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Clinical Trials/NCT04097392
NCT04097392
Unknown
Not Applicable

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

Universidad de León1 site in 1 country80 target enrollmentMay 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ultrasonography
Sponsor
Universidad de León
Enrollment
80
Locations
1
Primary Endpoint
Diaphragm muscle thickness
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2020
End Date
May 1, 2022
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidad de León
Responsible Party
Principal Investigator
Principal Investigator

César Calvo Lobo

Principal Investigator

Universidad Complutense de Madrid

Eligibility Criteria

Inclusion Criteria

  • Athletes with non-specific lumbopelvic pain during 6 weeks

Exclusion Criteria

  • Neural disorders
  • Systemic disorders
  • Cognitive disorders

Outcomes

Primary Outcomes

Diaphragm muscle thickness

Time Frame: Change from Baseline diaphragm muscle thickness at 8 weeks

Diaphragm muscle thickness evaluated in centimeters by ultrasonography

Secondary Outcomes

  • Pressure pain threshold(Change from Baseline pressure pain threshold at 8 weeks)

Study Sites (1)

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