily living module and the optional sports module.
All outcomes will be assessed in a single evaluation session. Between-group comparisons will be performed to analyze differences in inspiratory muscle strength, diaphragm thickness, pain intensity, and upper limb disability between participants with and without shoulder pain.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shoulder Pain Group | – | –Participants with shoulder pain |
| Healthy Control Group | – | –Participants without shoulder pain |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult racket sport players aged 18 to 60 years, both with and without non-specific shoulder pain, recruited from local sports clubs and university-related facilities.
Key inclusion criteria (4 listed)
- Tennis player who suffered from non-specific shoulder pain
- Training at least two times per week
- Have experienced at least 1 episode of non-specific shoulder pain in the last month
- A positive result on the following diagnostic tests: Neer Test and Jobe Test
Key exclusion criteria (6 listed)
- Having taken anti-inflammatories or muscle relaxants within the last 72 hours before the study
- Pregnancy
- Previous diagnosis of respiratory or neurological diseases
- Previous surgeries, fractures, and dislocations in the dominant shoulder
- Inability to follow instructions during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximal Inspiratory Pressure (MIP)
Time frame: Single assessment at baseline visit
Maximal inspiratory pressure measured in cmH₂O using a respiratory pressure meter as an indicator of inspiratory muscle strength.
Diaphragm thickness at inspiration
Time frame: Single assessment at baseline visit
Bilateral diaphragm muscle thickness measured by ultrasound imaging at the end of maximal inspiration (Tins)
Diaphragm thickness at expiration
Time frame: Single assessment at baseline visit
Bilateral diaphragm muscle thickness measured by ultrasound imaging at the end of maximal expiration (Texp).
3 secondary outcomes
Pain intensity (VAS)
Time frame: Single assessment at baseline visit
Upper limb disability - activities of daily living
Time frame: Single assessment at baseline visit
Upper limb disability - sport
Time frame: Single assessment at baseline visit
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 28 Apr 2026.
- Individual participant dataSharing planned: Undecided. At this time, it is unclear whether individual participant data (IPD) will be shared. Data sharing will depend on institutional policies, ethical approvals, participant privacy considerations, and the feasibility of preparing de-identified datasets. A final decision will be made once data collection and analysis are completed.
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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?
An observational study of Shoulder Pain, run by Universidad Francisco de Vitoria 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 4 inclusion and 6 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 28 Apr 2026. 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?
Maximal Inspiratory Pressure (MIP) (time frame: Single assessment at baseline visit). 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 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.