Inspiratory Muscle Strength and Diaphragm Thickness in People With Shoulder Pain in Tennis Players (SHOULDER-DIAPH)

April 27, 2026 updated by: Universidad Francisco de Vitoria

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

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Universidad Francisco de Vitoria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Shoulder Pain Group
Participants with shoulder pain
Healthy Control Group
Participants without shoulder pain

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
Maximal inspiratory pressure measured in cmH₂O using a respiratory pressure meter as an indicator of inspiratory muscle strength.
Single assessment at baseline visit
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)
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).
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
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
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.
Single assessment at baseline visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Actual)

March 1, 2026

Study Completion (Actual)

March 20, 2026

Study Registration Dates

First Submitted

January 3, 2026

First Submitted That Met QC Criteria

January 3, 2026

First Posted (Actual)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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