NCT06186180

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

December 8, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 29, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

December 29, 2023

Status Verified

October 1, 2023

Enrollment Period

Same day

First QC Date

December 8, 2023

Last Update Submit

December 15, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    before and after the 8 weeks of inspiratory muscle training

Secondary Outcomes (4)

  • maximal inspiratory pressure

    before and after the 8 weeks of inspiratory muscle training

  • shoulder pain through VAS

    before and after the 8 weeks of inspiratory muscle training

  • Upper trapezius, levator scapulae and middle deltoid pain pressure threshold

    before and after the 8 weeks of inspiratory muscle training

  • The Shortened Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH)

    before and after the 8 weeks of inspiratory muscle training

Study Arms (2)

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.

Other: inspiratory muscle training

control

NO INTERVENTION

no intervention

Interventions

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

inspiratory muscle training

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Davinia Vicente-Campos

Pozuelo de Alarcón, Madrid, 28223, Spain

RECRUITING

Universidad Francisco de Vitoria

Pozuelo de Alarcón, Madrid, 28223, Spain

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Davinia Vicente-Campos

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single blinded randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2023

First Posted

December 29, 2023

Study Start

January 1, 2024

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

December 29, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations