Shoulder PainNCT06186180
Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Strength and Shoulder Pain in Tennis Player
A study testing inspiratory muscle training in people with Shoulder Pain and Inspiratory Muscle Training, run by Universidad Francisco de Vitoria at 2 sites in Spain.
Trial summary
Shoulder pain is one of the most common musculoskeletal conditions among athletes and sports enthusiasts who engage in overhead sports, and it can be highly disabling. Since the shoulder is one of the joints with the greatest range of motion in the human body, it is important to seek strategies that address trunk… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Shoulder Pain, Inspiratory Muscle Training
- What is being tested?
- inspiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Nov 2025to 15 Apr 2026
- 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
- No healthy volunteers
- Adult
Who may be able to join
- tennis player who suffered from inespecific 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 diagnostic tests performed: 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 event) 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
2 sites in 1 country.
Spain2 sites
Davinia Vicente-Campos
Pozuelo de Alarcón, Madrid, 28223
Universidad Francisco de Vitoria
Pozuelo de Alarcón, Madrid, 28223
About this study
Official title: Effects of Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Strength and Non-especific Shoulder Pain in Federated Tennis Player
Shoulder pain is one of the most common musculoskeletal conditions among athletes and sports enthusiasts who engage in overhead sports, and it can be highly disabling. Since the shoulder is one of the joints with the greatest range of motion in the human body, it is important to seek strategies that address trunk stability comprehensively to achieve full and effective joint mobility. The central role of the diaphragm in trunk stabilization has been the subject of research for over 50 years, although the exact mechanisms are still not fully understood.
The objective of this study is to assess the effects of inspiratory muscle training on diaphragm thickness, inspiratory muscle strength, and shoulder pain in adult tennis players with non-specific shoulder pain.
This is a single-blind, randomized controlled clinical trial. The intervention will last for 8 weeks. Patients with non-specific shoulder pain will be randomly assigned to one of two groups. The experimental group will undergo specific inspiratory muscle training, while the control group will receive no specific training intervention. Measurements of diaphragm thickness, inspiratory muscle strength, and shoulder pain will be taken before and after the intervention.
- Conditions
- Shoulder Pain, Inspiratory Muscle Training
- Being tested
- inspiratory muscle training
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle trainingOther
They will perform 5 sets of 10 repetitions with a 1-minute rest between sets, 5 days a week, using a specific respiratory muscle training device
| Study group | Role | What they receive |
|---|---|---|
| inspiratory muscle training | Experimental | They will perform 5 sets of 10 repetitions with a 1-minute rest between sets, 5 days a week, using a specific respiratory muscle training device. Receives: Other: inspiratory muscle training |
| control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
diaphragm thickness
The thickness of the diaphragm will be measured using ultrasound, with a Toshiba Xario 100 ultrasound machine. Image acquisition will be performed by a physiotherapist experienced in musculoskeletal ultrasound. A linear probe (Toshiba PLT-805AT) with a frequency range of 8 to 12 MHz and a 54 mm probe footprint will be used to perform transcostal measurements at rest and in the supine position, using the B-Mode of ultrasound imaging (preset at 3 cm depth, 12MHz frequency, 64 gain points, 64 dynamic range points, and a single focus point located at 2 cm depth). Bilateral transcostal images will be obtained with the linear probe placed perpendicular to the last intercostal space, allowing for adequate visualization of the diaphragm without invasion of lung tissue during normal breathing
Measured: before and after the 8 weeks of inspiratory muscle training
Secondary outcomes (5)
maximal inspiratory pressure
Inspiratory muscle strength will be measured using a portable device, POWERbreathe KH1. It is a simple test in which the subject performs a maximal forced inspiration against an airway occlusion mechanism in the mouth after a slow and prolonged near-residual volume expiration, yielding the maximum inspiratory pressure (MIP) value. The evaluation will be conducted with the subject seated in a chair (knees and hips at 90º), and their nose will be occluded with a clip. The advantage of this test is that it provides a quick and non-invasive way to assess inspiratory muscle strength through maximum inspiratory pressure. Three measurements will be taken, with 1 minute of rest between each measurement, and the best of the three will be selected, provided that there is no more than a 10% difference between them
Measured: before and after the 8 weeks of inspiratory muscle training
shoulder pain through VAS
Shoulder pain will be measured using the Visual Analog Scale for Pain (VAS), which is a valid and reliable measure for assessing pain. Its validity has been demonstrated with high correlations to other pain measures (r=0.62 to 0.91), and it has good test-retest reliability (r=0.94 to 0.71)(31). Participants will indicate their maximum pain sensation during the past week using a 100-mm VAS, where 0 represents 'no pain' and 100 represents 'extreme and unbearable pain
Measured: before and after the 8 weeks of inspiratory muscle training
Upper trapezius, levator scapulae, middle deltoid and infraspinatus pain pressure threshold
the measurement of pressure pain using an algometer will be performed at the upper trapezius, the levator scapulae, the middle deltoid, and the infraspinatus muscle as shown by studies at the shoulder level. The contact area will be 10mm, and it will be applied at a rate of 30 kPa/s. Patients will be instructed to signal the moment they feel the first sensation of pain
Measured: before and after the 8 weeks of inspiratory muscle training
The Shortened Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH) - Activities of daily living score
The Shortened Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH) consists of 11 questions that assess daily activities, symptoms, social function, work function, sleep, and confidence. There are 5 points, with 1 indicating no difficulty and 5 indicating impossibility. The score is converted to a 100-point scale, with 100 representing the highest level of disability
Measured: before and after the 8 weeks of inspiratory muscle training
The Shortened Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH) - Sports Module Score
The QuickDASH Sports Module score will be used to assess the impact of arm, shoulder, or hand symptoms on the partipiants ability to perfom sport-related activites. This optional module includes 4 items focused on difficulty performing the selected sport or physical activity during the previous week. Each items is scored on a 5-point linkert scale. The final score is transformed to a 0-100 scale, where 0 indicates no disability and 100 indicates the graetest disability. All 4 items must be completed to calculate the module score.
