Ultrasonography Biofeedback for Diaphragm Training in Athletes With Non-specific Lumbo-pelvic Pain

Low Back Pain Clinical Trial

Official title:

Effectiveness of Ultrasonography Visual Biofeedback for Diaphragm Training in Athletes With Non-specific Lumbo-pelvic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04097873
• Other study ID #: Ultrasonography-PR65/19-UCM
• Status: Completed
• Phase: N/A
• Start date: July 21, 2020
• Est. completion date: June 13, 2022

Study information

• Verified date: June 2022
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: To determine the effectiveness of diaphragm visual biofeedback reeducation by ultrasonography in conjunction with high-intensity inspiratory muscle training versus isolated high-intensity inspiratory muscle training in athletes with lumbo-pelvic pain. Methods: A single blinded randomized clinical trial will be carried out. A total sample of 80 athletes with lumbo-pelvic pain will be recruited and randomized into 2 groups: one group will be treated by isolated high-intensity inspiratory muscle training during 8 weeks, and another group will be treated with diaphragm visual biofeedback reeducation by ultrasonography during 6 weeks in conjunction with high-intensity inspiratory muscle training during 8 weeks. Outcome measurements will be diaphragm muscle thickness evaluated by ultrasonography (main outcome measurement), pain intensity, pressure pain threshold, disability, quality of life and respiratory parameters by spirometry, which will be assessed before and after intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 13, 2022
• Est. primary completion date: April 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Athletes with non-specific lumbopelvic pain during 6 weeks

Exclusion Criteria:

• Neural disorders

• Systemic disorders

• Cognitive disorders

Related Conditions & MeSH terms

• Low Back Pain
• Pelvic Pain
• Ultrasonography

Intervention

Other:
• Diaphragm ultrasonography reeducation plus inspiratory training
Diaphragm biofeedback reeducation plus inspiratory training during 6 weeks
• Isolated inspiratory training
Isolated high-intensity inspiratory muscle training during 8 weeks

Locations

Country	Name	City	State
Spain	Universidad Complutense de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Calvo-Lobo C, Almazán-Polo J, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Palomo-López P, Rodríguez-Sanz D, López-López D. Ultrasonography comparison of diaphragm thickness and excursion between athletes with and without lumbopelvic pain. Phys Ther Sport. 2019 May;37:128-137. doi: 10.1016/j.ptsp.2019.03.015. Epub 2019 Mar 28. — View Citation

Calvo-Lobo C, Diez-Vega I, Martínez-Pascual B, Fernández-Martínez S, de la Cueva-Reguera M, Garrosa-Martín G, Rodríguez-Sanz D. Tensiomyography, sonoelastography, and mechanosensitivity differences between active, latent, and control low back myofascial trigger points: A cross-sectional study. Medicine (Baltimore). 2017 Mar;96(10):e6287. doi: 10.1097/MD.0000000000006287. — View Citation

Calvo-Lobo C, Painceira-Villar R, López-López D, García-Paz V, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Palomo-López P. Tarsal Tunnel Mechanosensitivity Is Increased in Patients with Asthma: A Case-Control Study. J Clin Med. 2018 Dec 12;7(12). pii: E541. doi: 10.3390/jcm7120541. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragm muscle thickness	Diaphragm muscle thickness in centimeters evaluated by ultrasonography	Change from Baseline diaphragm muscle thickness at 8 weeks
Secondary	Pain intensity	Pain intensity scores evaluated by the Visual Analogue Scale from 0 (No pain) to 100 millimeters (Worst pain)	Change from Baseline pain intensity at 8 weeks
Secondary	Pressure pain threshold	Pressure pain threshold in kilograms / squared centimeter evaluated by algometer	Change from Baseline pressure pain threshold at 8 weeks
Secondary	Disability	Disability scores evaluated by the self-reported Roland-Morris Disability Questionnaire from 0 (no disability) to 24 points (Maximum disability)	Change from Baseline disability at 8 weeks
Secondary	Health-related quality of life scores	Quality of life scores evaluated by the self-reported Medical Outcomes Study Short-Form 36 questionnaire from 0 (lowest health-related quality of life) to 100 (highest health-related quality of life)	Change from Baseline health-related quality of life scores at 8 weeks
Secondary	Respiratory parameters percentage	Respiratory parameters percentage evaluated by spirometry	Change from Baseline respiratory parameters percentage at 8 weeks