- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07334171
Inspiratory Muscle Strength and Diaphragm Thickness in People With Shoulder Pain in Tennis Players (SHOULDER-DIAPH)
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).
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
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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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
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 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Shoulder Pain Group
Participants with shoulder pain
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Healthy Control Group
Participants without shoulder pain
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximal Inspiratory Pressure (MIP)
Time Frame: Single assessment at baseline visit
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Maximal inspiratory pressure measured in cmH₂O using a respiratory pressure meter as an indicator of inspiratory muscle strength.
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Single assessment at baseline visit
|
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Diaphragm thickness at inspiration
Time Frame: Single assessment at baseline visit
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Bilateral diaphragm muscle thickness measured by ultrasound imaging at the end of maximal inspiration (Tins)
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Single assessment at baseline visit
|
|
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).
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Single assessment at baseline visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity (VAS)
Time Frame: Single assessment at baseline visit
|
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
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Single assessment at baseline visit
|
|
Upper limb disability - activities of daily living
Time Frame: Single assessment at baseline visit
|
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.
|
Single assessment at baseline visit
|
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Upper limb disability - sport
Time Frame: Single assessment at baseline visit
|
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.
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Single assessment at baseline visit
|
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
- SHOULDER-DIAPH-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Clinical Trials on Shoulder Pain
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Universidad de ZaragozaAragon Institute for Health Research (IIS Aragón)CompletedShoulder Pain Syndrome | Nonspecific Shoulder PainSpain
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Deraya UniversityNot yet recruitingAdhesive Capsulitis of Shoulder | Frozen Shoulder | Shoulder Pain and StiffnessEgypt
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Istanbul UniversityRecruitingSubacromial Pain Syndrome | Shoulder Pain Syndrome | Rotator Cuff Related Shoulder PainTurkey (Türkiye)
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Şeyhmus KAPLANCompletedSubacromial Impingement | Pain, Shoulder