NCT07334171

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2026

Completed
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

28 days

First QC Date

January 3, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

Shoulder paindiaphragmMaximal inspiratory pressureUltrasound imaging

Outcome Measures

Primary Outcomes (3)

  • Maximal Inspiratory Pressure (MIP)

    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

    Bilateral diaphragm muscle thickness measured by ultrasound imaging at the end of maximal inspiration (Tins)

    Single assessment at baseline visit

  • Diaphragm thickness at expiration

    Bilateral diaphragm muscle thickness measured by ultrasound imaging at the end of maximal expiration (Texp).

    Single assessment at baseline visit

Secondary Outcomes (3)

  • Pain intensity (VAS)

    Single assessment at baseline visit

  • Upper limb disability - activities of daily living

    Single assessment at baseline visit

  • Upper limb disability - sport

    Single assessment at baseline visit

Study Arms (2)

Shoulder Pain Group

Participants with shoulder pain

Healthy Control Group

Participants without shoulder pain

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Francisco de Vitoria

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2026

First Posted

January 12, 2026

Study Start

February 1, 2026

Primary Completion

March 1, 2026

Study Completion

March 20, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations