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

Not Applicable

• Conditions: Ultrasonography; Low Back Pain
• Interventions: Other: Experimental; Other: Active comparator

• Registration Number: NCT04097392
• Lead Sponsor: Universidad de León

Brief Summary

Objective: To determine the effectiveness of diaphragm 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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-17
• Study First Submitted QC: 2019-09-18
• Last Update Submitted: 2019-09-18
• Study First Posted: 2019-09-20
• Last Update Posted: 2019-09-20
• Study Start: 2020-05-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Athletes with non-specific lumbopelvic pain during 6 weeks

Exclusion Criteria

• Neural disorders
• Systemic disorders
• Cognitive disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diaphragm biofeedback reeducation plus inspiratory training	Experimental	-
Isolated high-intensity inspiratory muscle training	Active comparator	-

Primary Outcome Measures

Name	Time	Method
Diaphragm muscle thickness	Change from Baseline diaphragm muscle thickness at 8 weeks	Diaphragm muscle thickness evaluated in centimeters by ultrasonography

Secondary Outcome Measures

Name	Time	Method
Pressure pain threshold	Change from Baseline pressure pain threshold at 8 weeks	Pressure pain threshold evaluated in kilograms / squared centimeter by algometer

Trial Locations

Locations (1)

Universidad Complutense de Madrid; 🇪🇸 Madrid, Spain