- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06186180
Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Strength and Shoulder Pain in Tennis Player
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Madrid
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Pozuelo de Alarcón, Madrid, Spain, 28223
- Universidad Francisco de Vitoria
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Pozuelo de Alarcón, Madrid, Spain, 28223
- Davinia Vicente-Campos
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: control
no intervention
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Experimental: inspiratory muscle training
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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
diaphragm thickness
Time Frame: before and after the 8 weeks of inspiratory muscle training
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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
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before and after the 8 weeks of inspiratory muscle training
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
maximal inspiratory pressure
Time Frame: before and after the 8 weeks of inspiratory muscle training
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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
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before and after the 8 weeks of inspiratory muscle training
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shoulder pain through VAS
Time Frame: before and after the 8 weeks of inspiratory muscle training
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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
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before and after the 8 weeks of inspiratory muscle training
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Upper trapezius, levator scapulae, middle deltoid and infraspinatus pain pressure threshold
Time Frame: before and after the 8 weeks of inspiratory muscle training
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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
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before and after the 8 weeks of inspiratory muscle training
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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
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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
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before and after the 8 weeks of inspiratory muscle training
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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
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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.
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before and after the 8 weeks of inspiratory muscle training
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 46/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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