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

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ClinicalTrials.gov Identifier: NCT04097392
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
César Calvo Lobo, Universidad Complutense de Madrid

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.

Condition or disease Intervention/treatment Phase
Ultrasonography Low Back Pain Other: Experimental Other: Active comparator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Ultrasonography Biofeedback for Diaphragm Training in Athletes With Non-specific Lumpo-pelvic Pain
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diaphragm biofeedback reeducation plus inspiratory training Other: Experimental
Diaphragm biofeedback reeducation plus inspiratory training during 6 weeks

Active Comparator: Isolated high-intensity inspiratory muscle training Other: Active comparator
Isolated high-intensity inspiratory muscle training during 8 weeks




Primary Outcome Measures :
  1. Diaphragm muscle thickness [ Time Frame: Change from Baseline diaphragm muscle thickness at 8 weeks ]
    Diaphragm muscle thickness evaluated in centimeters by ultrasonography


Secondary Outcome Measures :
  1. Pressure pain threshold [ Time Frame: Change from Baseline pressure pain threshold at 8 weeks ]
    Pressure pain threshold evaluated in kilograms / squared centimeter by algometer



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Athletes with non-specific lumbopelvic pain during 6 weeks

Exclusion Criteria:

  • Neural disorders
  • Systemic disorders
  • Cognitive disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097392


Contacts
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Contact: César Calvo Lobo, PhD 0034 913 94 15 36 cescalvo@ucm.es

Locations
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Spain
Universidad Complutense de Madrid Not yet recruiting
Madrid, Spain, 28040
Contact: César Calvo Lobo, PhD    0034 913 94 15 36    cescalvo@ucm.es   
Sponsors and Collaborators
Universidad de León

Publications:
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Responsible Party: César Calvo Lobo, Principal Investigator, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT04097392     History of Changes
Other Study ID Numbers: UCM PR65/19
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms