Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Strength and Shoulder Pain in Tennis Player

Shoulder Pain Clinical Trial

Official title:

Effects of Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Strength and Non-especific Shoulder Pain in Federated Tennis Player

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06186180
• Other study ID #: 46/2022
• Status: Recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: February 2024

Study information

• Verified date: October 2023
• Source: Universidad Francisco de Vitoria
• Contact: Davinia Vicente-Campos
• Phone: 627900087
• Email: davinia.vicente[@]ufv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Inspiratory Muscle Training
• Respiratory Aspiration
• Shoulder Pain

Intervention

Other:
• 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

Locations

Country	Name	City	State
Spain	Davinia Vicente-Campos	Pozuelo De Alarcón	Madrid
Spain	Universidad Francisco de Vitoria	Pozuelo de Alarcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Francisco de Vitoria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	maximal inspiratory pressure	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	before and after the 8 weeks of inspiratory muscle training
Secondary	shoulder pain through VAS	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	before and after the 8 weeks of inspiratory muscle training
Secondary	Upper trapezius, levator scapulae and middle deltoid pain pressure threshold	the measurement of pressure pain using an algometer will be performed at the upper trapezius, the levator scapulae, and the middle deltoid, 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	before and after the 8 weeks of inspiratory muscle training
Secondary	The Shortened Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH)	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	before and after the 8 weeks of inspiratory muscle training