Measured: before and after the 8 weeks of inspiratory muscle training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 Nov 2025
- Primary completion15 Feb 2026
- Study completion15 Apr 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Single blinded randomized clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 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
- NCT06186180
- Sponsor's protocol ID
- 46/2022
- Status last verified
- May 2026
- First submitted
- 8 Dec 2023
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Strength and Non-especific Shoulder Pain in Federated Tennis Player
- ClinicalTrials.gov ID
- NCT06186180
- Acronym / sponsor ID
- 46/2022
- Conditions
- Shoulder Pain, Inspiratory Muscle Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 29 Dec 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.
Shoulder pain is one of the most common musculoskeletal conditions among athletes and sports enthusiasts who engage in overhead sports, and it can be highly disabling. Since the shoulder is one of the joints with the greatest range of motion in the human body, it is important to seek strategies that address trunk stability comprehensively to achieve full and effective joint mobility. The central role of the diaphragm in trunk stabilization has been the subject of research for over 50 years, although the exact mechanisms are still not fully understood.
The objective of this study is to assess the effects of inspiratory muscle training on diaphragm thickness, inspiratory muscle strength, and shoulder pain in adult tennis players with non-specific shoulder pain.
This is a single-blind, randomized controlled clinical trial. The intervention will last for 8 weeks. Patients with non-specific shoulder pain will be randomly assigned to one of two groups. The experimental group will undergo specific inspiratory muscle training, while the control group will receive no specific training intervention. Measurements of diaphragm thickness, inspiratory muscle strength, and shoulder pain will be taken before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single blinded randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| inspiratory muscle training | Experimental | Other: inspiratory muscle trainingThey will perform 5 sets of 10 repetitions with a 1-minute rest between sets, 5 days a week, using a specific respiratory muscle training device. |
| control | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- tennis player who suffered from inespecific 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 diagnostic tests performed: 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inspiratory muscle trainingThey will perform 5 sets of 10 repetitions with a 1-minute rest between sets, 5 days a week, using a specific respiratory muscle training device | Other | inspiratory muscle training |
Primary outcome
diaphragm thickness
Time frame: before and after the 8 weeks of inspiratory muscle training
The thickness of the diaphragm will be measured using ultrasound, with a Toshiba Xario 100 ultrasound machine. Image acquisition will be performed by a physiotherapist experienced in musculoskeletal ultrasound. A linear probe (Toshiba PLT-805AT) with a frequency range of 8 to 12 MHz and a 54 mm probe footprint will be used to perform transcostal measurements at rest and in the supine position, using the B-Mode of ultrasound imaging (preset at 3 cm depth, 12MHz frequency, 64 gain points, 64 dynamic range points, and a single focus point located at 2 cm depth). Bilateral transcostal images will be obtained with the linear probe placed perpendicular to the last intercostal space, allowing for adequate visualization of the diaphragm without invasion of lung tissue during normal breathing
5 secondary outcomes
maximal inspiratory pressure
Time frame: before and after the 8 weeks of inspiratory muscle training
shoulder pain through VAS
Time frame: before and after the 8 weeks of inspiratory muscle training
Upper trapezius, levator scapulae, middle deltoid and infraspinatus pain pressure threshold
Time frame: before and after the 8 weeks of inspiratory muscle training
The Shortened Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH) - Activities of daily living score
Time frame: before and after the 8 weeks of inspiratory muscle training
The Shortened Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH) - Sports Module Score
Time frame: before and after the 8 weeks of inspiratory muscle training
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 8 May 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory muscle training in people with Shoulder Pain and Inspiratory Muscle Training, run by Universidad Francisco de Vitoria at 2 sites 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 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
diaphragm thickness (time frame: before and after the 8 weeks of inspiratory muscle training). 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 8 May 2026.